Phase 1
Completed N=76
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)
Source: ClinicalTrials.gov NCT02059174 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Comparison of MK-1293 and EU-Approved Lantus Duration of Pharmacodynamic Action During a 30-Hour Euglycemic Clamp Study — 30; 30 Hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of MK-1293 and EU-Approved Lantus Duration of Pharmacodynamic Action During a 30-Hour Euglycemic Clamp Study |
30; 30 | — |
| PRIMARY PD: Area Under the Glucose Infusion Rate Versus Time Curve Over 24 Hours After Dosing (GIR-AUC0-24hr) |
1470.07; 1554.53 | — |
| PRIMARY PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the First 12 Hours After Dosing (GIR-AUC0-12hr) |
659.38; 736.31 | — |
| PRIMARY PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the Second 12 Hours After Dosing (GIR-AUC12-24hr) |
811.43; 818.20 | — |
| PRIMARY PD: Maximum Glucose Infusion Rate (GIRmax) |
2.34; 2.43 | — |
| PRIMARY M1 Glargine Metabolite Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC0-24) |
6530; 6763 | — |
| PRIMARY M1 Glargine Metabolite PK: Maximum Plasma Concentration (Cmax) |
372; 382 | — |
| SECONDARY M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the First 12 Hours After Dosing (AUC0-12) |
2981; 3251 | — |
| SECONDARY M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the Second 12 Hours After Dosing (AUC12-24) |
3510; 3522 | — |
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 18.0 and =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.
Data sourced from ClinicalTrials.gov (NCT02059174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.