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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00479466
• Other study ID #: 0893-008
• Secondary ID: 2007_526
• Status: Terminated
• Phase: Phase 2
• First received: May 25, 2007
• Last updated: September 8, 2015
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 342
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• MK0893
MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose.
• Metformin
Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks.
• Placebo to MK0893
Dose-matched placebo tablets to MK0893; taken orally once daily.
• Placebo to Metformin
Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)		Week 12	No
Secondary	Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)		Week 12	No
Secondary	Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)		Week 12	No