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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 Indian patients with inadequate glycaemic control with diet and exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Saxagliptin |
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| 2 | Placebo Comparator |
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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 glycosylated haemoglobin A1c (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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Ohman, MD, PhD | AstraZeneca, Wilmington, USA | Study Director |
| Deborah Price, MSc | AstraZeneca, Wilmington, USA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gujarat | Ahmedabad | India | |||
| 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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| 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 glycosylated haemoglobin A1c (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 of 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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| 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 13 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C502994 | saxagliptin |
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| Placebo | Drug | Oral tablet, once daily for 24 weeks |
|
| Baseline , Week 24 |
| Proportion of Patients (Expressed in Percentage of Total Participants) 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 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication | Baseline , Week 24 |
| 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 |
| Severe non-compliance to protocol |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo tablet, once daily( OD) for 24 weeks |
|
|
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| Secondary | Absolute Change 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 of 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 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 of 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 | Proportion of Patients (Expressed in Percentage of Total Participants) 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 (LOCF, Full Analysis set). 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 of 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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| 0 |
| 107 |
| 9 |
| 107 |
| EG001 | Placebo | Placebo tablet, once daily( OD) for 24 weeks | 0 | 106 | 10 | 106 |
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| D004700 | Endocrine System Diseases |
| Adjusted Change from Baseline to Week 24 |
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| Adjusted Change from Baseline to Week 24 |
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