A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)

A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject has a BMI < 42 kg/m2
Subject is taking >1500 mg metformin per day for at least 8 weeks
Subject has HbA1c value of 7.0% and < 11% at screening
Subject is willing to follow AHA weight maintaining diet and exercise program
Subject is a nonsmoker for at least 6 months

Exclusion criteria

Subject has type 1 diabetes
Subject has a history of stroke or chronic seizure
Subject has a history of neoplastic disease
Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney, respiratory, immunological or genitourinary disorders or diseases
Subject is currently taking 2 or more diabetes medications
Subject has glaucoma or is blind
If female, subject is pregnant or breastfeeding
Subject consumes > 3 alcoholic beverages per day
Subject has had major surgery or has donated blood in the last 4 weeks

Treatment and study plan

MK-0941

Drug

Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.

Comparator: placebo

Drug

Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.

Primary outcomes

Number of Participants With Any Clinical Adverse Experience

Time frame: 2 months

An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.
Number of Participants With Any Laboratory Adverse Experience

Time frame: 2 months

Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.
Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration

Time frame: Baseline (predose Day 1) to Day 13

Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 2, 2009
Registry last updated: Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed