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The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.
A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Experimental | Saxagliptin, oral 5mg once a day(Q. D.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | oral, 5 mg once a day (Q.D.) |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Haemoglobin A1c (HbA1c) | Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise. | Weeks 6, 12, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (%) of Patients Achieving HbA1c <7% | Weeks 6, 12, and 24 | |
| Change From Baseline in Fasting Plasma Glucose (FPG) | Weeks 6, 12, 18, and 24 | |
| Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon Fisher | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baotou | China | ||||
| Research Site |
A total of 2165 patients were screened and 741 patients were excluded due to violation of any inclusion and exclusion criteria.
This study was conducted at 92 study centers in China. First subject enrolled: 28 Nov 2012; Last subject last visit: 16 May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Saxagliptin | Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 24 |
| Beijing |
| China |
| Research Site | Benxi | China |
| Research Site | Changchun | China |
| Research Site | Chengdu | China |
| Research Site | Chongqing | China |
| Research Site | Dalian | China |
| Research Site | Dongguan | China |
| Research Site | Foshan | China |
| Research Site | Fuzhou | China |
| Research Site | Guangzhou | China |
| Research Site | Guiyang | China |
| Research Site | Haikou | China |
| Research Site | Hangzhou | China |
| Research Site | Hhht | China |
| Research Site | Hubei | China |
| Research Site | Jimo | China |
| Research Site | Jinan | China |
| Research Site | Kunming | China |
| Research Site | Linyi | China |
| Research Site | Nanjing | China |
| Research Site | Nantong | China |
| Research Site | Qingdao | China |
| Research Site | Shanghai | China |
| Research Site | Shantou | China |
| Research Site | Shenyang | China |
| Research Site | Shiyan | China |
| Research Site | Suzhou | China |
| Research Site | Taiyuan | China |
| Research Site | Tianjin | China |
| Research Site | Ürümqi | China |
| Research Site | Wenzhou | China |
| Research Site | Wuhan | China |
| Research Site | Wuxi | China |
| Research Site | Xi'an | China |
| Research Site | Zhanjiang | China |
| Research Site | Zhengzhou | China |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Saxagliptin | Saxagliptin oral 5mg once a day(Q. D.) 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 | Standard Deviation | years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Baseline haemoglobin A1c (HbA1c) | Mean | Standard Deviation | % |
| ||||||||||||||||||||||
| Baseline fasting plasma glucose (FPG) | 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 | Absolute Change From Baseline in Haemoglobin A1c (HbA1c) | Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise. | Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations. | Posted | Mean | Standard Error | (%) | Weeks 6, 12, and 24 |
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| Secondary | Proportion (%) of Patients Achieving HbA1c <7% | Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations. | Posted | Number | Percentage | Weeks 6, 12, and 24 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations. | Posted | Mean | Standard Error | mmol/L | Weeks 6, 12, 18, and 24 |
|
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| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG) | Patients who participated in standard noodle test in the per-protocoal analysis set (PPS), which included patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations. | Posted | Mean | Standard Error | mmol/L | Week 24 |
|
|
24 weeks
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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 oral 5mg once a day(Q. D.) for 24 weeks | 24 | 1,361 | 69 | 1,361 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Diabetic foot infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Hepatitis B | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Tuberculosis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
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| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
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| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Ligament injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
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| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA 13.1 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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This was a single-arm study and thus potential placebo effect was unable to be adjusted in any efficacy analyses.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anya Huang, Brand Physician | Astrazeneca Investment (China) Co., Ltd. | +86 21 6030 2032 | anya.huang@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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| Title | Measurements |
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| Week 6 |
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| Week 12 |
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| Week 24 |
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| Week 24 |
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