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

September 8, 2015 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
Drug: Metformin
Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)
Time Frame: Week 12
Week 12
Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 25, 2007

First Submitted That Met QC Criteria

May 25, 2007

First Posted (Estimate)

May 28, 2007

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0893-008
  • 2007_526

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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