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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2007-004951-12 |
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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 test the efficacy of once daily saxagliptin in renally impaired patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxa | Experimental | Saxagliptin |
|
| Placebo | No Intervention | Placebo to match |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | 2.5 mg once daily oral dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) | Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Baseline , Week 12 (LOCF) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Ohman, MD, PhD | AstraZeneca | Study Director |
| Deborah Price, MSc | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Concord | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21332627 | Derived | Nowicki M, Rychlik I, Haller H, Warren ML, Suchower L, Gause-Nilsson I; D1680C00007 Investigators. Saxagliptin improves glycaemic control and is well tolerated in patients with type 2 diabetes mellitus and renal impairment. Diabetes Obes Metab. 2011 Jun;13(6):523-32. doi: 10.1111/j.1463-1326.2011.01382.x. |
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A total of 572 participants were enrolled in the study; 561 entered the Lead-in period and 170 patients were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Saxa | Saxagliptin 2.5 mg once daily oral dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo |
|
| Baseline, Week 12 (LOCF) |
| Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Baseline, Week 12 (LOCF) |
| Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Baseline, Week 12 (LOCF) |
| Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Baseline, Week 12 (LOCF) |
| Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52 | Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Baseline , Week 52 |
| Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Baseline, Week 52 |
| Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Baseline, Week 52 |
| Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Baseline, Week 52 |
| Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value | Baseline, Week 52 |
| Sacramento |
| California |
| United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Topeka | Kansas | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Great Falls | Montana | United States |
| Research Site | Greenville | North Carolina | United States |
| Research Site | Morehead City | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Corpus Christi | Texas | United States |
| Research Site | Charleston | West Virginia | United States |
| Research Site | Brest | Belarus |
| Research Site | Homyel | Belarus |
| Research Site | Minsk | Belarus |
| Research Site | Dimitrovgrad | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Veliko Tarnovo | Bulgaria |
| Research Site | Rijeka | Croatia | Croatia |
| Research Site | Karlovac | Croatia |
| Research Site | Osijek | Croatia |
| Research Site | Split | Croatia |
| Research Site | Zagreb | Croatia |
| Research Site | Moravský Krumlov | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Teplice | Czechia |
| Research Site | Ústí nad Labem | Czechia |
| Research Site | Znojmo | Czechia |
| Research Site | Tallinn | Estonia |
| Research Site | Dieburg | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Hanover | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Mannheim | Germany |
| Research Site | Debrecen | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Kalocsa | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Zalaegerszeg | Hungary |
| Research Site | Riga | Latvia |
| Research Site | Kaunas | Lithuania |
| Research Site | Klaipėda | Lithuania |
| Research Site | Panevezys | Lithuania |
| Research Site | Vilnius | Lithuania |
| Research Site | Lodz | 90-153 | Poland |
| Research Site | Bialystok | Poland |
| Research Site | Ciechanów | Poland |
| Research Site | Golub-Dobrzyń | Poland |
| Research Site | Grodzisk Mazowiecki | Poland |
| Research Site | Katowice | Poland |
| Research Site | Krakow | Poland |
| Research Site | Maków Mazowiecki | Poland |
| Research Site | Radom | Poland |
| Research Site | Szczecin | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Zabrze | Poland |
| Research Site | Bacau | Bacău | Romania |
| Research Site | Brasov | Brașov County | Romania |
| Research Site | Satu Mare | Satu Mare County | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Sf Gheorghe | Romania |
| Research Site | Chelyabinsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Ryazan | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Dnipropetrovsk | Ukraine |
| Research Site | Ivano-Frankivsk | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Kyiv | Ukraine |
| Research Site | Mykolayiv | Ukraine |
| Research Site | Sumy | Ukraine |
| Research Site | Ternopil | Ukraine |
| Research Site | Zaporizhzhya | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Saxa | Saxagliptin 2.5 mg once daily oral dose |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Renal Impairment Category | Number | Participants |
| ||||||||||||||||
| Baseline Diabetes Therapy | Number | 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 in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) | Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. | Posted | Mean | Standard Error | Percent | Baseline , Week 12 (LOCF) |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (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 12 (LOCF) |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (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 12 (LOCF) |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (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 12 (LOCF) |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (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 12 (LOCF) |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (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 12 (LOCF) |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (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 12 (LOCF) |
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| Secondary | Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52 | Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin. | Posted | Mean | Standard Error | Percent | Baseline , Week 52 |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 52 |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 52 |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 52 |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 52 |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 52 |
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| Secondary | Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup | Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 52 |
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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 | Placebo | Placebo | 24 | 85 | 36 | 85 | ||
| EG001 | Saxa | Saxagliptin 2.5 mg once daily oral dose | 23 | 85 | 38 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Poor Peripheral Circulation | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Malignant Fibrous Histiocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Infected Skin Ulcer | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Bifascicular Block | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cauda Equina Syndrome | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cerebral Hypoperfusion | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Arteriovenous Fistula | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Femoral Artery Occlusion | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Peripheral Ischaemia | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Iridocyclitis | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pseudoexfoliation Of Lens Capsule | Eye disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oedema | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Calculus Ureteric | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Skin Disorder | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Arteriovenous Fistula Thrombosis | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Arteriovenous Fistula Operation | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Oedema Peripheral | General disorders | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502994 | saxagliptin |
Not provided
Not provided
Not provided
| Male |
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| Severe |
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| End-Stage |
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| Insulin |
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| Oral blood glucose lowering drug |
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