Dose-Range Finding Study for MK0893 (0893-008)

This study has been terminated.
(Sufficient data regarding the dose-response to MK-0893 had been obtained from the first cohort of the study to assess the safety and efficacy)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00479466
First received: May 25, 2007
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: MK0893
Drug: Metformin
Drug: Placebo to MK0893
Drug: Placebo to Metformin
Phase 2

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 Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 342
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK0893 80 mg
MK0893 tablets totaling 80 mg once daily.
Drug: MK0893
MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
Drug: Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
Drug: Placebo to Metformin
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
Experimental: MK0893 60 mg
MK0893 tablets totaling 60 mg once daily.
Drug: MK0893
MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
Drug: Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
Drug: Placebo to Metformin
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
Experimental: MK0893 40 mg
MK0893 40 mg tablet once daily.
Drug: MK0893
MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
Drug: Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
Drug: Placebo to Metformin
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
Experimental: MK0893 20 mg
MK0893 20 mg tablet once daily.
Drug: MK0893
MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
Drug: Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
Drug: Placebo to Metformin
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.
Active Comparator: Metformin
Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.
Drug: Metformin
Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
Drug: Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
Placebo Comparator: Placebo
PLA tablets. 12 week treatment period.
Drug: Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
Drug: Placebo to Metformin
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion Criteria:

  • Patients have a history of Type 1 Diabetes Mellitus
  • Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor [PPAR]-gamma agonist)
  • Patients who have a contraindication to metformin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479466

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: NCT00479466     History of Changes
Other Study ID Numbers: 0893-008, 2007_526
Study First Received: May 25, 2007
Results First Received: October 7, 2011
Last Updated: October 15, 2013
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
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014