Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
NCT ID: NCT00661362
Last Updated: 2012-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
570 participants
INTERVENTIONAL
2008-06-30
2009-09-30
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
Metformin + Saxagliptin
Saxagliptin
Oral tablet, once daily for 24 weeks
Metformin
oral tablet, once daily for 24 weeks
2
Metformin + Placebo
Placebo
oral tablet, once daily for 24 weeks
Metformin
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
Metformin
oral tablet, once daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with metformin at a stable dose \>1500 mg/day
* HbA1c ≥ 7.0% and ≤10.0%
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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Principal Investigators
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Peter Ohman, MD
Role: STUDY_DIRECTOR
AstraZeneca
Deborah Price, MSc
Role: STUDY_CHAIR
AstraZeneca
Locations
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Research Site
Hefei, Anhui, China
Research Site
Beijing, China, China
Research Site
Chongqing, China, China
Research Site
Guangzhou, Guangdong, China
Research Site
Shijiazhuang, Hebei, China
Research Site
Ha'er Bing, Hei Longjiang, China
Research Site
Wuhan, Hubei, China
Research Site
Changsha, Hunan, China
Research Site
Nanjing, Jiangsu, China
Research Site
Changchun, Jilin, China
Research Site
Dalian, Liaoning, China
Research Site
Shenyang, Liaoning, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Chengdu, Sichuan, China
Research Site
Hangzhou, Zhejiang, China
Research Site
Tianjin, , China
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Bangalore, Karnataka, India
Research Site
Mangalore, Karnataka, India
Research Site
Nagpur, Maharashtra, India
Research Site
Bangalore, , India
Research Site
Seongnam-si, Gyeonggi-do, South Korea
Research Site
Bucheon-si, , South Korea
Research Site
Daegu, , South Korea
Research Site
Goyang, , South Korea
Research Site
Gwangju, , South Korea
Research Site
Incheon, , South Korea
Research Site
Pusan, , South Korea
Research Site
Seoul, , South Korea
Research Site
Uijeongbu-si, , South Korea
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.
Yang W, Pan CY, Tou C, Zhao J, Gause-Nilsson I. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Res Clin Pract. 2011 Nov;94(2):217-24. doi: 10.1016/j.diabres.2011.07.035. Epub 2011 Aug 26.
Other Identifiers
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D1680C00006
Identifier Type: -
Identifier Source: org_study_id
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