A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1293 Compared With a Basal Insulin in Participants With Type 1 Diabetes (MK-1293-005)

• Status: Completed
• Trial end date: 2015-04-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, pharmacokinetics, and pharmacodynamics of MK-1293 compared with a basal insulin (EU-Lantus™) in participants with Type 1 Diabetes. The primary hypotheses are that the duration of action, pharmacodynamic profile, and pharmacokinetic profile of MK-1293 and the comparator basal insulin are similar.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Insulin; Insulin Aspart; Insulin Glargine; MK-1293

Criteria

Inclusion Criteria:

• Has type 1 diabetes mellitus diagnosed at least 12 months before screening

• Subject to investigator discretion, is on a stable dose of insulin for at least 2 weeks before screening

• Has a total daily insulin dose <=1.2 units/kg

• Has a screening hemoglobin A1c <9.5%

• Has a body mass index >18.0 and <=30.0 kg/m^2

• Has a weight >=50 kg

• Female participant of reproductive potential has a serum beta-human chorionic gonadotropin level consistent with the nongravid state and agrees to use (and/or have her partner use) 2 acceptable methods of birth control until 2 weeks after the last dose of study drug

• Postmenopausal female participant is without menses for >=1 year

• Surgically sterile female participant status is post hysterectomy, oophorectomy, or tubal ligation

• Has not used nicotine or nicotine-containing products for at least 3 months before study start or smokes less than 10 cigarettes per day and is willing to abstain during the trial

Exclusion Criteria:

• Has a history of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease

• Has a history of clinically significant endocrine abnormalities or diseases except type 1 diabetes mellitus

• Has had any severe hypoglycemic episodes associated with hypoglycemic seizures, comas, or unconsciousness within the past 3 months

• Has a history of diabetic ketoacidosis within the past 6 months

• Has a history of significant multiple or severe allergies, anaphylactic reaction, or significant intolerability to drugs or food

• Has a history of hypersensitivity to pharmacologic insulins

• Is positive for hepatitis B surface antigen, hepatitis C, or Human Immunodeficiency Virus

• Has had major surgery or donated or lost 1 unit of blood within 4 weeks before screening

• Unable to refrain from use of any medication or herbal remedy from 2 weeks prior to the first dose of study drug to until the posttrial visit. Some medications are permitted and may be discussed with the investigators

• Vaccination within 12 weeks of start of study participation

• Consumes >3 glasses of alcoholic beverages per day. Participants consuming 4 glasses of alcoholic beverages may be enrolled at the discretion of the investigator.

• Consumes >6 servings of caffeinated beverages per day

• Is a regular user of any illicit drugs or has a history of drug abuse (including alcohol) within approximately 1 year

• Is on a carbohydrate-restricted diet (<100 grams carbohydrate per day); participants who are on a carbohydrate-restricted diet may be included if they agree to a diet consisting of >=100 grams of carbohydrate daily throughout the study

• Has a personal or family history of hypercoagulability or thromboembolic disease

• Has used systemic glucocorticoids within 3 months of screening or anticipates treatment with systemic glucocorticoids during study participation.