A Phase 2/3 interventional study of Metformin Extended Release Oral Tablet and Sitagliptin in Type 1 Diabetes and Monogenic Diabetes, sponsored by Joslin Diabetes Center. Completed at 1 site in United States. Open to participants aged Up to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Joslin Diabetes Center · Phase 2/3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of adding oral hypoglycemic agents (OHA) to existing insulin treatment in monogenic variant carriers of the Joslin 50-Year Medalist Study ("Medalists"), who are characterized by ≥50 years of insulin-dependent diabetes. Our primary objective is to evaluate whether the presence of human leukocyte antigen (HLA) high-risk alleles for diabetes (DR3 and/or DR4) can affect the effectiveness of OHA in these subjects.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 3 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Joslin Diabetes Center is the lead sponsor of 79 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who are high-risk HLA-DR3 and/or DR4 (+); monogenic variant (+) with rare exome variant ensemble learner (REVEL) score\>0.75; and both glutamic acid decarboxylase (GAD65) and islet antigen (IA2) autoantibody (-)
Drug: Metformin Extended Release Oral Tablet · Drug: Sitagliptin
Participants who are high-risk HLA-DR3 and DR4 (-); with known or yet unknown monogenic variants with REVEL score\>0.75; and either GAD65 and IA2 autoantibody (-), or autoantibody (+) with titers close to the cutoff
Drug: Metformin Extended Release Oral Tablet · Drug: Sitagliptin
Initial oral hypoglycemic agent added to existing insulin treatment
Secondary oral hypoglycemic agent added to existing insulin treatment (for those who are intolerant to or unable to achieve glycemic targets with metformin)
Glycated hemoglobin (HbA1c)
Change in HbA1c (%) between the two study groups
Time frame: 3 months and 6 months
Daily insulin dose
Change in daily insulin dose (units/kg body weight) between the two study groups
Time frame: 3 months and 6 months
Body mass index (BMI)
Change in BMI between the two study groups. Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 3 months and 6 months
C-peptide
Change in C-peptide (ng/mL) between the two study groups
Time frame: 3 months and 6 months
Total cholesterol
Change in total cholesterol (mg/dL) between the two study groups
Time frame: 3 months and 6 months
Low density lipoprotein (LDL)-cholesterol
Change in LDL-cholesterol (mg/dL) between the two study groups
Time frame: 3 months and 6 months
High density lipoprotein (HDL)-cholesterol
Change in HDL-cholesterol (mg/dL) between the two study groups
Time frame: 3 months and 6 months
Triglycerides
Change in triglycerides (mg/dL) between the two study groups
Time frame: 3 months and 6 months
Area under the plasma concentration versus time curve (AUC) of C-peptide
Change in AUC of C-peptide between the two study groups, as measured by the hyperglycemic/arginine clamp, at the end of the study
Time frame: 6 months
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Joslin Diabetes Center