Single Ascending Dose Study of MK-1092 in Healthy Participants and in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-1092-001)
Condition: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): MK-1092, 4.0 nmol/kg; MK-1092, 8.0 nmol/kg; MK-1092, 16 nmol/kg; MK-1092, 32 nmol/kg; MK-1092, 64 nmol/kg; Glargine 3.0 nmol/kg; Lispro 1.2 nmol/kg; Placebo to glargine; Placebo to MK-1092; Dextrose; Insulin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Other; Biological
Intervention description(s): MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants; MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants; MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants; MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants; MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants; Glargine 3.0 nmol/kg, SC, as a single dose; Lispro (Humalog®), 1.2 nmol/kg, IV infusion SC over 3 hours as a single dose starting ~12 hours after MK-1092 administration.; Placebo to glargine, SC, as a single dose; Placebo to MK-1092, SC, as a single dose; 20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.; Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
Other intervention name(s): Humalog®; Glucose
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment