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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment
All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin (10 mg) | Active Comparator |
| |
| Dapagliflozin (5 mg) | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 10 mg, Once Daily, 104 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, 6, 8, 10, 12, 14, 16, 18, 20, 22, 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, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 in the double-blind period |
Not provided
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 |
|---|---|---|---|---|---|---|
| Vista Medical Research, Inc. | Mesa | Arizona | 85206 | United States | ||
| Valley Research |
| 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. | |
| 27306615 |
| Label | URL |
|---|---|
| Publication | View source |
Not provided
Not provided
Of 631 participants enrolled, 276 completed a qualification period. Of these 276 participants, 252 were randomized and received treatment. Of these 252 participants, 204 completed double-blind treatment period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue) |
| FG001 | Dapagliflozin 5 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Dapagliflozin | Drug | Tablets, Oral, 5 mg, Once Daily, 104 weeks |
|
|
| Placebo | Drug | Tablets, Oral, 0 mg, Once Daily, 104 weeks |
|
| 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 |
| Fresno |
| California |
| 93720 |
| United States |
| Marin Endocrine Care & Research, Inc. | Greenbrae | California | 94904 | United States |
| Office Of Richard Cherlin, Md | Los Gatos | California | 95032 | United States |
| Diabetes Medical Center Of California | Northridge | California | 91325 | United States |
| Apex Research Of Riverside | Riverside | California | 92505 | United States |
| La Biomed At Harbor Ucla Med Ctr. | Torrance | California | 90502 | United States |
| Endocrine Associates Of The Rockies | Denver | Colorado | 80220 | United States |
| Panhandle Family Care Associates | Marianna | Florida | 32446 | United States |
| Genesis Clinical Research | Tampa | Florida | 33614 | United States |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | United States |
| Twin Cities Clinical Research | Brooklyn Center | Minnesota | 55430 | United States |
| Kcva Medical Center Research Svc (151) | Kansas City | Missouri | 64128 | United States |
| Va Nebraska-Western Iowa Health Care System (Nwihcs) | Omaha | Nebraska | 68105 | United States |
| University Of Medicine And Dentistry Of New Jersey | Voorhees Township | New Jersey | 08043 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Slocum-Dickson Medical Group, Pllc | New Hartford | New York | 13413 | United States |
| Community Health Care Of Manchester | Akron | Ohio | 44319 | United States |
| Center For Thyroid Diseases And Endocrinology | Beachwood | Ohio | 44122 | United States |
| Physician Research, Inc. | Zanesville | Ohio | 43701 | United States |
| Univ Of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | United States |
| Rogue Valley Clinical Research | Medford | Oregon | 97504 | United States |
| Drexel University College Of Medicine | Philadelphia | Pennsylvania | 19102 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Low Country Internal Medicine Of Sc, Pa | Charleston | South Carolina | 29406 | United States |
| Carolina Health Specialists | Myrtle Beach | South Carolina | 29572 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| Research Institute Of Dallas | Dallas | Texas | 75231 | United States |
| Westbury Medical Clinic P.A. | Houston | Texas | 77005 | United States |
| The Strelitz Diabetes Center | Norfolk | Virginia | 23510 | United States |
| Capital Clinical Research Center | Olympia | Washington | 98502 | United States |
| Cedar Research Llc | Tacoma | Washington | 98405 | United States |
| Aurora Advanced Healthcare | Milwaukee | Wisconsin | 53209 | United States |
| Zablocki Veterans Affairs Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Local Institution | Buenos Aires | Buenos Aires | C1012AAR | Argentina |
| Local Institution | Buenos Aires | Buenos Aires | C1408INH | Argentina |
| Local Institution | Capital Federal | Buenos Aires | C1405BCJ | Argentina |
| Local Institution | Mar del Plata | Buenos Aires | 7600 | Argentina |
| Local Institution | Zárate | Buenos Aires | 2800 | Argentina |
| Local Institution | Córdoba | Córdoba Province | 5000 | Argentina |
| Local Institution | Córdoba | Córdoba Province | X5006CBI | Argentina |
| Local Institution | Salta | Salta Province | A4406CLA | Argentina |
| Local Institution | Camperdown | New South Wales | 2050 | Australia |
| Local Institution | St Leonards | New South Wales | 2065 | Australia |
| Local Institution | Woollongong | New South Wales | 2500 | Australia |
| Local Institution | Launceston | Tasmania | 7250 | Australia |
| Local Institution | Calgary | Alberta | T3B 0M3 | Canada |
| Local Institution | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Local Institution | Barrie | Ontario | L4M 7G1 | Canada |
| Local Institution | Thornhill | Ontario | L4J 8L7 | Canada |
| Local Institution | Toronto | Ontario | M4N 3M5 | Canada |
| Local Institution | Toronto | Ontario | M4R 2G4 | Canada |
| Local Institution | Gatineau | Quebec | J8V 2P5 | Canada |
| Local Institution | Laval | Quebec | H7T 2P5 | Canada |
| Local Institution | Sherbrooke | Quebec | J1G 5K2 | Canada |
| Local Institution | Regina | Saskatchewan | S4P 0W5 | Canada |
| Local Institution | Copenhagen Nv | 2400 | Denmark |
| Local Institution | Gentofte Municipality | 2820 | Denmark |
| Local Institution | Hvidovre | 2650 | Denmark |
| Local Institution | Besançon | 25030 | France |
| Local Institution | Brest | 29609 | France |
| Local Institution | Paris | 75475 | France |
| Local Institution | Paris | 75877 | France |
| Local Institution | Poitiers | 86021 | France |
