Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT00835861
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2009-02-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D007328', 'term': 'Insulin'}, {'id': 'D007336', 'term': 'Insulin, Isophane'}, {'id': 'D000068880', 'term': 'Isophane Insulin, Human'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061386', 'term': 'Insulin, Regular, Human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.ashley.hickman@gmail.com', 'phone': '469-303-3591', 'title': 'M. Ashley Hickman Zink', 'organization': 'Maternal-Fetal Medicine and Obstetrics at UT Southwestern'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Unable to achieve enrollment goal before funding period expired because recruitment progressed more slowly than anticipated.'}}, 'adverseEventsModule': {'timeFrame': 'From July 2008 through March 2010', 'eventGroups': [{'id': 'EG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Intrauterine fetal demise', 'notes': 'In the metformin group, one woman experienced a 13-week intrauterine fetal demise attributed to a large subchorionic hematoma noted on ultrasound at 12 weeks.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Glucose Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'title': 'Fasting throughout enrollment', 'categories': [{'measurements': [{'value': '97.38', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '101'}, {'value': '95.04', 'groupId': 'OG001', 'lowerLimit': '86', 'upperLimit': '115'}]}]}, {'title': 'Fasting 18-20 weeks', 'categories': [{'measurements': [{'value': '97.00', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '100'}, {'value': '92.38', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '116'}]}]}, {'title': 'Fasting 28-30 weeks', 'categories': [{'measurements': [{'value': '92.43', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '98'}, {'value': '90.64', 'groupId': 'OG001', 'lowerLimit': '84', 'upperLimit': '106'}]}]}, {'title': 'Fasting 36-38 weeks', 'categories': [{'measurements': [{'value': '89.49', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '96'}, {'value': '85.18', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '107'}]}]}, {'title': 'Postprandial throughout enrollment', 'categories': [{'measurements': [{'value': '120.40', 'groupId': 'OG000', 'lowerLimit': '115', 'upperLimit': '129'}, {'value': '128.62', 'groupId': 'OG001', 'lowerLimit': '115', 'upperLimit': '143'}]}]}, {'title': 'Postprandial 18-20 weeks', 'categories': [{'measurements': [{'value': '118.40', 'groupId': 'OG000', 'lowerLimit': '107', 'upperLimit': '122'}, {'value': '120.46', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': '142'}]}]}, {'title': 'Postprandial 28-30 weeks', 'categories': [{'measurements': [{'value': '119.00', 'groupId': 'OG000', 'lowerLimit': '114', 'upperLimit': '125'}, {'value': '126.45', 'groupId': 'OG001', 'lowerLimit': '115', 'upperLimit': '137'}]}]}, {'title': 'Postprandial 36-38 weeks', 'categories': [{'measurements': [{'value': '122.59', 'groupId': 'OG000', 'lowerLimit': '118', 'upperLimit': '130'}, {'value': '125.25', 'groupId': 'OG001', 'lowerLimit': '112', 'upperLimit': '138'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery', 'description': 'Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'For 1 infant in each group, the initial neonatal glucose value was missing.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Obstetric Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout pregnancy until hospital discharge following delivery.', 'description': 'Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Weight Gain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.38'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline throughout pregnancy until last prenatal visit.', 'unitOfMeasure': 'kg/week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Babies With Neonatal Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time of delivery through hospital discharge', 'description': 'Initial neonatal glucose \\< 40 mg/dL', 'unitOfMeasure': 'Number of babies', 'reportingStatus': 'POSTED', 'populationDescription': 'For 1 infant in each group, the initial neonatal glucose value was missing.'}, {'type': 'SECONDARY', 'title': 'Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'title': '1st trimester', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '6.5'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '7.5'}]}]}, {'title': '2nd trimester', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '5.8'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '6.1'}]}]}, {'title': '3rd trimester', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '6.0'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '6.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1st, 2nd, and 3rd trimester', 'unitOfMeasure': 'percentage of glycosolated hemoglobin', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'title': 'Throughout enrollment; n=1634, 1432', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.67'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.81'}]}]}, {'title': '18-20 weeks; n=148, 259', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '0.57'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.83'}]}]}, {'title': '28-30 weeks; n=253, 201', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.85'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '0.23', 'upperLimit': '1.00'}]}]}, {'title': '36-38 weeks; n=115, 83', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.93'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '1.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline throughout pregnancy until time of delivery', 'description': 'NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES \\<95', 'unitOfMeasure': 'percent of glucose values', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'title': 'Throughout enrollment; n=4195, 3796', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': '18-20 weeks; n=368, 428', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}, {'title': '28-30 weeks; n=652, 559', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': '36-38 weeks; n=272,228', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline throughout pregnancy until time of delivery', 'description': 'NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES \\<130', 'unitOfMeasure': 'percent of glucose values', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Episodes Maternal Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline throughout pregnancy until time of delivery', 'description': 'Maternal glucose \\< 60 mg/dL', 'unitOfMeasure': 'Number of episodes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Babies With Adverse Neonatal Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin', 'description': 'Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values \\<90 mg/dL and 1-hr post prandial values \\< 130 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Delivery until hospital discharge', 'description': 'Resuscitation in the delivery room, preterm birth \\< 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.', 'unitOfMeasure': 'number of babies', 'reportingStatus': 'POSTED', 'populationDescription': 'For 1 infant in the metformin group, the "adverse neonatal outcome" data was missing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin', 'description': 'Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone'}, {'id': 'FG001', 'title': 'Insulin', 'description': 'Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and neutral protamine Hagedorn (NPH) insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values \\<90 and one hour post prandial values \\<130.