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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 improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
| |
| Group 3 | Experimental |
|
| 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 1179 participants enrolled, 514 completed a qualification period. Of these 514 participants, 393 were randomized and received treatment. Of these 393 participants, 343 completed double-blind treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) |
| FG001 | Dapagliflozin 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dapagliflozin | Drug | Tablets, Oral, 10 mg, Once daily, 24 weeks |
|
|
| Metformin | Drug | Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks |
|
|
| Dapagliflozin Placebo | Drug | Tablets, Oral, 0 mg, Once daily, 24 weeks |
|
| From Baseline to Week 24 |
| Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (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 Liquid 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. PLMG 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 |
| Percentage of 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. Percent adjusted for baseline HbA1c. 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. Mean and standard error for percentage of participants were estimated by modified logistic regression model. | From Baseline to Week 24 |
| Beijing |
| Beijing Municipality |
| 100029 |
| China |
| Local Institution | Beijing | Beijing Municipality | 100044 | China |
| Local Institution | Beijing | Beijing Municipality | 100730 | China |
| Local Institution | Beijing | Beijing Municipality | 100853 | China |
| Local Institution | Chongqing | Chongqing Municipality | 40016 | China |
| Local Institution | Guanzhou | Guangdong | 510120 | China |
| Local Institution | Wuhan | Hubei | 430022 | China |
| Local Institution | Changsha | Hunan | 410000 | China |
| Local Institution | Changsha | Hunan | 410008 | China |
| Local Institution | Nanjing | Jiangsu | 210008 | China |
| Local Institution | Nanjing | Jiangsu | 210012 | 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 | 610072 | China |
| Local Institution | Tianjin | Tianjin Municipality | 300211 | China |
| Local Institution | Hangzhou | Zhejiang | 310003 | China |
| Local Institution | Hangzhou | Zhejiang | 310009 | China |
| Local Institution | Beijing | 100034 | China |
| Local Institution | Wuhan | 430030 | China |
| Local Institution | Xi'an | 710032 | China |
| Local Institution | Bangalore | Karnataka | 560043 | India |
| Local Institution | Indore | Madhya Pradesh | 452010 | India |
| Local Institution | Bangalore | 560092 | India |
| Local Institution | Jaipur | 302023 | India |
| Local Institution | Seoul | Nowon-GU | 139-711 | South Korea |
| Local Institution | Busanjin-gu | 633-165 | South Korea |
| Local Institution | Guri-si | 471-701 | South Korea |
| Local Institution | Seoul | 120-752 | South Korea |
| Local Institution | Seoul | 137040 | South Korea |
| Local Institution | Taichung | 402 | Taiwan |
| Local Institution | Taichung | 43303 | Taiwan |
| Local Institution | Taipei | 110 | Taiwan |
| Local Institution | Taipei | 235 | Taiwan |
| Local Institution | Yung Kang City | 71044 | Taiwan |
Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
| FG002 | Dapagliflozin 10 mg | Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) |
| COMPLETED |
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| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) |
| BG001 | Dapagliflozin 5 mg | Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) |
| BG002 | Dapagliflozin 10 mg | Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) |
| BG003 | 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 |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| 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 Liquid Meal Glucose (PLMG) (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 Liquid 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. PLMG measurements were obtained on Day 1 and week 24 in the double-blind period. | All randomized participants who received study medication and had nonmissing PLMG 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 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of 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. Percent adjusted for baseline HbA1c. 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. Mean and standard error for percentage of participants were estimated by modified logistic regression model. | All randomized participants who received study medication and had nonmissing values at baseline and Week 24 (LOCF) | Posted | Mean | Standard Error | Percentage of participants | From Baseline to Week 24 |
|
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 | Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) | 2 | 132 | 38 | 132 | ||
| EG001 | Dapagliflozin 5 mg | Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) | 5 | 128 | 28 | 128 | ||
| EG002 | Dapagliflozin 10 mg | Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) | 4 | 133 | 23 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYLORIC STENOSIS | Congenital, familial and genetic disorders | MedDRA Version: 15.0 | Systematic Assessment |
| |
| GOITRE | Endocrine disorders | MedDRA Version: 15.0 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA Version: 15.0 | Systematic Assessment |
| |
| URETHRITIS | Infections and infestations | MedDRA Version: 15.0 | Systematic Assessment |
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| LACUNAR INFARCTION | Nervous system disorders | MedDRA Version: 15.0 | Systematic Assessment |
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| CEREBRAL INFARCTION | Nervous system disorders | MedDRA Version: 15.0 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA Version: 15.0 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA Version: 15.0 | Systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA Version: 15.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA Version: 15.0 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA Version: 15.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version: 15.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA Version: 15.0 | Systematic Assessment |
| |
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA Version: 15.0 | 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 |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| 65 to younger than 75 years |
|
| 75 years and older |
|
| Female |
|
| CHINESE |
|
| JAPANESE |
|
| KOREAN |
|
| ASIAN OTHER |
|
| <0.0001 |
Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment |
| Mean Difference (Final Values) |
| -0.82 |
| Standard Error of the Mean |
| 0.0962 |
| 2-Sided |
| 95 |
| -1.01 |
| -0.63 |
| No |
| Superiority or Other |
| Dapagliflozin 10 mg |
Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) |
|
|
|
Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) |
|
|
|
| OG002 | Dapagliflozin 10 mg | Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue) |
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