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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT #: 2009-010221-39 |
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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 kidney function, as assessed by glomerular filtration rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental |
| |
| Hydrochlorothiazide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 10 mg, once daily, 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF]) | 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. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory. | From Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during lead-in, 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 |
|---|---|---|---|---|---|---|
| Advanced Clinical Res Inst | Anaheim | California | 92801 | United States | ||
| Torrance Clinical Research |
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| Label | URL |
|---|---|
| Publication | View source |
| MB102035\_Redacted\_CSR\_synopsis | View source |
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Of 154 participants enrolled, 77 completed a qualification period. Of these 77 participants, 75 were randomized and received treatment. Of these 75 participants, 74 completed double-blind treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Tablet, oral, once daily for 12 weeks |
| FG001 | Dapagliflozin 10 mg | Tablet, oral, once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Tablets, Oral, 0 mg, once daily, 12 weeks |
|
| Hydrochlorothiazide | Drug | Tablets, Oral, 25 mg, once daily, 12 weeks |
|
| From Baseline to Week 12 |
| Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during lead-in, and Week 12 in the double-blind period. | From Baseline to Week 12 |
| Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during lead-in, and Week 12 in the double-blind period. | From Baseline to Week 12 |
| Lomita |
| California |
| 90717 |
| United States |
| Elite Research Institute | Miami | Florida | 33169 | United States |
| Compass Research, Llc | Orlando | Florida | 32806 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| University Of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Prism Research | Saint Paul | Minnesota | 55114 | United States |
| Memorial Hospital Of Rhode Island | Pawtucket | Rhode Island | 02860 | United States |
| Zablocki Veterans Affairs Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Local Institution | Toronto | Ontario | M4G 3E8 | Canada |
| Local Institution | Laval | Quebec | H7T 2P5 | Canada |
| Local Institution | Groningen | 9713 GZ | Netherlands |
| FG002 |
| Hydrochlorothiazide 25 mg |
Tablet, oral, once daily for 12 weeks |
| 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 | Tablet, oral, once daily for 12 weeks |
| BG001 | Dapagliflozin 10 mg | Tablet, oral, once daily for 12 weeks |
| BG002 | Hydrochlorothiazide 25 mg | Tablet, oral, once daily for 12 weeks |
| 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 |
|
| 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 Percent Change From Baseline in Glomerular Filtration Rate (GFR) at Week 12 (Modified Last Observation Carried Forward [MLOCF]) | 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. If no Week 12 measurement was available, the last available post-baseline measurement obtained on or after Day 23 was used regardless of rescue medication. Measurements were obtained during radomization visit, and Week 12 in the double-blind period by a central laboratory. | All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (MLOCF) | Posted | Mean | Standard Error | % Change of Baseline GFR | From Baseline to Week 12 |
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| Secondary | Adjusted Mean Change From Baseline in 24-Hour Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during lead-in, and Week 12 in the double-blind period. | All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF) | Posted | Mean | Standard Error | mmHg | From Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline in Daytime (0900 to 2100 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during lead-in, and Week 12 in the double-blind period. | All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF) | Posted | Mean | Standard Error | mmHg | From Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline in Nighttime (0100 to 0600 Hours) Ambulatory Systolic Blood Pressure (ASBP) at Week 12 (Last Observation Carried Forward [LOCF]) | 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. Measurements were obtained during lead-in, and Week 12 in the double-blind period. | All randomized participants who received study medication and had nonmissing ASBP values at baseline and Week 12 (LOCF) | Posted | Mean | Standard Error | mmHg | 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 | Tablet, oral, once daily for 12 weeks | 0 | 25 | 2 | 25 | ||
| EG001 | Dapagliflozin 10 mg | Tablet, oral, once daily for 12 weeks | 3 | 24 | 6 | 24 | ||
| EG002 | Hydrochlorothiazide 25 mg | Tablet, oral, once daily for 12 weeks | 0 | 26 | 9 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LOCALISED INFECTION | Infections and infestations | MedDRA Version: 13.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC INJURY | Injury, poisoning and procedural complications | MedDRA Version: 13.1 | Systematic Assessment |
| |
| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| POLLAKIURIA | Renal and urinary disorders | MedDRA Version: 13.1 | Systematic Assessment |
| |
| NOCTURIA | Renal and urinary disorders | MedDRA Version: 13.1 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA Version: 13.1 | Systematic Assessment |
| |
| INGROWING NAIL | Skin and subcutaneous tissue disorders | MedDRA Version: 13.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA Version: 13.1 | Systematic Assessment |
| |
| MALAISE | Metabolism and nutrition disorders | MedDRA Version: 13.1 | 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 |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 65 - 75 years |
|
| Female |
|
| Black/African American |
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| Asian |
|
| Other |
|
| Mean Difference (Final Values) |
| -7.62 |
| Standard Error of the Mean |
| 2.7068 |
| 2-Sided |
| 95 |
| -12.87 |
| -2.06 |
ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed. |
| No |
| Superiority or Other |
| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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