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

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ClinicalTrials.gov Identifier: NCT00479466
Recruitment Status : 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)
First Posted : May 28, 2007
Results First Posted : November 11, 2011
Last Update Posted : September 9, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: MK0893 Drug: Metformin Drug: Placebo to MK0893 Drug: Placebo to Metformin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) [ Time Frame: Week 12 ]
  2. Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG) [ Time Frame: Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479466


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00479466     History of Changes
Other Study ID Numbers: 0893-008
2007_526
First Posted: May 28, 2007    Key Record Dates
Results First Posted: November 11, 2011
Last Update Posted: September 9, 2015
Last Verified: September 2015

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