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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dapagliflozin | Experimental | Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin |
|
| Group 2: Dapagliflozin Placebo | Placebo Comparator | Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in HbA1c From Baseline to Week 24 | The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm. | Baseline (Day 1) and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL). | Baseline (Day 1) and 24 weeks |
| Adjusted Mean Change in Body Weight From Baseline to Week 24 |
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Inclusion Criteria:
Inclusion criteria for randomization:
HbA1c ≥ 7.5 and ≤ 10.5% at Day -14
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Beijing | Beijing Municipality | 100029 | China | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38770818 | Derived | Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2. |
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477 participants were enrolled; 313 entered lead-in period; 272 participants were randomized to a treatment group. Of the 205 participants not randomized to a treatment group: 190 No longer met study criteria, 11 withdrew consent, 2 were lost to follow-up, and 2 were removed for administrative reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin |
| FG001 | Dapagliflozin | Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Dapagliflozin Placebo | Drug | Tablet |
|
Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg). |
| Baseline (Day 1) and 24 weeks |
| Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24 | The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU). | Baseline (Day 1) and 24 weeks |
| Beijing |
| Beijing Municipality |
| 100700 |
| China |
| Local Institution | Beijing | Beijing Municipality | 100730 | China |
| Local Institution | Guangzhou | Guangdong | 510080 | 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 | 210012 | China |
| Local Institution | Suzhou | Jiangsu | 215004 | China |
| Local Institution | Wuxi | Jiangsu | 214023 | China |
| Local Institution | Changchun | Jilin | 130041 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200040 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200072 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200080 | China |
| Local Institution | Shanghai | Shanghai Municipality | 200092 | China |
| Local Institution | Xi’an | Shanxi | 710032 | China |
| Local Institution | Xi’an | Shanxi | 710061 | China |
| Local Institution | Chengdu | Sichuan | 610072 | China |
| Local Institution | Chongqing | Sichuan | 400010 | China |
| Local Institution | Beijing | 100039 | China |
| Local Institution | Tianjin | China |
| Local Institution | Singapore | 169856 | Singapore |
| Local Institution | Singapore | 529889 | Singapore |
| Local Institution | Busan | 49241 | South Korea |
| Local Institution | Daegu | 42415 | South Korea |
| Local Institution | Daejeon | 35233 | South Korea |
| Local Institution | Seoul | 06351 | South Korea |
| Local Institution | Seoul | 134-727 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up |
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All Randomized Participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin |
| BG001 | Dapagliflozin | Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 in HbA1c From Baseline to Week 24 | The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm. | All randomized participants with non-missing baseline and at least one post-baseline value | Posted | Mean | Standard Error | percentage of hemoglobin | Baseline (Day 1) and 24 weeks |
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| Secondary | Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL). | All randomized participants with non-missing baseline and at least one post-baseline value | Posted | Mean | Standard Error | mg/dL | Baseline (Day 1) and 24 weeks |
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| Secondary | Adjusted Mean Change in Body Weight From Baseline to Week 24 | Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg). | All randomized participants with non-missing baseline and at least one post-baseline value | Posted | Mean | Standard Error | kilograms | Baseline (Day 1) and 24 weeks |
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| Secondary | Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24 | The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU). | All randomized participants with non-missing baseline and at least one post-baseline value | Posted | Mean | Standard Error | International Units (IU) | Baseline (Day 1) and 24 weeks |
|
|
24 week treatment period + 30 days
Includes serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 30 days. Includes non-serious adverse events with onset on or after the first date/time of double-blind treatment and on or prior to the last day of double blind treatment plus 4 days.
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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 | Dapagliflozin | Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin | 8 | 139 | 61 | 139 | ||
| EG001 | Placebo | Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin | 18 | 133 | 61 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
| |
| MYOCARDIAL BRIDGING | Congenital, familial and genetic disorders | MedDRA (18.1) | Systematic Assessment |
| |
| CATARACT | Eye disorders | MedDRA (18.1) | Systematic Assessment |
| |
| UVEITIS | Eye disorders | MedDRA (18.1) | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
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| LUNG INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| NEUROSYPHILIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| ACIDOSIS | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
| |
| FOOT DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| PERIARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
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| BILE DUCT CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
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| COLORECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
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| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
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| ARACHNOID CYST | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| DIABETIC NEUROPATHY | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| SEIZURE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| VIITH NERVE PARALYSIS | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
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| ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA (18.1) | Systematic Assessment |
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| CALCULUS URETERIC | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Maria Langkilde | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Subjects not reporting status |
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| >=65 years |
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| Male |
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