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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Capsules, 25 to 100mg, once/ twice a day, 12 weeks
Glenmark Investigational site
Mumbai, India
Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
Time frame: 12 weeks
Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment
Time frame: 4 and 8 weeks
Fasting plasma glucose and fasting serum insulin
Time frame: 12 weeks
Plasma glucose 2 hours post glucose challenge (OGTT)
Time frame: 12 weeks
HOMA-IR
Time frame: 12 weeks
HOMA-B
Time frame: 12 weeks
Change in serum lipids
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
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