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)

Conditions: Type 1 Diabetes Mellitus

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 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.