Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2026-03-06 @ 11:17 AM
Study NCT ID:
NCT01881828
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2013-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Metformin Therapy for Overweight Adolescents With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 't1dstats@jaeb.org', 'phone': '15310 Amberly Drive', 'title': 'Kellee Miller', 'organization': 'Jaeb Center for Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.', 'otherNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo', 'otherNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'classes': [{'title': 'HbA1c', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '9.2'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '9.2'}]}]}, {'title': 'Change from Baseline to 26 Weeks', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-26 weeks', 'description': 'Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'classes': [{'title': 'HbA1c Decrease ≥0.5%', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c Increase ≥0.5%', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'HbA1c <7.5%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-26 weeks', 'description': 'Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Total Daily Dose of Insulin (TDI) Per kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '-0.1'}, {'value': '-0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '-0.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-26 weeks', 'unitOfMeasure': 'insulin per kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '0'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-0.0', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-26 weeks', 'unitOfMeasure': 'percentile', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-26 weeks', 'unitOfMeasure': 'centimeters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-26 weeks', 'description': 'Change in percent body fat', 'unitOfMeasure': 'percentage of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Lipids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'classes': [{'title': 'Change in LDL', 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-11', 'upperLimit': '-0'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '7'}]}]}, {'title': 'Change in VLDL', 'categories': [{'measurements': [{'value': '-0', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '3'}]}]}, {'title': 'Change in HDL', 'categories': [{'measurements': [{'value': '-0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '2'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '1'}]}]}, {'title': 'Change in Triglycerides', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '13'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '17'}]}]}, {'title': 'Change in Total Cholesterol', 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-11', 'upperLimit': '1'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '-3', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-26 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'classes': [{'title': 'Change in Systolic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0', 'upperLimit': '0'}, {'value': '-0', 'groupId': 'OG001', 'lowerLimit': '-0', 'upperLimit': '0'}]}]}, {'title': 'Change in Diastolic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-0', 'upperLimit': '0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0-26 weeks', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Liver Enzymes and Serum Creatinine', 'timeFrame': '0-26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Severe Hypoglycemia', 'timeFrame': '26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Diabetic Ketoacidosis', 'timeFrame': '26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Gastrointestinal Side-effects Including Stomach Discomfort, Diarrhea, Nausea/Vomiting, Indigestion, Flatulence.', 'timeFrame': '26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Lactic Acidosis', 'timeFrame': '26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Adipocytokines', 'timeFrame': '0-26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Androgen Levels in Females', 'timeFrame': '0-26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in C-peptide', 'timeFrame': '0-26-weeks', 'description': 'Measured with mixed meal tolerance test among participants with evidence of residual C-peptide on a non-fasting C-peptide at screening', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Vascular Dysfunction', 'timeFrame': '0-26 weeks', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'FG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '23 excluded at randomization from enrollment', 'groupId': 'FG000', 'numSubjects': '71'}, {'comment': '23 excluded from randomization from enrollment', 'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metformin', 'description': 'Metformin 2000 mg per day\n\nMetformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.'