Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise. |
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Condition | Type 2 Diabetes |
Intervention | Drug: Saxagliptin Drug: Placebo Drug: Metformin |
Phase | Phase 3 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00661362 |
First Received | April 17, 2008 |
Last Updated | February 6, 2012 |
Last verified | February 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | April 17, 2008 |
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Last Updated Date | February 6, 2012 |
Start Date | June 2008 |
Estimated Primary Completion Date | September 2009 |
Current Primary Outcome Measures | Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) [Time Frame: Baseline , Week 24] [Designated as safety issue: No]Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes |
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Official Title | A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy |
Brief Summary | Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | Drug: Saxagliptin Oral tablet, once daily for 24 weeks Other Names: OnglyzaDrug: Placebo oral tablet, once daily for 24 weeks Drug: Metformin oral tablet, once daily for 24 weeks Other Names: Glucophage |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 570 |
Estimated Completion Date | September 2009 |
Estimated Primary Completion Date | September 2009 |
Eligibility Criteria | Inclusion Criteria: - Diagnosed with Type 2 diabetes - Treatment with metformin at a stable dose >1500 mg/day - HbA1c ≥ 7.0% and ≤10.0% Exclusion Criteria: - Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes) - Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China, India, Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00661362 |
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Other Study ID Numbers | D1680C00006 |
Has Data Monitoring Committee | Yes |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Bristol-Myers Squibb |
Investigators | Study Director: Peter Ohman, MD AstraZenecaStudy Chair: Deborah Price, MSc AstraZeneca |
Verification Date | February 2012 |
Locations[ + expand ][ + ]
Research Site | Hefei, Anhui, China |
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Research Site | Guangzhou, Guangdong, China |
Research Site | Shi Jiazhuang, Hebei, China |
Research Site | Ha'er Bing, Hei Longjiang, China |
Research Site | Wuhan, Hu Bei, 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, China |
Research Site | Chengdu, Sichuan, China |
Research Site | Hangzhou, Zhejiang, China |
Research Site | Beijing, China |
Research Site | Chongqing, 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, Gyeonggi-do, Korea, Republic of |
Research Site | Bucheon, Korea, Republic of |
Research Site | Daegu, Korea, Republic of |
Research Site | Goyang, Korea, Republic of |
Research Site | Gwangju, Korea, Republic of |
Research Site | Incheon, Korea, Republic of |
Research Site | Pusan, Korea, Republic of |
Research Site | Seoul, Korea, Republic of |
Research Site | Uijeongbu-si, Korea, Republic of |