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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 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 33 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03095651
The ClinicalTrials.gov registry entry for NCT03095651 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which MK-5160 16 nmol/kg is the first listed.
NCT03095651 reports 0 study locations.
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.
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