Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone
- Registration Number
- NCT01257412
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 375
Inclusion Criteria
- Provision of informed consent before participating in the study
- Diagnosed with type 2 diabetes (high blood sugar); HbA1c ≥ 7.2% and ≤10.0%
- Subjects should be drug naïve
- Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative serum or urine pregnancy test
Exclusion Criteria
- Subjects received Insulin therapy within one year of enrollment
- Subjects who have severe uncontrolled hypertension
- Subjects who have history of unstable or rapidly progressing renal disease
- Subjects who have severe liver disease
- Subjects who receiving treatment for Human immunodeficiency virus (HIV)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 placebo - 1 Dapagliflozin - 2 Dapagliflozin -
- Primary Outcome Measures
Name Time Method change in glycosylated haemoglobin A1c (HbA1c). From baseline to week 24
- Secondary Outcome Measures
Name Time Method mean change in fasting plasma glucose (FPG) From baseline to week 24 mean change in 2- hour postprandial glucose by Mixed Meal Test From baseline to week 24 mean change from baseline in fasting plasma glucose (FPG) From baseline to week 1
Trial Locations
- Locations (1)
Research Site
🇮🇳Ghaziabad, Uttar Pradesh, India