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

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)

Conditions

• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Interventions

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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Principal Investigators

• Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-16

Primary Completion

2018-11-08

Completion

2018-11-08

FDA Drug

Yes

Countries

• United States

Study Locations