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NCT04409795 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Joslin Diabetes Center.

Completed
Registry status
Phase 2
Development phase
3
Enrollment target

NCT04409795: Completed Phase 2 study, sponsored by Joslin Diabetes Center.

NCT04409795 is a Phase 2 study that has completed, run by Joslin Diabetes Center. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04409795, a Phase 2 study, has completed, sponsored by Joslin Diabetes Center.

COMPLETED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study 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.

Primary Outcome

Change in HbA1c (%) between the two study groups

Interventions

  • DRUG Sitagliptin
  • DRUG Metformin Extended Release Oral Tablet

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2021-08-26
Est. Completion 2024-12-31
Phase Phase 2
Joslin Diabetes Center

73 total trials

What the finished NCT04409795 record still lists

NCT04409795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Sitagliptin is the first listed.

NCT04409795 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04409795 about?

NCT04409795 is a clinical study titled "Oral Hypoglycemic Therapy for Monogenic Variant Carriers of the Joslin Medalist Study". 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...

What is the current status of trial NCT04409795?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2021-08-26. Estimated completion is 2024-12-31.

What interventions are being tested in trial NCT04409795?

The interventions under investigation include: Sitagliptin (DRUG), Metformin Extended Release Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT04409795?

This trial is sponsored by Joslin Diabetes Center, which has 73 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04409795's enrollment target sits among peer trials

3 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04409795, the US trial registry maintained by the National Library of Medicine. NCT04409795 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.