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

Exclusion Criteria

• •All participants
• •Is mentally or legally incapacitated
• •Has a history of clinically significant endocrine (excluding diabetes mellitus in Part 3 participants), gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases.
• •Has a systolic blood pressure (SBP) ≥140 mm Hg and/or a diastolic blood pressure (DBP) ≥90 mm Hg at screening.
• •Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) at screening.
• •Has a history of cancer (malignancy) Exceptions: (1) Participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) Participants with other malignancies which have been successfully treated ≥10 years prior to the pretrial (screening) visit
• •Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
• •Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial (screening) visit.
• •Has participated in another investigational trial within 4 weeks.
• •Has been randomized to, and received MK-5160 in prior clinical studies.
• •Has a QTcF interval \>450 msec, has a history of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of Long QT Syndrome).
• •Has uncorrected hypokalemia
• •Has uncorrected hypomagnesemia
• •Is taking concomitant medications that prolong the QT/QTc interval.
• •Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks prior to administration of the initial dose of trial drug, throughout the trial, until the post-trial visit.
• •Has had a vaccination within 12 weeks of the pretrial visit.
• •Consumes greater than 3 glasses of alcoholic beverages per day.
• •Consumes excessive amounts, defined as greater than 6 servings caffeinated beverages per day.
• •Is currently a regular or recreational user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months
• •Has used systemic (intravenous, oral, inhaled) glucocorticoids within 3 months of screening or is anticipated to require treatment with systemic glucocorticoids during study participation.
• •For Part 1 and Part 2 (Healthy Adult Participants)
• •\- Has an estimated creatinine clearance of \<90 mL/min based on Cockcroft-Gault equation
• •For Part 3 (Adult participants with T1DM):
• •Has a history of diabetic ketoacidosis in the last 6 months prior to screening.
• •Has an estimated creatinine clearance of \<60 mL/min based on the Cockcroft-Gault equation at screening
• •Has the diagnosis of hypoglycemia unawareness, or has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 6 months prior to dosing.
• •Has other major medical problems requiring medication (i.e., history of myocardial infarction (MI), hypercholesterolemia).
• •Has a known history of celiac disease or significant food allergy, at the discretion of the investigator and Sponsor.
• •Has a history of hypersensitivity to pharmacologic insulins or to any of the inactive ingredients in recombinant human insulin, or to any E.coli-derived drug product.
• •For Part 4 (Adult participants with T2DM):
• •Participant has an estimated creatinine clearance of \<60 mL/min based on the Cockcroft-Gault equation.
• •Has a history of diabetic ketoacidosis in the last 6 months prior to screening.
• •Has the diagnosis of hypoglycemia unawareness, or has had one or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within 6 months prior to dosing.
• •Has a known history of celiac disease or significant food allergy, at the discretion of the Investigator and Sponsor.
• •Has been treated with a thiazolidinedione or injectable non-insulin anti-diabetic therapy within the past three months prior to dosing.
• •Has a history of hypersensitivity to pharmacologic insulins or to any of the inactive ingredients in regular human insulin, or to any E.coli-derived drug product.