This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
375
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Vijaywada, Andhra Pradesh, India
Research Site
Ahmedabad, Gujarat, India
change in glycosylated haemoglobin A1c (HbA1c).
Time frame: From baseline to week 24
mean change in fasting plasma glucose (FPG)
Time frame: From baseline to week 24
mean change in 2- hour postprandial glucose by Mixed Meal Test
Time frame: From baseline to week 24
mean change from baseline in fasting plasma glucose (FPG)
Time frame: From baseline to week 1
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Research Site
Bangalore, Karnataka, India
Research Site
Mysore, Karnataka, India
Research Site
Trivandrum, Kerala, India
Research Site
Indore, Madhya Pradesh, India
Research Site
Mumbai, Maharashtra, India
Research Site
Nagpur, Maharashtra, India
Research Site
Pune, Maharashtra, India
...and 5 more locations