Status:
SUSPENDED
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
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 alon...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT01257412
Start Date
January 1 2012
End Date
June 1 2013
Last Update
March 1 2012
Active Locations (15)
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1
Research Site
Hyderabad, Andhra Pradesh, India
2
Research Site
Vijaywada, Andhra Pradesh, India
3
Research Site
Ahmedabad, Gujarat, India
4
Research Site
Bangalore, Karnataka, India