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)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: MK-1293; EU-Lantus™; Novolog™
Intervention description: MK-1293 0.4 units/kg administered subcutaneously; EU-Lantus™ 0.4 units/kg administered subcutaneously; Participants will receive an intravenous infusion of insulin aspart (Novolog™ or other rapid-acting insulin analog) for several hours prior to MK-1293 or EU-Lantus™ dosing in each dosing period to meet basal insulin requirements
Intervention MeSH terms: Insulin Aspart; MK-1293
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility 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.