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| Name | Class |
|---|---|
| AstraZeneca, Bristol-Myers Squibb | UNKNOWN |
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The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
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| Group 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 5 mg, Once daily, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) | HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period. | From Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hefei | Anhui | 230022 | China | ||
| Local Institution |
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| Label | URL |
|---|---|
| Publication | View source |
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Of 1484 patients enrolled, 554 completed a qualification period. Of these 554 patients, 444 were randomized and received treatment. Of these 444 participants, 409 completed the double-blind treatment period
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Metformin | |
| FG001 | Dapagliflozin 5 mg + Metformin | |
| FG002 | Dapagliflozin 10 mg + Metformin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dapagliflozin | Drug | Tablets, Oral, 10 mg, Once daily, 24 weeks |
|
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| Metformin | Drug | Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks |
|
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| Dapagliflozin Placebo | Drug | Tablets, Oral, 0 mg, Once daily, 24 weeks |
|
| Pioglitazone | Drug | Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks |
|
| From Baseline to Week 24 |
| Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PMG measurements were obtained on Day 1 and week 24 in the double-blind period. | From Baseline to Week 24 |
| Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. | From Baseline to Week 24 |
| Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Percentage of participants were estimated by modified logistic regression model, adjusted for baseline HbA1c. | From Baseline to Week 24 |
| Beijing |
| Beijing Municipality |
| 100001 |
| China |
| Local Institution | Beijing | Beijing Municipality | 100029 | China |
| Local Institution | Beijing | Beijing Municipality | 100044 | China |
| Local Institution | Beijing | Beijing Municipality | 100700 | China |
| Local Institution | Beijing | Beijing Municipality | 100730 | China |
| Local Institution | Chongqing | Chongqing Municipality | 400016 | China |
| Local Institution | Guangzhou | Guangdong | 510120 | China |
| Local Institution | Haerbin | Heilongjiang | 150001 | China |
| Local Institution | Changsha | Hunan | 410000 | China |
| Local Institution | Changsha | Hunan | 410008 | China |
| Local Institution | Nanjing | Jiangsu | 210006 | China |
| Local Institution | Nanjing | Jiangsu | 210008 | China |
| Local Institution | Wuxi | Jiangsu | 214023 | China |
| Local Institution | Changchun | Jilin | 130041 | China |
| Local Institution | Shenyang | Liaoning | 110003 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200003 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200040 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200065 | China |
| Local Institution | Chengdu | Sichuan | 610070 | China |
| Local Institution | Chongqing | Sichuan | 400010 | China |
| Local Institution | Tianjin | Tianjin Municipality | 300211 | China |
| Local Institution | Hangzhou | Zhejiang | 310009 | China |
| Local Institution | Xi'an | 710032 | China |
| Local Institution | Bangalore | Karnataka | 560 043 | India |
| Local Institution | Indore | Madhya Pradesh | 452010 | India |
| Local Institution | Bangalore | 560092 | India |
| Local Institution | Jaipur | 302023 | India |
| Local Institution | Vellore, Tamilnadu | 632004 | India |
| Local Institution | Seoul | Nowon-Gu | 139-711 | South Korea |
| Local Institution | Busan | 614-735 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 137-040 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants who received at least 1 dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Metformin | |
| BG001 | Dapagliflozin 5 mg + Metformin | |
| BG002 | Dapagliflozin 10 mg + Metformin | |
| BG003 | 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 |
| |||||||||||||||
| Age, Customized | Number | Participants |
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| Sex/Gender, Customized | Number | Participants |
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| Race/Ethnicity, Customized | 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 | Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) | HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 4, 8, 12, 16, 20, and 24 in the double-blind period. | All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24 (LOCF) | Posted | Mean | Standard Error | % of hemoglobin | From Baseline to Week 24 |
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| Secondary | Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 in the double-blind period. | All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24 (LOCF) | Posted | Mean | Standard Error | mg/dL | From Baseline to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline in 2-hour Post Meal Glucose (PMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Post Meal Glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PMG measurements were obtained on Day 1 and week 24 in the double-blind period. | All randomized participants who received study medication and had nonmissing PMG values at baseline and Week 24 (LOCF) | Posted | Mean | Standard Error | mg/dL | From Baseline to Week 24 |
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| Secondary | Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Adjusted mean change from baseline in total body weight at Week 24 (or the last postbaseline measurement prior to Week 24 if no Week 24 assessment was available was determined. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 8, 12, 16, 20, and 24 of the double-blind period. | All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24 (LOCF) | Posted | Mean | Standard Error | kg | From Baseline to Week 24 |
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| Secondary | Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. Percentage of participants were estimated by modified logistic regression model, adjusted for baseline HbA1c. | All randomized participants who received study medication and had nonmissing HbA1C values at Week 24 (LOCF) | Posted | Number | Percentage of Participants | From Baseline to Week 24 |
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Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 24 weeks plus 4 days for non-serious adverse event; plus 30 days for serious adverse event.
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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 + Metformin | 6 | 145 | 34 | 145 | |||
| EG001 | Dapagliflozin 5 mg + Metformin | 3 | 147 | 43 | 147 | |||
| EG002 | Dapagliflozin 10 mg + Metformin | 3 | 152 | 42 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA Version: 16.0 | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA Version: 16.0 | Systematic Assessment |
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| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA Version: 16.0 | Systematic Assessment |
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| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 16.0 | Systematic Assessment |
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| INFLAMMATORY PSEUDOTUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 16.0 | Systematic Assessment |
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| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 16.0 | Systematic Assessment |
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| LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 16.0 | Systematic Assessment |
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| ANGINA UNSTABLE | Cardiac disorders | MedDRA Version: 16.0 | Systematic Assessment |
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| MYOCARDIAL BRIDGING | Congenital, familial and genetic disorders | MedDRA Version: 16.0 | Systematic Assessment |
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| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA Version: 16.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA Version: 16.0 | Systematic Assessment |
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| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA Version: 16.0 | Systematic Assessment |
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| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA Version: 16.0 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 16.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA Version: 16.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA Version: 16.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version: 16.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version: 16.0 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA Version: 16.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Maria Langkilde | AstraZeneca | ClinicalTrialTransparency@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 |
|---|---|
| C529054 | dapagliflozin |
| D008687 | Metformin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 65 to younger than 75 years |
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| 75 years and older |
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| Female |
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| Chinese |
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| Korean |
|
| <0.0001 |
Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment. |
| Mean Difference (Final Values) |
| -0.62 |
| Standard Error of the Mean |
| 0.0865 |
| 2-Sided |
| 95 |
| -0.79 |
| -0.45 |
| Superiority or Other |
| Units |
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| Counts |
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| Participants |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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