A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus

• Status: Unknown status
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.

The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.

This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glenmark Pharmaceuticals Europe Ltd. (R&D)

Criteria

Inclusion Criteria:

• Male or female patients ≥30 years of age

• At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception

• Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period

• Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs

• Has an HbA1c value at screening between 6.5% and 10%

Exclusion Criteria:

• Has type 1 diabetes

• Is a female who is lactating or is pregnant

• Has a history of acute metabolic diabetic complications

• Has clinically significant disease other than type 2 diabetes mellitus