}, {'id': 'BG001', 'title': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary\n\noral placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '15.1', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '15.3', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '12-15 years', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': '16-19 years', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '3.0', 'groupId': 'BG001'}, {'value': '7.0', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes (group)', 'classes': [{'title': '1-2 Years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': '3-5 Years', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': '6-8 Years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': '≥ 9 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Body Mass Index (BMI) Z Score', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.3', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '0.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean.', 'unitOfMeasure': 'Z score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI) Percentile Group', 'classes': [{'title': 'Overweight: 85th-<95th%', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Obese: ≥ 95th %', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tanner Staging (Pubic Hair)', 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Stage 4', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Stage 5', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'For all three sites of development, Tanner Stage 1 corresponds to the pre-pubertal form with progression to Tanner Stage 5, the final adult form.', 'unitOfMeasure': 'participants'}, {'title': 'Tanner Staging (Breasts/Genitals)', 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Stage 4', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Stage 5', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'For all three sites of development, Tanner Stage 1 corresponds to the pre-pubertal form with progression to Tanner Stage 5, the final adult form.', 'unitOfMeasure': 'participants'}, {'title': 'Highest Parent Educaiton Level', 'classes': [{'title': 'High school diploma, GED, or less', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Associate', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Bachelor', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Master', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Professional', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Unknown / Do not want to answer', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Income Category', 'classes': [{'title': 'Less than $35,000', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '$35,000 to less than $50,000', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '$50,000 to less than $75,000', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': '$75,000 to less than $100,000', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': '$100,000 to less than $200,000', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Unknown / Do not want to answer', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Insurance', 'classes': [{'title': 'Private Insurance', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Other Insurance', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Unknown / Do not want to answer', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Severe Hypoglycemia Events Since T1D Diagnosis', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': '1-2 episodes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': '3-4 episodes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '≥ 5 episodes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'episodes'}, {'title': 'Diabetic Ketoacidosis Events Since T1D Diagnosis', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': '1-2 episodes', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': '3-4 episodes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '≥ 5 episodes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'episodes'}, {'title': 'HbA1c Lab', 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '8.8', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c Group', 'classes': [{'title': '< 8.5%', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': '8.5%-9.4%', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': '≥ 9.5%', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean Sensor Glucose', 'classes': [{'categories': [{'measurements': [{'value': '206', 'spread': '35', 'groupId': 'BG000'}, {'value': '208', 'spread': '34', 'groupId': 'BG001'}, {'value': '207', 'spread': '34.