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: September 26, 2014
Last verified: September 2014
  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
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: 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: September 26, 2014
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
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014