Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control
NCT ID: NCT00918879
Last Updated: 2011-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2009-05-31
2010-07-31
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
Saxagliptin
Saxagliptin
Oral tablet, once daily for 24 weeks
2
Placebo
Oral tablet, once daily for 24 weeks
Interventions
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Saxagliptin
Oral tablet, once daily for 24 weeks
Placebo
Oral tablet, once daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients should be drug naïve ie, not received medical treatment for diabetes
* HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)
Exclusion Criteria
* Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Peter Ohman, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca, Wilmington, USA
Deborah Price, MSc
Role: STUDY_CHAIR
AstraZeneca, Wilmington, USA
Locations
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Research Site
Gujarat, Ahmedabad, India
Research Site
Karnataka, Bangalore, India
Research Site
Tamil Nadu, Chennai, India
Research Site
Tamil Nadu, Coimbatore, India
Research Site
Andhra Pradesh, Hyderabad, India
Research Site
Madhya Pradesh, Indore, India
Research Site
Haryāna, Karnal, India
Research Site
Kerala, Kochi, India
Research Site
Maharashtra, Pune, India
Countries
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References
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Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
Other Identifiers
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D1680C00008
Identifier Type: -
Identifier Source: org_study_id