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Insulin Pump Use', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Continuous Glucose Monitor Use', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Self-Monitoring of Blood Glucose per day', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of checks per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Self-Monitoring of Blood Glucose group', 'classes': [{'title': '3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': '4-5', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}, {'title': '≥ 6', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Total Daily Insulin', 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.1', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'unit/kg/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Daily Insulin Group', 'classes': [{'title': '<1.0', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': '1.0-1.4', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}, {'title': '≥ 1.5', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Total Basal/Long Acting Insulin', 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '0.5', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'unit/kg/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI) Percentile', 'classes': [{'categories': [{'measurements': [{'value': '93.7', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '94.3', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '94', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentile', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-28', 'studyFirstSubmitDate': '2013-06-13', 'resultsFirstSubmitDate': '2017-03-10', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-17', 'studyFirstPostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Liver Enzymes and Serum Creatinine', 'timeFrame': '0-26 weeks'}, {'measure': 'Frequency of Severe Hypoglycemia', 'timeFrame': '26 weeks'}, {'measure': 'Frequency of Diabetic Ketoacidosis', 'timeFrame': '26 weeks'}, {'measure': 'Frequency of Gastrointestinal Side-effects Including Stomach Discomfort, Diarrhea, Nausea/Vomiting, Indigestion, Flatulence.', 'timeFrame': '26 weeks'}, {'measure': 'Frequency of Lactic Acidosis', 'timeFrame': '26 weeks'}, {'measure': 'Change in Adipocytokines', 'timeFrame': '0-26 weeks'}, {'measure': 'Change in Androgen Levels in Females', 'timeFrame': '0-26 weeks'}, {'measure': 'Change in C-peptide', 'timeFrame': '0-26-weeks', 'description': 'Measured with mixed meal tolerance test among participants with evidence of residual C-peptide on a non-fasting C-peptide at screening'}, {'measure': 'Change in Vascular Dysfunction', 'timeFrame': '0-26 weeks'}], 'primaryOutcomes': [{'measure': 'Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.', 'timeFrame': '0-26 weeks', 'description': 'Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months'}], 'secondaryOutcomes': [{'measure': 'Change in Total Daily Dose of Insulin (TDI) Per kg', 'timeFrame': '0-26 weeks'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': '0-26 weeks'}, {'measure': 'Change in Waist Circumference', 'timeFrame': '0-26 weeks'}, {'measure': 'Change in Body Composition', 'timeFrame': '0-26 weeks', 'description': 'Change in percent body fat'}, {'measure': 'Change in Serum Lipids', 'timeFrame': '0-26 weeks'}, {'measure': 'Change in Blood Pressure', 'timeFrame': '0-26 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '14514594', 'type': 'BACKGROUND', 'citation': 'Libman IM, Pietropaolo M, Arslanian SA, LaPorte RE, Becker DJ. Changing prevalence of overweight children and adolescents at onset of insulin-treated diabetes. Diabetes Care. 2003 Oct;26(10):2871-5. doi: 10.2337/diacare.26.10.2871.'}, {'pmid': '23092524', 'type': 'BACKGROUND', 'citation': 'Kaminski BM, Klingensmith GJ, Beck RW, Tamborlane WV, Lee J, Hassan K, Schatz D, Kollman C, Redondo MJ; Pediatric Diabetes Consortium. Body mass index at the time of diagnosis of autoimmune type 1 diabetes in children. J Pediatr. 2013 Apr;162(4):736-740.e1. doi: 10.1016/j.jpeds.2012.09.017. Epub 2012 Oct 23.'}, {'pmid': '19473302', 'type': 'BACKGROUND', 'citation': 'Liu LL, Lawrence JM, Davis C, Liese AD, Pettitt DJ, Pihoker C, Dabelea D, Hamman R, Waitzfelder B, Kahn HS; SEARCH for Diabetes in Youth Study Group. Prevalence of overweight and obesity in youth with diabetes in USA: the SEARCH for Diabetes in Youth study. Pediatr Diabetes. 2010 Feb;11(1):4-11. doi: 10.1111/j.1399-5448.2009.00519.x. Epub 2009 May 15.'}, {'pmid': '22336634', 'type': 'BACKGROUND', 'citation': 'Valerio G, Iafusco D, Zucchini S, Maffeis C; Study-Group on Diabetes of Italian Society of Pediatric Endocrinology and Diabetology (ISPED). Abdominal adiposity and cardiovascular risk factors in adolescents with type 1 diabetes. Diabetes Res Clin Pract. 2012 Jul;97(1):99-104. doi: 10.1016/j.diabres.2012.01.022. Epub 2012 Feb 13.'