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)

NCT ID: NCT02059174

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-10
• Study Completion Date: 2015-04-27

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MK-1293 / EU-Lantus™ / MK-1293 / EU-Lantus™

MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period

Group Type: EXPERIMENTAL

MK-1293

Intervention Type: DRUG

MK-1293 0.4 units/kg administered subcutaneously

EU-Lantus™

Intervention Type: DRUG

EU-Lantus™ 0.4 units/kg administered subcutaneously

Novolog™

Intervention Type: DRUG

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

EU-Lantus™ / MK-1293 / EU-Lantus™ / MK-1293

MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period

Group Type: EXPERIMENTAL

MK-1293

Intervention Type: DRUG

MK-1293 0.4 units/kg administered subcutaneously

EU-Lantus™

Intervention Type: DRUG

EU-Lantus™ 0.4 units/kg administered subcutaneously

Novolog™

Intervention Type: DRUG

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

Interventions

MK-1293

MK-1293 0.4 units/kg administered subcutaneously

Intervention Type: DRUG

EU-Lantus™

EU-Lantus™ 0.4 units/kg administered subcutaneously

Intervention Type: DRUG

Novolog™

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 Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Crutchlow MF, Palcza JS, Mostoller KM, Mahon CD, Barbour AM, Marcos MC, Xu Y, Watkins E, Morrow L, Hompesch M. Single-dose euglycaemic clamp studies demonstrating pharmacokinetic and pharmacodynamic similarity between MK-1293 insulin glargine and originator insulin glargine (Lantus) in subjects with type 1 diabetes and healthy subjects. Diabetes Obes Metab. 2018 Feb;20(2):400-408. doi: 10.1111/dom.13084. Epub 2017 Sep 26.

Reference Type: RESULT

PMID: 28817223 (View on PubMed)

Other Identifiers

2012-005656-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1293-005

Identifier Type: -

Identifier Source: org_study_id