At a glance
ClinicalIndex Comparison Record- ✓Healthy males or non-child-bearing females (Parts 1–2), or males/non-child-bearing females aged 18–60 with T1DM or T2DM (Parts 3–4)
- ✓For healthy participants (Parts 1–2): age 18–50 years, BMI 18.5–28.0 kg/m², fasting blood glucose <100 mg/dL
- ✓For T1DM participants (Part 3): T1DM diagnosis ≥12 months, BMI 18.5–32 kg/m², stable basal insulin doses for 2 weeks prior to screening and dosing, total daily insulin ≤1.2 units/kg, HbA1c ≤10%, serum C-peptide ≤0.7 ng/mL with concurrent plasma glucose >90 mg/dL at screening or within 24 weeks prior
- ✓For T2DM participants (Part 4): T2DM diagnosis ≥12 months, BMI 18.5–35.0 kg/m², HbA1c 6.5–10.0%; if on insulin, total daily dose ≤1.2 units/kg and stable for 2 weeks prior to screening and dosing
- ✕History of clinically significant endocrine (except diabetes in Part 3), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- ✕Systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg at screening
- ✕Positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV at screening
- ✕History of cancer (malignancy) except adequately treated non-melanomatous skin carcinoma, carcinoma in situ of the cervix, or other malignancies successfully treated ≥10 years prior to screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating MK-1092, 4.0 nmol/kg, MK-1092, 8.0 nmol/kg, and 9 other interventions for Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. Completed, enrolled 69 participants across 1 site.
Detailed 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)
Study Details
Timeline
Interventions
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.