}, {'pmid': '9669786', 'type': 'BACKGROUND', 'citation': 'Purnell JQ, Hokanson JE, Marcovina SM, Steffes MW, Cleary PA, Brunzell JD. Effect of excessive weight gain with intensive therapy of type 1 diabetes on lipid levels and blood pressure: results from the DCCT. Diabetes Control and Complications Trial. JAMA. 1998 Jul 8;280(2):140-6. doi: 10.1001/jama.280.2.140.'}, {'pmid': '20394942', 'type': 'BACKGROUND', 'citation': 'Rodriguez BL, Dabelea D, Liese AD, Fujimoto W, Waitzfelder B, Liu L, Bell R, Talton J, Snively BM, Kershnar A, Urbina E, Daniels S, Imperatore G; SEARCH Study Group. Prevalence and correlates of elevated blood pressure in youth with diabetes mellitus: the SEARCH for diabetes in youth study. J Pediatr. 2010 Aug;157(2):245-251.e1. doi: 10.1016/j.jpeds.2010.02.021. Epub 2010 Apr 14.'}, {'pmid': '19915016', 'type': 'BACKGROUND', 'citation': 'Nadeau KJ, Regensteiner JG, Bauer TA, Brown MS, Dorosz JL, Hull A, Zeitler P, Draznin B, Reusch JE. Insulin resistance in adolescents with type 1 diabetes and its relationship to cardiovascular function. J Clin Endocrinol Metab. 2010 Feb;95(2):513-21. doi: 10.1210/jc.2009-1756. Epub 2009 Nov 13.'}, {'pmid': '14514603', 'type': 'BACKGROUND', 'citation': 'Snell-Bergeon JK, Hokanson JE, Jensen L, MacKenzie T, Kinney G, Dabelea D, Eckel RH, Ehrlich J, Garg S, Rewers M. Progression of coronary artery calcification in type 1 diabetes: the importance of glycemic control. Diabetes Care. 2003 Oct;26(10):2923-8. doi: 10.2337/diacare.26.10.2923.'}, {'pmid': '19029122', 'type': 'BACKGROUND', 'citation': 'Chait A, Bornfeldt KE. Diabetes and atherosclerosis: is there a role for hyperglycemia? J Lipid Res. 2009 Apr;50 Suppl(Suppl):S335-9. doi: 10.1194/jlr.R800059-JLR200. Epub 2008 Nov 23.'}, {'pmid': '15677783', 'type': 'BACKGROUND', 'citation': 'Maahs DM, Kinney GL, Wadwa P, Snell-Bergeon JK, Dabelea D, Hokanson J, Ehrlich J, Garg S, Eckel RH, Rewers MJ. Hypertension prevalence, awareness, treatment, and control in an adult type 1 diabetes population and a comparable general population. Diabetes Care. 2005 Feb;28(2):301-6. doi: 10.2337/diacare.28.2.301.'}, {'pmid': '15855566', 'type': 'BACKGROUND', 'citation': 'Wadwa RP, Kinney GL, Maahs DM, Snell-Bergeon J, Hokanson JE, Garg SK, Eckel RH, Rewers M. Awareness and treatment of dyslipidemia in young adults with type 1 diabetes. Diabetes Care. 2005 May;28(5):1051-6. doi: 10.2337/diacare.28.5.1051.'}, {'pmid': '3113569', 'type': 'BACKGROUND', 'citation': 'Borch-Johnsen K, Kreiner S. Proteinuria: value as predictor of cardiovascular mortality in insulin dependent diabetes mellitus. Br Med J (Clin Res Ed). 1987 Jun 27;294(6588):1651-4. doi: 10.1136/bmj.294.6588.1651.'}, {'pmid': '3825934', 'type': 'BACKGROUND', 'citation': 'Krolewski AS, Kosinski EJ, Warram JH, Leland OS, Busick EJ, Asmal AC, Rand LI, Christlieb AR, Bradley RF, Kahn CR. Magnitude and determinants of coronary artery disease in juvenile-onset, insulin-dependent diabetes mellitus. Am J Cardiol. 1987 Apr 1;59(8):750-5. doi: 10.1016/0002-9149(87)91086-1.'}, {'pmid': '15467773', 'type': 'BACKGROUND', 'citation': 'Snell-Bergeon JK, Hokanson JE, Kinney GL, Dabelea D, Ehrlich J, Eckel RH, Ogden L, Rewers M. Measurement of abdominal fat by CT compared to waist circumference and BMI in explaining the presence of coronary calcium. Int J Obes Relat Metab Disord. 2004 Dec;28(12):1594-9. doi: 10.1038/sj.ijo.0802796.'}, {'pmid': '15699257', 'type': 'BACKGROUND', 'citation': 'Maahs DM, Ogden LG, Kinney GL, Wadwa P, Snell-Bergeon JK, Dabelea D, Hokanson JE, Ehrlich J, Eckel RH, Rewers M. Low plasma adiponectin levels predict progression of coronary artery calcification. Circulation. 2005 Feb 15;111(6):747-53. doi: 10.1161/01.CIR.0000155251.03724.A5. Epub 2005 Feb 7.'}, {'pmid': '12716791', 'type': 'BACKGROUND', 'citation': 'Orchard TJ, Olson JC, Erbey JR, Williams K, Forrest KY, Smithline Kinder L, Ellis D, Becker DJ. Insulin resistance-related factors, but not glycemia, predict coronary artery disease in type 1 diabetes: 10-year follow-up data from the Pittsburgh Epidemiology of Diabetes Complications Study. Diabetes Care. 2003 May;26(5):1374-9. doi: 10.2337/diacare.26.5.1374.'}, {'pmid': '15983263', 'type': 'BACKGROUND', 'citation': 'Libby P, Nathan DM, Abraham K, Brunzell JD, Fradkin JE, Haffner SM, Hsueh W, Rewers M, Roberts BT, Savage PJ, Skarlatos S, Wassef M, Rabadan-Diehl C; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation. 2005 Jun 28;111(25):3489-93. doi: 10.1161/CIRCULATIONAHA.104.529651. No abstract available.'}, {'pmid': '8640398', 'type': 'BACKGROUND', 'citation': 'Lloyd CE, Kuller LH, Ellis D, Becker DJ, Wing RR, Orchard TJ. Coronary artery disease in IDDM. Gender differences in risk factors but not risk. Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):720-6. doi: 10.1161/01.atv.16.6.720.'}, {'pmid': '14747240', 'type': 'BACKGROUND', 'citation': 'Soedamah-Muthu SS, Chaturvedi N, Toeller M, Ferriss B, Reboldi P, Michel G, Manes C, Fuller JH; EURODIAB Prospective Complications Study Group. Risk factors for coronary heart disease in type 1 diabetic patients in Europe: the EURODIAB Prospective Complications Study. Diabetes Care. 2004 Feb;27(2):530-7. doi: 10.2337/diacare.27.2.530.'