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NCT03095651 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT03095651: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT03095651 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03095651, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This is a two-part trial, with three panels per part. T1DM (Part 1) and T2DM (Part 2) participants will be given daily fixed doses of MK-5160 in three predefined, increasing doses in each panel, or glargine (active comparator). The primary hypothesis of the trial is that at a dose with sufficient safety, the mean steady-state maximum level of glucose infusion rate (GIRmax) after MK-5160 administration in both T1DM and T2DM participants is between 1.5 and 4.5 mg/kg/min.
Primary Outcome
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Interventions
- BIOLOGICAL MK-5160 16 nmol/kg
- BIOLOGICAL MK-5160 32 nmol/kg
- BIOLOGICAL MK-5160 64 nmol/kg
- BIOLOGICAL Glargine 0.4 U/kg
- BIOLOGICAL Placebo to Glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-04-12 |
| Est. Completion | 2018-01-30 |
| Phase | Phase 1 |
What the finished NCT03095651 record still lists
NCT03095651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 5 interventions - of which MK-5160 16 nmol/kg is the first listed.
NCT03095651 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03095651 about?
NCT03095651 is a clinical study titled "Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)". This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This is a two-part trial, with three panels per part. T1DM (Part 1) and T2DM (Part 2) participants will be given daily fixed d...
What is the current status of trial NCT03095651?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2017-04-12. Estimated completion is 2018-01-30.
What interventions are being tested in trial NCT03095651?
The interventions under investigation include: MK-5160 16 nmol/kg (BIOLOGICAL), MK-5160 32 nmol/kg (BIOLOGICAL), MK-5160 64 nmol/kg (BIOLOGICAL), Glargine 0.4 U/kg (BIOLOGICAL), Placebo to Glargine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03095651?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03095651's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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