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

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: MK-0941 Drug: Comparator: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of Participants With Any Clinical Adverse Experience [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24

Enrollment:	44
Study Start Date:	December 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MK-0941	Drug: MK-0941 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.
Placebo Comparator: 2 Placebo Comparator	Drug: Comparator: Placebo 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.

Arms

Assigned Interventions

Experimental: 1

MK-0941

Drug: MK-0941

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.

Placebo Comparator: 2

Placebo Comparator

Drug: Comparator: Placebo

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873821

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00873821 History of Changes
Other Study ID Numbers:	MK-0941-012, 2008_533
Study First Received:	March 31, 2009
Results First Received:	April 10, 2012
Last Updated:	June 6, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 23, 2013