Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-02-21 @ 10:12 PM
Study NCT ID:
NCT01741103
Status:
WITHDRAWN
Last Update Posted:
2022-03-24
First Post:
2011-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sitagliptin in Type I Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': "Study funding was for 1 year to a fellow who graduated in early stages of enrollment. While 6 patients were enrolled, many patients didn't finish the study and therefore little data was collected and no results will be entered.", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2011-09-27', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in mean glucose concentrations', 'timeFrame': 'baseline and 3 months', 'description': 'The primary endpoint of the study is to detect the change from baseline in mean glucose concentrations as measured by both HbA1c, and mean glucose over the three days of continuous glucose monitoring.'}], 'secondaryOutcomes': [{'measure': 'Glycemic changes', 'timeFrame': 'baseline and 3 months', 'description': 'Glycemic changes including standard deviations of the glycemic levels, fructosamine, and the duration of time spent in hyperglycemia and hypoglycemia.'}, {'measure': 'Post meal hyperglycemia', 'timeFrame': 'baseline and 3 months', 'description': 'Post meal hyperglycemia will be measured as area under the curve (AUC).'}, {'measure': 'Changes in post prandial glucose, glucagon, insulin, c-peptide, DPP-IV, GIP and, GLP-1 concentrations following meal challenge.', 'timeFrame': 'baseline and 3 months'}, {'measure': 'Changes in NF kappa B in the fasting state.', 'timeFrame': 'baseline and 3 months'}, {'measure': 'Change in NFkappaB following meal challenge.', 'timeFrame': 'baseline and 3 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Type I']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effect of sitagliptin on overall blood glucose concentrations in Type I Diabetic subjects. The study also aims to evaluate post meal glucagon concentrations in Type I Diabetic subjects (a possible mechanism of reduced blood glucose concentrations) and indices of oxidation stress in the plasma of these subjects.', 'detailedDescription': 'The hypothesis is that Sitagliptin will improve overall blood glucose, fasting blood glucose, and glycemic excursions in patients with Type I Diabetes. In addition, sitagliptin will likely suppress indices of oxidative stress in patients. The study will investigate proposed mechanisms of improved glucose concentrations, including enhanced effect of endogenous GLP-1 and suppression of glucagon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female adult, aged 18 to 70 years\n2. Type 1 Diabetes Mellitus for 6 months or more, as established by medical history\n3. Current treatment with multiple injections of insulin (at least 4) or CSII (continuous subcutaneous insulin infusion or insulin pump) therapy for at least 3 months prior to screening visit; and using the same insulin during the last 1 month\n4. HbA1c ≤ 8.5%\n5. Subjects should routinely practice at least 2-4 blood glucose measurements per day\n6. BMI ≤ 35 kg/m2\n7. Subject must be able and willing to perform self-blood glucose monitoring and accept wearing a continuous glucose monitor for 3 days at the start and 3 days at the end of the study\n8. Subjects must be willing to complete study visits per study protocol\n9. Able to speak, read, and write English\n\nExclusion Criteria:\n\n1. Type 1 Diabetes Mellitus for less than 6 months\n2. Coronary Event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery, or coronary angioplasty) in the previous 4 weeks\n3. Any other life-threatening, non-cardiac disease\n4. Pregnant or intends to become pregnant during the course of the study\n5. Severe unexplained hypoglycemia that required emergency treatment over the past 3 months\n6. History of hemoglobinopathies\n7. Post-renal transplantation, currently undergoing dialysis, creatinine of \\>1.5mg/dl or a calculated creatinine clearance of \\<50 mL/min.\n8. Have extensive skin changes/diseases that inhibit wearing the sensor on normal skin\n9. Subjects who have an allergy to medication being used\n10. Current participation in another study protocol\n11. History of autonomic neuropathy or gastroparesis'}, 'identificationModule': {'nctId': 'NCT01741103', 'briefTitle': 'Sitagliptin in Type I Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University at Buffalo'}, 'officialTitle': 'Effect of Sitagliptin on Glycemic Control, Post-prandial Glucagon, and Inflammation in Type 1 Diabetics', 'orgStudyIdInfo': {'id': '1957'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin', 'interventionNames': ['Drug: sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia/Sitagliptin 100mg'], 'description': 'sitagliptin 100mg by mouth once a day for 12 weeks', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Take one by mouth daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': '115 Flint Road', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}], 'overallOfficials': [{'name': 'Paresh Dandona, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaleida Health and University at Buffalo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor of Medicine', 'investigatorFullName': 'Paresh Dandona', 'investigatorAffiliation': 'Kaleida Health'}}}}