}, {'pmid': '3523245', 'type': 'BACKGROUND', 'citation': 'Amiel SA, Sherwin RS, Simonson DC, Lauritano AA, Tamborlane WV. Impaired insulin action in puberty. A contributing factor to poor glycemic control in adolescents with diabetes. 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J Appl Physiol (1985). 1989 May;66(5):2239-44. doi: 10.1152/jappl.1989.66.5.2239.'}, {'pmid': '14989557', 'type': 'BACKGROUND', 'citation': 'Regensteiner JG, Popylisen S, Bauer TA, Lindenfeld J, Gill E, Smith S, Oliver-Pickett CK, Reusch JE, Weil JV. Oral L-arginine and vitamins E and C improve endothelial function in women with type 2 diabetes. Vasc Med. 2003;8(3):169-75. doi: 10.1191/1358863x03vm489oa.'}, {'pmid': '20097360', 'type': 'BACKGROUND', 'citation': 'Urbina EM, Wadwa RP, Davis C, Snively BM, Dolan LM, Daniels SR, Hamman RF, Dabelea D. Prevalence of increased arterial stiffness in children with type 1 diabetes mellitus differs by measurement site and sex: the SEARCH for Diabetes in Youth Study. J Pediatr. 2010 May;156(5):731-7, 737.e1. doi: 10.1016/j.jpeds.2009.11.011. Epub 2010 Jan 25.'}, {'pmid': '20067960', 'type': 'BACKGROUND', 'citation': 'Wadwa RP, Urbina EM, Anderson AM, Hamman RF, Dolan LM, Rodriguez BL, Daniels SR, Dabelea D; SEARCH Study Group. 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No abstract available.'}, {'pmid': '20057994', 'type': 'BACKGROUND', 'citation': 'Vella S, Buetow L, Royle P, Livingstone S, Colhoun HM, Petrie JR. The use of metformin in type 1 diabetes: a systematic review of efficacy. Diabetologia. 2010 May;53(5):809-20. doi: 10.1007/s00125-009-1636-9. Epub 2010 Jan 8.'}, {'pmid': '14514347', 'type': 'BACKGROUND', 'citation': 'Sarnblad S, Kroon M, Aman J. Metformin as additional therapy in adolescents with poorly controlled type 1 diabetes: randomised placebo-controlled trial with aspects on insulin sensitivity. Eur J Endocrinol. 2003 Oct;149(4):323-9. doi: 10.1530/eje.0.1490323.'}, {'pmid': '22540912', 'type': 'BACKGROUND', 'citation': 'TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.'}, {'pmid': '22179958', 'type': 'BACKGROUND', 'citation': 'Reinstatler L, Qi YP, Williamson RS, Garn JV, Oakley GP Jr. Association of biochemical B(1)(2) deficiency with metformin therapy and vitamin B(1)(2) supplements: the National Health and Nutrition Examination Survey, 1999-2006. Diabetes Care. 2012 Feb;35(2):327-33. doi: 10.2337/dc11-1582. Epub 2011 Dec 16.'}, {'pmid': '18721166', 'type': 'BACKGROUND', 'citation': 'Nadeau KJ, Ehlers LB, Zeitler PS, Love-Osborne K. Treatment of non-alcoholic fatty liver disease with metformin versus lifestyle intervention in insulin-resistant adolescents. Pediatr Diabetes. 2009 Feb;10(1):5-13. doi: 10.1111/j.1399-5448.2008.00450.x. Epub 2008 Aug 20.'}, {'pmid': '20393934', 'type': 'BACKGROUND', 'citation': 'Salpeter SR, Greyber E, Pasternak GA, Salpeter EE. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus. Cochrane Database Syst Rev. 2010 Apr 14;2010(4):CD002967. doi: 10.1002/14651858.CD002967.pub4.'}, {'pmid': '18779236', 'type': 'BACKGROUND', 'citation': "Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8."}, {'pmid': '20886205', 'type': 'BACKGROUND', 'citation': "Dabelea D, D'Agostino RB Jr, Mason CC, West N, Hamman RF, Mayer-Davis EJ, Maahs D, Klingensmith G, Knowler WC, Nadeau K. Development, validation and use of an insulin sensitivity score in youths with diabetes: the SEARCH for Diabetes in Youth study. Diabetologia. 2011 Jan;54(1):78-86. doi: 10.1007/s00125-010-1911-9. Epub 2010 Oct 1."}, {'pmid': '26624824', 'type': 'DERIVED', 'citation': 'Libman IM, Miller KM, DiMeglio LA, Bethin KE, Katz ML, Shah A, Simmons JH, Haller MJ, Raman S, Tamborlane WV, Coffey JK, Saenz AM, Beck RW, Nadeau KJ; T1D Exchange Clinic Network Metformin RCT Study Group. Effect of Metformin Added to Insulin on Glycemic Control Among Overweight/Obese Adolescents With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2015 Dec 1;314(21):2241-50. doi: 10.1001/jama.2015.16174.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the proposed research is to evaluate the efficacy and safety of the use of metformin in addition to standard insulin therapy in overweight and obese children and adolescents, age 12-\\<20 years, with type 1 diabetes for at least 1 year. Secondary objectives are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is still being produced by the beta cells of the pancreas, and on vascular dysfunction. In addition, an ancillary study is planned to assess if metformin will improve tissue-specific insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of presumed autoimmune type 1 diabetes (T1D) as indicated by age of diagnosis \\<10 years or documented positive diabetes-related autoantibodies.