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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 with inadequate glycaemic control with diet and exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin 5mg | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | 5mg, 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 versus placebo 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. HbA1c data were excluded on and after rescue medication. | Baseline , Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (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. FPG data were excluded on and after rescue medication. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Öhman, MD, PhD | AstraZeneca, Wilmington, USA | Study Director |
| Deborah Price, MSc | AstraZeneca, Wilmington, USA | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saxagliptin 5 mg | Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks |
| FG001 | Placebo | Placebo tablet, once daily( OD) 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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| Baseline, Week 24 |
| Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo 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. FPG data were excluded on and after rescue medication. | Baseline, Week 24 |
| Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants | Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication | Baseline , Week 24 |
| Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants | Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication | Baseline , Week 24 |
| Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24 | Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication | Baseline, Week 24 |
| Beijing |
| China |
| China |
| Research Site | Chongqing | China | China |
| Research Site | Fuzhou | Fujian | China |
| Research Site | Guangzhou | Guangdong | China |
| Research Site | Shijiazhuang | Hebei | 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 | Hyderabaad | Andhra Pradesh | India |
| Research Site | Bangalore | Karnataka | India |
| Research Site | Mangalore | Karnataka | India |
| Research Site | Mumbai | Maharashtra | India |
| Research Site | Nagpur | Maharashtra | India |
| Research Site | Pune | Maharashtra | India |
| Research Site | Coimbatore | India |
| Research Site | Cebu City | Philippines |
| Research Site | Makati City | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Marikina City | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Jeonju | Jeollabuk-do | South Korea |
| Research Site | Daegu | South Korea |
| Research Site | Seoul | South Korea |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Saxagliptin 5 mg | Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks |
| BG001 | Placebo | Placebo tablet, once daily( OD) 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 versus placebo 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. HbA1c data were excluded on and after rescue medication. | 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. If participant received rescue medication, that measurement must have been taken before rescue. | Posted | Mean | Standard Error | percent | Baseline , Week 24 |
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| Secondary | Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (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. FPG data were excluded on and after rescue medication. | 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. If participant received rescue medication, that measurement must have been taken before rescue. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 24 |
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| Secondary | Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo 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. FPG data were excluded on and after rescue medication. | 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. If participant received rescue medication, that measurement must have been taken before rescue. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 24 |
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| Secondary | Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants | Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication | MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, 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 baseline and post-baseline data. Measurements observed on and after rescue medication were excluded. | Posted | Mean | Standard Error | mmol*min/L | Baseline , Week 24 |
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| Secondary | Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants | Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication | MMTT was measured on a subset of patients in China cohort only at baseline and Wk 24. Randomized subjects, 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 baseline and post-baseline data. Measurements observed on and after rescue medication were excluded. | Posted | Mean | Standard Error | mg*min/dL | Baseline , Week 24 |
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| Secondary | Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24 | Proportion of participants (expressed in percentage of total participants) achieving HbA1c < 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication | 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. If participant received rescue medication, that measurement must have been taken before rescue. | 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 | Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks | 8 | 284 | 18 | 284 | ||
| EG001 | Placebo | Placebo tablet, once daily( OD) for 24 weeks | 4 | 284 | 22 | 284 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Unstable | Cardiac disorders | MedDRA 12 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 12 | Systematic Assessment |
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| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Anal Injury | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| Renal Abscess | Infections and infestations | MedDRA 12 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
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The Principal Investigator undertakes to provide AstraZeneca as soon as possible with preliminary data and drafts of proposed publications and disclosures, whether oral or in writing, and as soon as available, with the proposed final manuscript. AstraZeneca 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 |
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| C502994 | saxagliptin |
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