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Recruitment occurred at two hospitals from July 2008 through March 2010 at one and from January 2009 through December 2009 at the other.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metformin', 'description': 'Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone.'}, {'id': 'BG001', 'title': 'Insulin', 'description': 'Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values \\<90 and one hour post prandial values \\<130.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '32.7', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Three women who never received the allocated treatment were excluded from the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2009-02-02', 'resultsFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2009-02-02', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-24', 'studyFirstPostDateStruct': {'date': '2009-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Glucose Measurements', 'timeFrame': 'Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery', 'description': 'Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Obstetric Complications', 'timeFrame': 'Throughout pregnancy until hospital discharge following delivery.', 'description': 'Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.'}, {'measure': 'Maternal Weight Gain', 'timeFrame': 'Baseline throughout pregnancy until last prenatal visit.'}, {'measure': 'Number of Babies With Neonatal Hypoglycemia', 'timeFrame': 'Time of delivery through hospital discharge', 'description': 'Initial neonatal glucose \\< 40 mg/dL'}, {'measure': 'Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester', 'timeFrame': '1st, 2nd, and 3rd trimester'}, {'measure': 'Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)', 'timeFrame': 'Baseline throughout pregnancy until time of delivery', 'description': 'NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES \\<95'}, {'measure': 'Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)', 'timeFrame': 'Baseline throughout pregnancy until time of delivery', 'description': 'NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES \\<130'}, {'measure': 'Number of Episodes Maternal Hypoglycemia', 'timeFrame': 'Baseline throughout pregnancy until time of delivery', 'description': 'Maternal glucose \\< 60 mg/dL'}, {'measure': 'Number of Babies With Adverse Neonatal Outcomes', 'timeFrame': 'Delivery until hospital discharge', 'description': 'Resuscitation in the delivery room, preterm birth \\< 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non Insulin Dependent Diabetes', 'Pregnancy'], 'conditions': ['Non Insulin Dependent Diabetes', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '23096052', 'type': 'DERIVED', 'citation': 'Hickman MA, McBride R, Boggess KA, Strauss R. Metformin compared with insulin in the treatment of pregnant women with overt diabetes: a randomized controlled trial. Am J Perinatol. 2013 Jun;30(6):483-90. doi: 10.1055/s-0032-1326994. Epub 2012 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.\n\nOur goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital\n* Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control\n* Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria\n* Less than 24 weeks at study enrollment\n* Singleton or twin pregnancy\n* English or Spanish speaking\n* Able to give informed consent\n\nExclusion Criteria:\n\n* End organ complications of diabetes (retinopathy, renal insufficiency, etc.)\n* Prior need for insulin for glycemic control\n* History of diabetic ketoacidosis (DKA) or hyperosmolar state\n* Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin\n* Kidney or liver disease\n* Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded."}, 'identificationModule': {'nctId': 'NCT00835861', 'acronym': 'MIPOD', 'briefTitle': 'Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Pilot Study of Metformin vs. Insulin in Pregnant Overt Diabetics (MIPOD)', 'orgStudyIdInfo': {'id': 'UNC08-0898'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin', 'description': 'Women who enter pregnancy with a diagnosis of non insulin dependent/Type 2 Diabetes that is controlled with diet or an oral hypoglycemic agent, and women who demonstrate abnormal glucose tolerance prior to 20 weeks of gestation by abnormal 3 hour glucose challenge testing will be offered study participation. After informed consent, they will be randomized 1:1 to either the Metformin or Insulin group.', 'interventionNames': ['Drug: Insulin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Women randomized to the Experimental arm will receive standard diet and glucose self-monitoring education. They will be initiated on Metformin 500 BID if they were medication naïve, or will be continued on their current dosage of Metformin if they were taking it prior to pregnancy. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to a maximum of 2250mg/day to achieve target glycemic control. If glycemic control can not be achieved with Metformin as a single agent insulin will be added.', 'armGroupLabels': ['Metformin']}, {'name': 'Insulin', 'type': 'DRUG', 'otherNames': ['Regular Insulin', 'Novolin R', 'Humulin R', 'NPH Insulin', 'Novolin N', 'Humulin N'], 'description': 'Women randomized to the Insulin group will receive standard diet and glycemic monitoring education. They will be initiated on weight based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular)administered with dinner. At each clinic visit fasting and one hour post prandial glucose values will be reviewed, and dosage will be titrated to achieve optimal glycemic control with fasting values \\<90 and one hour post prandial values \\<130.', 'armGroupLabels': ['Insulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospitals Obstetric Clinics', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Ashley Hickman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'WakeMed Health and Hospitals', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}