Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2007-006095-11 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sitagliptin in addition with metformin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | saxagliptin add-on to metformin |
|
| 2 | Active Comparator | sitagliptin add-on to metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saxagliptin | Drug | tablet, per oral, once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Baseline, Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 | Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set) | Week 18 (Last Observation Carried Forward) |
| Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| André Scheen, Professor | Clinical Pharmacology Unit, Liege, Belgium | Principal Investigator |
| 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 | Buenos Aires | Buenos Aires | Argentina | |||
| Research Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Saxa + Met | Saxagliptin 5 mg tablets added on to open-label metformin |
| FG001 | Sita + Met | Sitagliptin 100 mg capsules added on to open-label metformin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sitagliptin | Drug | capsule, per oral, once daily |
|
|
Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value. |
| Baseline, Week 18 (Last Observation Carried Forward) |
| Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) | Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value. | Baseline, Week 18 (Last Observation Carried Forward) |
| Lanus |
| Buenos Aires |
| Argentina |
| Research Site | Mar del Plata | Buenos Aires | Argentina |
| Research Site | Santa Fe | Santa Fe Province | Argentina |
| Research Site | Caba | Argentina |
| Research Site | Capital Federal | Argentina |
| Research Site | Ciudad de Buenos Aires | Argentina |
| Research Site | Córdoba | Argentina |
| Research Site | Rosario | Argentina |
| Research Site | Aalst | Belgium | Belgium |
| Research Site | Bonheiden | Belgium | Belgium |
| Research Site | Genk | Belgium | Belgium |
| Research Site | Gozée | Belgium | Belgium |
| Research Site | Hasselt | Belgium | Belgium |
| Research Site | Liège | Belgium | Belgium |
| Research Site | Saint-Médard | Belgium | Belgium |
| Research Site | Sint-Gillis-Waas | Belgium | Belgium |
| Research Site | Tessenderlo | Belgium | Belgium |
| Research Site | Thuillies | Belgium | Belgium |
| Research Site | Bruges | Belgium |
| Research Site | Aalborg | Denmark |
| Research Site | Aarhus | Denmark |
| Research Site | Christiansfeld | Denmark |
| Research Site | Farsø | Denmark |
| Research Site | Gentofte Municipality | Denmark |
| Research Site | Hobro | Denmark |
| Research Site | Kolding | Denmark |
| Research Site | Rødovre Municipality | Denmark |
| Research Site | Viborg | Denmark |
| Research Site | Angers | France |
| Research Site | Château-Gontier | France |
| Research Site | Corbeil-Essonnes | France |
| Research Site | La Seyne-sur-Mer | France |
| Research Site | Laval | France |
| Research Site | Le Lavandou | France |
| Research Site | Montrevault | France |
| Research Site | Saint-Cyr | France |
| Research Site | Tiercé | France |
| Research Site | Toulon | France |
| Research Site | Witry-lès-Reims | France |
| Research Site | Bergamo | BG | Italy |
| Research Site | Foggia | FG | Italy |
| Research Site | Chiavari | GE | Italy |
| Research Site | Genova | GE | Italy |
| Research Site | Rozzano | MI | Italy |
| Research Site | Olbia | OT | Italy |
| Research Site | Padova | PD | Italy |
| Research Site | Pordenone | PN | Italy |
| Research Site | Mercato San Severino | SA | Italy |
| Research Site | Siena | SI | Italy |
| Research Site | México | D.f. | Mexico |
| Research Site | Guadalajara | Jalisco | Mexico |
| Research Site | Monterrey | Mexico |
| Research Site | Ålesund | Norway |
| Research Site | Elverum | Norway |
| Research Site | Halden | Norway |
| Research Site | Hamar | Norway |
| Research Site | Lierskogen | Norway |
| Research Site | Lillehammer | Norway |
| Research Site | Oslo | Norway |
| Research Site | Sandvika | Norway |
| Research Site | Strømmen | Norway |
| Research Site | Svelvik | Norway |
| Research Site | Benoni | Gauteng | South Africa |
| Research Site | Johannesburg | Gauteng | South Africa |
| Research Site | Cape Town | South Africa | South Africa |
| Research Site | Durban | South Africa | South Africa |
| Research Site | Cape Town | Western Cape | South Africa |
| Research Site | Bloemfontein | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Kwa Zulu Natal | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Borås | Sweden |
| Research Site | Degeberga | Sweden |
| Research Site | Finspång | Sweden |
| Research Site | Gothenburg | Sweden |
| Research Site | Jönköping | Sweden |
| Research Site | Ödeshög | Sweden |
| Research Site | Örebro | Sweden |
| Research Site | Piteå | Sweden |
| Research Site | Rättvik | Sweden |
| Research Site | Skanör | Sweden |
| Research Site | Timrå | Sweden |
| Research Site | Trollhättan | Sweden |
| Research Site | Uddevalla | Sweden |
| Research Site | Umeå | Sweden |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Saxa + Met | Saxagliptin 5 mg tablets added on to open-label metformin |
| BG001 | Sita + Met | Sitagliptin 100 mg capsules added on to open-label metformin |
| 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 |
|
| 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 | Hemoglobin A1c (HbA1c) Change From Baseline to Week 18 | Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 18 value minus the baseline value. | Randomized participants who completed the 18 weeks of treatment had both baseline and week 18 HbA1c measurement and had no significant protocol deviations. | Posted | Mean | Standard Error | Percent | Baseline, Week 18 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 | Proportion of Patients Achieving Therapeutic Glycaemic Response Defined as HbA1c <= 6.5% at Week 18 (Full Analysis Set) | Randomized participants who took at least 1 dose of double-blind treatment. To be included in the Week 18 LOCF analysis, participants must have had a baseline and at least 1 post-baseline measurement. | Posted | Number | Percentage of Participants | Week 18 (Last Observation Carried Forward) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Glucose Change From Baseline to Week 18 (mg/dL) | Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 18 (Last Observation Carried Forward) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Fasting Plasma Glucose Change From Baseline to Week 18 (mmol/L) | Adjusted mean change from baseline in Fasting Plasma Glucose achieved with saxagliptin added on to metformin versus sitagliptin added on to metformin at Week 18 (Full Analysis Set). Fasting Plasma Glucose is a continuous measure, the change from baseline for each participant is calculated as the Week 18 (LOCF) value minus the baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis of change from baseline to Week 18 LOCF, participants must have had a baseline and at least 1 post-baseline measurement. | Posted | Mean | Standard Error | mmol/L | Baseline, Week 18 (Last Observation Carried Forward) |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saxa + Met | Saxagliptin 5 mg tablets added on to open-label metformin | 7 | 403 | 54 | 403 | ||
| EG001 | Sita + Met | Sitagliptin 100 mg capsules added on to open-label metformin | 5 | 398 | 50 | 398 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ulcer Haemorrhage | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypoglycaemic Unconsciousness | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Aortic Aneurysm | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C502994 | saxagliptin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
Not provided
Not provided
| Male |
|
| Adjusted Change from Baseline |
|
|
|
|
|
|
|