Trial | NCT00836940  Report issue

Title

A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    grc 8200 ...

  • Study Participants

    480
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.
Study Started
Jun 30
2008
Primary Completion
May 31
2009
Study Completion
Oct 31
2009
Anticipated
Last Update
Sep 24
2009
Estimate

Drug GRC 8200

Capsules, 25 to 100mg, once/ twice a day, 12 weeks

1 Placebo Comparator

2 Experimental

GRC 8200-25mg OD

3 Experimental

GRC 8200-50mg OD

4 Experimental

GRC 8200-50mg BD

5 Experimental

GRC 8200-100mg OD

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
No Results Posted