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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Metformin + Saxagliptin |
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| 2 | Placebo Comparator | Metformin + Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | Oral tablet, once daily for 24 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) | 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. | Baseline , Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG 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 FPG. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Ohman, MD | AstraZeneca | Study Director |
| Deborah Price, MSc | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hefei | Anhui | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27402391 | Derived | 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. | |
| 21871686 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saxagliptin 5 mg + Metformin | Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks |
| FG001 | Placebo + Metformin | Placebo tablet, OD, added on to stable Metformin for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | oral tablet, once daily for 24 weeks |
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| Metformin | Drug | oral tablet, once daily for 24 weeks |
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| Baseline , Week 24 |
| Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG 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 FPG. | Baseline , Week 24 |
| Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup | Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC. | Baseline , Week 24 |
| Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup | Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC. | Baseline , Week 24 |
| Proportion of Patients Achieving a Therapeutic Glycemic Response | Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24 | Baseline , Week 24 |
| 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Saxagliptin 5 mg + Metformin | Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks |
| BG001 | Placebo + Metformin | Placebo tablet, OD, added on to stable Metformin for 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) | 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. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement. | Posted | Mean | Standard Error | percent | Baseline , Week 24 |
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| Secondary | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG 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 FPG. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement | Posted | Mean | Standard Error | mmol/L | Baseline , Week 24 |
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| Secondary | Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG 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 FPG. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement | Posted | Mean | Standard Error | mg/dL | Baseline , Week 24 |
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| Secondary | Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup | Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC. | MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data. | Posted | Mean | Standard Error | mmol*min/L | Baseline , Week 24 |
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| Secondary | Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup | Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC. | MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized participants who took at least 1 dose of double-blind treatment to be included in analysis: change from baseline to Wk 24 (LOCF), must have had a baseline and a post baseline data. | Posted | Mean | Standard Error | mg*min/dL | Baseline , Week 24 |
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| Secondary | Proportion of Patients Achieving a Therapeutic Glycemic Response | Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24 | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24(LOCF) for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement. | Posted | Number | Percentage of participants | Baseline , Week 24 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saxagliptin 5 mg + Metformin | Saxagliptin 5 mg tablet, once daily (OD), added on to stable Metformin for 24 weeks | 8 | 283 | 19 | 283 | ||
| EG001 | Placebo + Metformin | Placebo tablet, OD, added on to stable Metformin for 24 weeks | 3 | 287 | 13 | 287 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal Abscess | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Hepatitis B | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pulmonary Tuberculosis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Rib Fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| Cerebral Infarction | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Diabetic Foot | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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The Principal Investigator will provide AstraZeneca as soon as possible with preliminary data and drafts of proposed publications and disclosures, whether oral or in writing, with the proposed final manuscript. AZ shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Male |
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| adjusted baseline HbA1c |
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