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
NCT ID: NCT01257412
Last Updated: 2012-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
375 participants
INTERVENTIONAL
2012-01-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Dapagliflozin
5mg Oral dose od
2
Dapagliflozin
10 mg Oral dose od
3
placebo
5/10 mg Oral dose od
Interventions
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Dapagliflozin
5mg Oral dose od
Dapagliflozin
10 mg Oral dose od
placebo
5/10 mg Oral dose od
Eligibility Criteria
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Inclusion Criteria
* 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 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)
19 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. A. Ramachandran, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dr. A. Ramachandran's Diabetes Hospital
Locations
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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
Countries
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Other Identifiers
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D1693C00002
Identifier Type: -
Identifier Source: org_study_id
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