\n\n a. Note: For randomization, presence of at least one of the diabetes-related autoantibodies \\[Insulin autoantibodies (IAA) at diagnosis prior to initiation of insulin, Islet cell antibodies (ICA), Anti-GAD (GAD65), Anti-IA2 (IA2), Zinc Transporter 8 (ZnT8)\\] must be documented either from medical records or new laboratory measurement (IAA and ICA not measured by central lab) sent to central lab for participants who were ≥10 years old at diagnosis.\n2. Age: 12 to \\<20 years.\n3. Duration of type 1 diabetes: ≥1 years.\n4. Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections).\n5. Hemoglobin A1c: 7.5% - \\<10.0% from point of care measurement or local lab on day of screening visit or within 1 month prior.\n6. BMI: ≥85th percentile adjusted for age and sex .\n7. Total daily dose of insulin: ≥0.8 units per kg per day.\n8. Average of ≥3 Self-Monitoring Blood Glucose (SMBG) tests per day prior to initiating study and from download of study-provided blood glucose meter following screening visit.\n9. Available for at least 6 months of follow-up, has home phone (or access to phone), and willing to be contacted by clinical site staff.\n10. Expected to comply with protocol in investigator's judgment.\n\nExclusion Criteria:\n\n1. Use of non-insulin medications for blood glucose control within prior 6 months or planning to use within next 6 months (other than study drug).\n2. Use of medications for weight reduction (such as: Belviq (lorcaserin), Qsymia (Phentermine + topiramate), Orlistat (xenical)) within the prior 6 months or planning to use within next 6 months.\n3. Use of a medication such as stimulants, psychotropic agents and oral/inhaled glucocorticoids that could affect weight gain or glycemic control of T1D or planning to use within the next 6 months.\n4. Any condition that in the judgment of the investigator will adversely affect the completion of the protocol.\n5. Females: pregnant, lactating, or intending to become pregnant within the next 34 weeks\n\n * A negative urine pregnancy test will be required for all females An effective contraceptive method or abstinence will be required for all females who have experienced menarche\n * Requirements regarding pregnancy testing prior to enrollment and monitoring for pregnancy over the course of the study may be further defined by each individual Institutional Review Board (IRB)\n6. Clinical diagnosis of celiac disease that is in poor control as defined by most recent tissue transglutaminase (tTG) that is in the abnormal range.\n7. History of ≥1 diabetic ketoacidosis events in the past 3 months.\n8. History of ≥1 severe hypoglycemic events (cognitive impairment that required assistance to treat) in the past 3 months.\n9. History of anemia or vitamin B12 deficiency in the past 2 years.\n10. Participation in an intervention study in the past 3 months."}, 'identificationModule': {'nctId': 'NCT01881828', 'briefTitle': 'Metformin Therapy for Overweight Adolescents With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'A Randomized Trial of Metformin as Adjunct Therapy for Overweight Adolescents With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'T1DX-17-2013-506'}, 'secondaryIdInfos': [{'id': '17-2013-506', 'type': 'OTHER_GRANT', 'domain': 'JDRF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin 2000 mg per day', 'interventionNames': ['Drug: Metformin (glucophage)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral Placebo', 'description': 'A central pharmacy will compound a placebo to match the metformin tablets.\n\nThe placebo product will contain the following components:\n\n* Micosolle™, silica based excipient\n* Silicified Micro Crystalline Cellulose, National Formulary\n* Safflower Oil, United States Pharmacopeia\n* K-30 Povidone Powder\n* Magnesium Stearate, National Formulary (Vegetable source)\n* Fumed Silica, National Formulary', 'interventionNames': ['Other: oral placebo']}], 'interventions': [{'name': 'Metformin (glucophage)', 'type': 'DRUG', 'description': 'The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.', 'armGroupLabels': ['Metformin']}, {'name': 'oral placebo', 'type': 'OTHER', 'armGroupLabels': ['Oral Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33647', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Jaeb Center for Health Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Kellee Miller, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jaeb Center for Health Research'}, {'name': 'Ingrid Libman, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Childrens Hospital of University of Pittsburgh Medical Center'}, {'name': 'Kristen Nadeau, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado Denver/Childrens Hospital Colorado'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}