drugset / Trial / NCT03095651
Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2017-04-12
- Primary completion
- 2018-01-30
- Completion
- 2018-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-5160 | Unknown | 16 unknown | Subcutaneous |
| Subject | MK-5160 | Unknown | 32 unknown | Subcutaneous |
| Subject | MK-5160 | Unknown | 64 unknown | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.4 iu/kg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.6 iu/kg | Subcutaneous |
| Background | Dextrose | Unknown | — | Intravenous |