| Trial ID: | L2884 |
| Source ID: | NCT00836940
|
| Associated Drug: |
Grc 8200
|
| Title: |
A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: GRC 8200
|
| Outcome Measures: |
Primary: Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period, 12 weeks | Secondary: Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment, 4 and 8 weeks|Fasting plasma glucose and fasting serum insulin, 12 weeks|Plasma glucose 2 hours post glucose challenge (OGTT), 12 weeks|HOMA-IR, 12 weeks|HOMA-B, 12 weeks|Change in serum lipids, 12 weeks|Body weight, 12 weeks|Waist circumference, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Glenmark Pharmaceuticals Europe Ltd. (R&D)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
480
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-06
|
| Completion Date: |
2009-10
|
| Results First Posted: |
|
| Last Update Posted: |
2009-09-24
|
| Locations: |
Glenmark Investigational site, Mumbai, India
|
| URL: |
https://clinicaltrials.gov/show/NCT00836940
|
