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
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Dapagliflozin (Drug); Dapagliflozin (Drug); placebo (Drug)
Phase: Phase 3
Status: Suspended
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Prof. A. Ramachandran, MD, PhD, Principal Investigator, Affiliation: Dr. A. Ramachandran's Diabetes Hospital
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.
Clinical Details
Official title: A 24-week National Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Trial in India to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: change in glycosylated haemoglobin A1c (HbA1c).
Secondary outcome: mean change in fasting plasma glucose (FPG)mean change in 2- hour postprandial glucose by Mixed Meal Test mean change from baseline in fasting plasma glucose (FPG)
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Research Site, Hyderabad, Andhra Pradesh, India
Research Site, Vijaywada, Andhra Pradesh, India
Research Site, Ahmedabad, Gujarat, India
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
Research Site, Jaipur, Rajasthan, India
Research Site, Chennai, Tamil Nadu, India
Research Site, Coimbatore, Tamil Nadu, India
Research Site, Madurai, Tamil Nadu, India
Research Site, Ghaziabad, Uttar Pradesh, India
Additional Information
Starting date: January 2012
Last updated: February 29, 2012
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