NCT04409795

Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study

A Pilot Trial of Adding Oral Hypoglycemic Therapy to Insulin Treatment in Monogenic Variant Carriers of the Joslin 50-Year Medalist Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Joslin Diabetes Center · Academic / Other
• Sex: All
• Age: 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 1 Diabetes
• Monogenic Diabetes

Interventions

Type	Name	Description
DRUG	Metformin Extended Release Oral Tablet	Initial oral hypoglycemic agent added to existing insulin treatment
DRUG	Sitagliptin	Secondary oral hypoglycemic agent added to existing insulin treatment (for those who are intolerant to or unable to achieve glycemic targets with metformin)

Timeline

• Start date: 2021-08-26
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-06-01
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study