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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00873821
First received: March 31, 2009
Last updated: June 6, 2012
Last verified: June 2012
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 23, 2014