NCT03170544

Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)

A Single Ascending Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1092 in Healthy Subjects, Subjects With Type 1 Diabetes Mellitus, and Subjects With Type 2 Diabetes Mellitus.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is an active- and placebo-controlled, single-site, four-part trial of MK-1092 in healthy adult participants, in participants with type 1 diabetes mellitus (T1DM), and in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis for this study is that at a dose with sufficient safety, the mean maximal glucose infusion rate (GIRmax) after single subcutaneous (SC) administration of MK-1092 in adult participants with T1DM is within an acceptable range. (Part 3)

Detailed description

There will be 4 parts in this study. In Part 1, healthy adult participants will be randomized to receive blinded MK-1092 subcutaneously (SC) or glargine SC, as a single dose under the euglycemic clamp. Once a safe and tolerated dose that achieves GIRmax is identified in Part 1, Part 2 will start. In Part 2, 4 different healthy adult participants will be enrolled in a single panel and receive open-label MK-1092 SC as a single dose under the euglycemic clamp and also receive an intravenous infusion of Humalog®. In Part 3, adult participants with T1DM will be randomized to receive blinded MK-1092 SC or insulin glargine SC, as a single dose under the euglycemic clamp. Part 4 includes a 3-period (Periods 1, 2, and 3) design that will explore up to 3 single subcutaneous doses of MK-1092 or insulin glargine in participants with Type 2 diabetes mellitus.

Conditions

• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	MK-1092, 4.0 nmol/kg	MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
DRUG	MK-1092, 8.0 nmol/kg	MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
DRUG	MK-1092, 16 nmol/kg	MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
DRUG	MK-1092, 32 nmol/kg	MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
DRUG	MK-1092, 64 nmol/kg	MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
DRUG	Glargine 3.0 nmol/kg	Glargine 3.0 nmol/kg, SC, as a single dose
DRUG	Lispro 1.2 nmol/kg	Lispro (Humalog®), 1.2 nmol/kg, IV infusion SC over 3 hours as a single dose starting \~12 hours after MK-1092 administration.
DRUG	Placebo to glargine	Placebo to glargine, SC, as a single dose
DRUG	Placebo to MK-1092	Placebo to MK-1092, SC, as a single dose
OTHER	Dextrose	20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
BIOLOGICAL	Insulin	Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.

Timeline

• Start date: 2017-08-16
• Primary completion: 2018-11-08
• Completion: 2018-11-08
• First posted: 2017-05-31
• Last updated: 2019-11-15
• Results posted: 2019-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study