| Trial ID: | L3951 |
| Source ID: | NCT04409795
|
| Associated Drug: |
Metformin Extended Release Oral Tablet
|
| Title: |
Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes|Monogenic Diabetes
|
| Interventions: |
DRUG: Metformin Extended Release Oral Tablet|DRUG: Sitagliptin
|
| Outcome Measures: |
Primary: Glycated hemoglobin (HbA1c), Change in HbA1c (%) between the two study groups, 3 months and 6 months | Secondary: Daily insulin dose, Change in daily insulin dose (units/kg body weight) between the two study groups, 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., 3 months and 6 months|C-peptide, Change in C-peptide (ng/mL) between the two study groups, 3 months and 6 months|Total cholesterol, Change in total cholesterol (mg/dL) between the two study groups, 3 months and 6 months|Low density lipoprotein (LDL)-cholesterol, Change in LDL-cholesterol (mg/dL) between the two study groups, 3 months and 6 months|High density lipoprotein (HDL)-cholesterol, Change in HDL-cholesterol (mg/dL) between the two study groups, 3 months and 6 months|Triglycerides, Change in triglycerides (mg/dL) between the two study groups, 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, 6 months
|
| Sponsor/Collaborators: |
Sponsor: Joslin Diabetes Center
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
3
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-08-26
|
| Completion Date: |
2024-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-24
|
| Locations: |
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04409795
|
