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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: Placebo to Metformin; Drug: MK0893; Drug: Placebo to MK0893

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479466

2007_526

0893-008

Details and patient eligibility

About

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

Enrollment: 342 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

342 participants in 6 patient groups, including a placebo group

MK0893 80 mg

Experimental group

Description:

MK0893 tablets totaling 80 mg once daily.

Treatment:

Drug: Placebo to Metformin

Drug: MK0893

Drug: Placebo to MK0893

MK0893 60 mg

Experimental group

Description:

MK0893 tablets totaling 60 mg once daily.

Treatment:

Drug: Placebo to Metformin

Drug: MK0893

Drug: Placebo to MK0893

MK0893 40 mg

Experimental group

Description:

MK0893 40 mg tablet once daily.

Treatment:

Drug: Placebo to Metformin

Drug: MK0893

Drug: Placebo to MK0893

MK0893 20 mg

Experimental group

Description:

MK0893 20 mg tablet once daily.

Treatment:

Drug: Placebo to Metformin

Drug: MK0893

Drug: Placebo to MK0893

Metformin

Active Comparator group

Description:

Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks.

Treatment:

Drug: Metformin

Drug: Placebo to MK0893

Placebo

Placebo Comparator group

Description:

PLA tablets. 12 week treatment period.

Treatment:

Drug: Placebo to Metformin

Drug: Placebo to MK0893