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| ID | Type | Description | Link |
|---|---|---|---|
| CV181-117 |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.
A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin 5 mg once daily | Experimental |
| |
| Placebo once daily | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | 5 mg tablet once daily for 24 weeks to be taken orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF) | Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model | From Baseline to Week 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] | Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model | From Baseline to Week 24 |
| Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayanti Visvanthan, MD | AstraZeneca | Study Chair |
| Simon Fisher, MD | AstraZeneca | Study Chair |
| Vinod Mattoo, MD | Bristol-Myers Squibb | Study Chair |
| Robert Moses, MBBS | Sydney Diabetes Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Broadmeadow | New South Wales | Australia | |||
| Research Site |
Participants were screened over 2 week period. 383 participants enrolled; 126 excluded (11 declined, 114 did not meet eligibility criteria, 1 lost to follow up).
Participants were recruited to the study from 35 centres in 6 countries (Australia, United Kingdom, Canada, Korea, India and Thailand). Participants were recruited between June 2010 and December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | SAXAGLIPTIN | Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally |
| FG001 | PLACEBO | Placebo tablet once daily for 24 weeks to be taken orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | tablet once daily for 24 weeks to be taken orally |
|
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model |
| From Baseline to Week 24 |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] | Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance | From Baseline to Week 24 |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] | Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model | From Baseline to Week 24 |
| Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF) | Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24 | From Baseline to Week 24 |
| Wollongong |
| New South Wales |
| Australia |
| Research Site | Daw Park | South Australia | Australia |
| Research Site | Elizabeth Vale | South Australia | Australia |
| Research Site | Melbourne | Victoria | Australia |
| Research Site | Camperdown | Australia |
| Research Site | Herston | Australia |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Sydney Mines | Nova Scotia | Canada |
| Research Site | Thornhill | Ontario | Canada |
| Research Site | Kensington | Prince Edward Island | Canada |
| Research Site | Karnāl | Haryana | India |
| Research Site | Bangalore | Karnataka | India |
| Research Site | Indore | Madhya Pradesh | India |
| Research Site | Pune | Maharashtra | India |
| Research Site | Coimbatore | Tamil Nadu | India |
| Research Site | Wŏnju | Gangwon-do | South Korea |
| Research Site | Goyang | Kyounggi-do | South Korea |
| Research Site | Daegu | South Korea |
| Research Site | Seoul | South Korea |
| Research Site | Bangkok | Thailand |
| Research Site | Reading | Berks | United Kingdom |
| Research Site | Ely | Cambridgeshire | United Kingdom |
| Research Site | Whitstable | Kent | United Kingdom |
| Research Site | Westbury | Wiltshire | United Kingdom |
| Research Site | Ashford | United Kingdom |
| Research Site | Belfast | United Kingdom |
| Research Site | Blackpool | United Kingdom |
| Research Site | Chesterfield | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Glasgow | United Kingdom |
| Research Site | Peterborough | United Kingdom |
| Research Site | Wellingborough | United Kingdom |
| Full Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SAXAGLIPTIN | Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally |
| BG001 | PLACEBO | Placebo tablet once daily for 24 weeks to be taken orally |
| 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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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | Participants |
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| BMI | Mean | Standard Deviation | kg/m2 |
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| HbA1c | Mean | Standard Deviation | % |
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| 2-hour Postprandial Glucose | Mean | Standard Deviation | mg/dL |
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| 2-hour Postprandial glucose | Mean | Standard Deviation | mmol/L |
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| Fasting Plasma Glucose | Mean | Standard Deviation | mg/dL |
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| Fasting Plasma Glucose | Mean | Standard Deviation | mmol/L |
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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 | Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF) | Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model | Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle. | Posted | Jun 2012 | Mean | 95% Confidence Interval | percent | From Baseline to Week 24 weeks |
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| Secondary | Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] | Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model | Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle. | Posted | Jun 2012 | Mean | 95% Confidence Interval | mg/dL | From Baseline to Week 24 |
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| Secondary | Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] | Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model | Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle. | Posted | Jun 2012 | Mean | 95% Confidence Interval | mmol/L | From Baseline to Week 24 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL] | Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance | Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle. | Posted | Jun 2012 | Mean | 95% Confidence Interval | mg/dL | From Baseline to Week 24 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L] | Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model | Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle. | Posted | Jun 2012 | Mean | 95% Confidence Interval | mmol/L | From Baseline to Week 24 |
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| Secondary | Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF) | Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24 | Full Analysis Set which included all participants randomised to the study who received at least 1 dose of investigational product and who had a non-missing baseline value and at least 1 post-baseline measure. The full analysis set follows intention-to-treat principle. | Posted | Jun 2012 | Number | Participants | From Baseline to 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 | Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally | 3 | 129 | 53 | 129 | ||
| EG001 | PLACEBO | Placebo tablet once daily for 24 weeks to be taken orally | 7 | 128 | 65 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Laryngeal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
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| Cartilage Injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Renal Colic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Oral Candidiasis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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At least 60 days prior to submission of any material for publication or presentation, PI shall provide Sponsor with such material for review. If requested in writing by Sponsor, PI shall withhold material from submission for publication or presentation for an additional 90 days from the date of Sponsor's request.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1625 518062 | 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 |
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| Male |
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| Asian |
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| Canada |
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| India |
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| Korea, Republic of |
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| Thailand |
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| United Kingdom |
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