| Local Institution | Indore | Madhya Pradesh | 452001 | India |
| Local Institution | Pune | Maharashtra | 411 004 | India |
| Local Institution | Bangalore | 560 052 | India |
| Local Institution | Bangalore | 560034 | India |
| Local Institution | Chennai | 600029 | India |
| Local Institution | Pune, Maharashtra | 411011 | India |
| Local Institution | Rajasthan | 302 001 | India |
| Local Institution | Chieri | 10023 | Italy |
| Local Institution | Chieti Scalo | 66013 | Italy |
| Local Institution | Modena | 41100 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Perugia | 06126 | Italy |
| Local Institution | Pisa | 56126 | Italy |
| Local Institution | Roma | 00189 | Italy |
| Local Institution | Siena | 53100 | Italy |
| Local Institution | Durango | Durango | 34075 | Mexico |
| Local Institution | Celaya | Guanajuato | 38000 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44670 | Mexico |
| Local Institution | Df | Mexico City | 01120 | Mexico |
| Local Institution | Df | Mexico City | 06700 | Mexico |
| Local Institution | Df | Mexico City | 11800 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution | Arequipa | Arequipa | Peru |
| Local Institution | Lima | Lima Province | 18 | Peru |
| Local Institution | Lima | Lima Province | LIMA 13 | Peru |
| Local Institution | Lima Cercado | Lima region | 1 | Peru |
| Local Institution | Caguas | 00725 | Puerto Rico |
| Local Institution | San Juan | 00909 | Puerto Rico |
| Local Institution | Singapore | 119074 | Singapore |
| Local Institution | Barcelona | 08036 | Spain |
| Local Institution | San Sebastian de Los | 28702 | Spain |
| Local Institution | Vizcaya | 48903 | Spain |
| Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjostrom CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15. No abstract available. |
| 24067431 | Derived | Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25. |
| Publication long-term | View source |
| MB102029\_Redacted\_CSR\_synopsis | View source |
Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; 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 (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants who received at least 1 dose of study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received dapagliflozin matching placebo once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue) |
| BG001 | Dapagliflozin 5 mg | Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; 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 (Subjects were to continue their original pre-enrollment anti-diabetic therapy; 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 |
| |||||||||||||||
| Pre-Enrollment Anti-Hyperglycemic Therapy | 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 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, 6, 8, 10, 12, 14, 16, 18, 20, 22, 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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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, 6, 8, 10, 12, 14, 16, 18, 20, 22, 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 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 |
|
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.
Not provided
Not provided
| 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 (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label anti-diabetic therapy as rescue) | 9 | 84 | 39 | 84 | ||
| EG001 | Dapagliflozin 5 mg | Participants received dapagliflozin 5 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue) | 7 | 83 | 45 | 83 | ||
| EG002 | Dapagliflozin 10 mg | Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue) | 12 | 85 | 42 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| CARDIOMYOPATHY | Cardiac disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA Version: 13.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA Version: 13.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA Version: 13.0 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | MedDRA Version: 13.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 13.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| HYPERSENSITIVITY | Immune system disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| TRAUMATIC BRAIN INJURY | Injury, poisoning and procedural complications | MedDRA Version: 13.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| SPONDYLOLISTHESIS | Musculoskeletal and connective tissue disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| TENDON DISORDER | Musculoskeletal and connective tissue disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| BALANOPOSTHITIS | Reproductive system and breast disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| POLLAKIURIA | Renal and urinary disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version: 13.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version: 13.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA Version: 13.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA Version: 13.0 | Systematic Assessment |
|
Not provided
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
Not provided
Not provided
Not provided
| 65 years and older |
|
| Female |
|
| BLACK OR AFRICAN AMERICAN |
|
| ASIAN |
|
| OTHER |
|
| SULFONYLUREA-BASED REGIMEN |
|
| THIAZOLIINEDIONE-BASED REGIMEN |
|
| OTHER REGIMEN |
|
| 0.435 |
Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment |
| Mean Difference (Final Values) |
| -0.11 |
| Standard Error of the Mean |
| 0.1457 |
| 2-Sided |
| 95 |
| -0.40 |
| 0.17 |
| No |
| Superiority or Other |
| OG002 | Dapagliflozin 10 mg | Participants received dapagliflozin 10 mg once daily for up to 24 weeks (Subjects were to continue their original pre-enrollment anti-diabetic therapy; 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 (Subjects were to continue their original pre-enrollment anti-diabetic therapy; may include the addition of open-label metformin as rescue) |
|
|
|