Status:
UNKNOWN
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
Lead Sponsor:
Glenmark Pharmaceuticals Europe Ltd. (R&D)
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 current...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00836940
Start Date
June 1 2008
End Date
October 1 2009
Last Update
September 24 2009
Active Locations (1)
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1
Glenmark Investigational site
Mumbai, India