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| Name | Class |
|---|---|
| Astra Zeneca, Bristol-Myers Squibb | OTHER |
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The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 5 mg, once daily, 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during the randomization visit and Week 12 in the double-blind period. | From Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during the randomization visit and Week 12 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 |
|---|---|---|---|---|---|---|
| Va San Diego Healthcare System | San Diego | California | 92161 | United States | ||
| Pennington Biomedical Research Center |
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| Label | URL |
|---|---|
| Publication | View source |
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Of 116 participants enrolled, 50 completed a qualification period. Of these 50 participants, 44 were randomized and received treatment. Of these 44 participants, 42 completed double-blind treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Background Anti-Diabetes Medication | Placebo tablets, oral, once daily, 12 weeks |
| FG001 | Dapagliflozin 5 mg + Background Anti-Diabetes Medication | Dapagliflozin tablets, oral, once daily, 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least 1 dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Background Anti-Diabetes Medication | Placebo tablets, oral, once daily, 12 weeks |
| BG001 | Dapagliflozin 5 mg + Background Anti-Diabetes Medication | Dapagliflozin tablets, oral, once daily, 12 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 |
| 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 Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during the randomization visit and Week 12 in the double-blind period. | All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF) | Posted | Mean | Standard Error | % Change of Baseline Insulin Sensitivity | From Baseline to Week 12 |
|
Onset on or after the first date of double-blind treatment and on or prior to the last day of double-blind treatment 12 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 + Background Anti-Diabetes Medication | Placebo tablets, oral, once daily, 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA Version: 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Maria Langkilde | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo | Drug | Tablets, Oral, 0 mg, Once daily, 12 weeks |
|
| From Baseline to Week 12 |
| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| Temple University General Clinical Research Center | Philadelphia | Pennsylvania | 19140 | United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex/Gender, Customized | Number | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG001 | Dapagliflozin 5 mg + Background Anti-Diabetes Medication | Dapagliflozin tablets, oral, once daily, 12 weeks |
|
|
|
| Secondary | Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during the randomization visit and Week 12 in the double-blind period. | All randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF) | Posted | Mean | Standard Error | mU/L*min | From Baseline to Week 12 |
|
|
|
|
| 0 |
| 21 |
| 8 |
| 21 |
| EG001 | Dapagliflozin 5 mg + Background Anti-Diabetes Medication | Dapagliflozin tablets, oral, once daily, 12 weeks | 0 | 23 | 9 | 23 |
| INFUSION SITE PAIN | General disorders | MedDRA Version: 13.0 | Systematic Assessment |
|
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA Version: 13.0 | Systematic Assessment |
|
| POLLAKIURIA | Renal and urinary disorders | MedDRA Version: 13.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA Version: 13.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA Version: 13.0 | Systematic Assessment |
|
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 13.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA Version: 13.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |