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| Name | Class |
|---|---|
| Astra Zeneca, Bristol-Myers Squibb | OTHER |
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The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on TZD alone. The safety of this treatment will also be studied
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, 5.0 mg, once daily, up to 48 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 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), 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. PPG measurements were obtained on Day 1 and week 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 |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, Llc | Anniston | Alabama | 36207 | United States | ||
| Iicr |
| 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. | |
| 33368935 |
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Of 972 participants enrolled, 558 completed a qualification period. Before entering lead-in period, 344 participants entered dose optimization period and 263 completed. A total of 480 participants entered the lead-in period, 420 randomized and received treatment, 367 completed double-blind treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | PLACEBO + Pioglitazone | Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
| FG001 | Dapagliflozin 5MG + Pioglitazone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dapagliflozin | Drug | Tablets, Oral, 10.0 mg, once daily, up to 48 weeks |
|
|
| Placebo matching Dapagliflozin | Drug | Tablets, Oral, 0 mg, once daily, up to 48 weeks |
|
| Thiazolidinedione (Pioglitazone) | Drug | Tablets, ≥ 30 mg, Once daily, up to 48 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 |
| 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. | 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 |
| Adjusted Mean Change From Baseline in Waist Circumference (cm) 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 waist circumference 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. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period. | From Baseline to Week 24 |
| Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 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 among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 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 |
| Ozark |
| Alabama |
| 36360 |
| United States |
| 43rd Medical Associates, P.C. | Phoenix | Arizona | 85051 | United States |
| Clinical Research Advantage Inc / Desert Clinical Res, Llc | Tempe | Arizona | 85282 | United States |
| Clinical Research Advantage, Inc | Tempe | Arizona | 85282 | United States |
| Little Rock Family Practice Clinic | Little Rock | Arkansas | 72205 | United States |
| Searcy Medical Center | Searcy | Arkansas | 72143 | United States |
| Clinical Innovations, Inc. | Costa Mesa | California | 92626 | United States |
| Marin Endocrine Care And Research, Inc. | Greenbrae | California | 94904 | United States |
| Torrance Clinical Research | Lomita | California | 90717 | United States |
| Randall Shue, D.O. | Los Angeles | California | 90023 | United States |
| Diabetes Medical Center Of California | Northridge | California | 91325 | United States |
| Desert Medical Advances | Palm Desert | California | 92260 | United States |
| Avastra Clinical Trials | Redlands | California | 92373 | United States |
| Sierra Clinical Research | Roseville | California | 95661 | United States |
| Ritchken & First M.D.'S | San Diego | California | 92117 | United States |
| Advantage Clinical Research | Santa Ana | California | 92701 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Diabetes Research Center | Tustin | California | 92780 | United States |
| Aurora Family Medicine Center, P.C. | Aurora | Colorado | 80012 | United States |
| Denver Internal Medicine | Denver | Colorado | 80209 | United States |
| Central Florida Clinical Trials | Altamonte Springs | Florida | 32701 | United States |
| Health First Clinical Research Group, Inc. | Chipley | Florida | 32428 | United States |
| Clinical Therapeutics Corporation | Coral Gables | Florida | 33134 | United States |
| Westside Center For Clinical Research | Jacksonville | Florida | 32205 | United States |
| Panhandle Family Care Associates | Marianna | Florida | 32446 | United States |
| Baptist Diabetes Associates, Pa | Miami | Florida | 33156 | United States |
| Suncoast Clinical Res Inc. | New Port Richey | Florida | 34652 | United States |
| Stone Mountain Clinical Research | Stone Mountain | Georgia | 30088 | United States |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Northwest Indiana Center For Clinical Research | Valparaiso | Indiana | 46383 | United States |
| Professional Research Network Of Kansas | Wichita | Kansas | 67203 | United States |
| St. Mary'S Center For Diabetes And Endocrinology | Grand Rapids | Michigan | 49503 | United States |
| Endocrine Research Associates | Jackson | Mississippi | 39216 | United States |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | United States |
| Danny W. Jackson P.A. | Rolling Fork | Mississippi | 39159 | United States |
| Association Of International Professionals | Las Vegas | Nevada | 89101 | United States |
| Physicians Research Center | Toms River | New Jersey | 08755 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Metrolina Internal Medicine | Charlotte | North Carolina | 28204 | United States |
| The Center For Nutrition & Preventive Medicine, Pllc | Charlotte | North Carolina | 28277 | United States |
| Northstate Clinical Research | Lenoir | North Carolina | 28645 | United States |
| New Hanover Medical Research | Wilmington | North Carolina | 28401 | United States |
| Providence Health Partners - Center For Clinical Research | Dayton | Ohio | 45439 | United States |
| Physician Research, Inc. | Zanesville | Ohio | 43701 | United States |
| Family Medical Associates | Levittown | Pennsylvania | 19056 | United States |
| Banksville Medical, Pc | Pittsburgh | Pennsylvania | 15216 | United States |
| Brookside Family Practice & Pediatrics | Pottstown | Pennsylvania | 19464 | United States |
| Columbia Clinical Research, Inc. | Columbia | South Carolina | 29201 | United States |
| Southeastern Research Associates, Inc. | Taylors | South Carolina | 29687 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Dallas Diabetes & Endocrine Center | Dallas | Texas | 75230 | United States |
| Village Family Practice | Houston | Texas | 77024 | United States |
| Office Of Dr. Michelle Zaniewski Singh | Houston | Texas | 77090 | United States |
| Diabetes & Glandular Disease Research Assoc,, Inc. | San Antonio | Texas | 78229 | United States |
| Tidewater Integrated Medical Research | Virginia Beach | Virginia | 23454 | United States |
| William L. Gray, Md | Spokane | Washington | 99216 | United States |
| Local Institution | Buenos Aires | Buenos Aires | B1708IFF | Argentina |
| Local Institution | Ciudad Auton | Buenos Aires | C1408INH | Argentina |
| Local Institution | Zárate | Buenos Aires | 2800 | Argentina |
| Local Institution | Córdoba | Córdoba Province | 5000 | Argentina |
| Local Institution | Winnipeg | Manitoba | R3K 0Y8 | Canada |
| Local Institution | Moncton | New Brunswick | E1G 1A7 | Canada |
| Local Institution | Mount Pearl | Newfoundland and Labrador | A1N 1W7 | Canada |
| Local Institution | Halifax | Nova Scotia | B3K 5R3 | Canada |
| Local Institution | Sarnia | Ontario | N7T 4X3 | Canada |
| Local Institution | Toronto | Ontario | M8V 3X8 | Canada |
| Local Institution | Mirabel | Quebec | J7J 2K8 | Canada |
| Local Institution | Hariyāna | 132001 | India |
| Local Institution | Mumbai | 400007 | India |
| Local Institution | Vellore | 632004 | India |
| Local Institution | Chihuahua City | Chihuahua | 31020 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44100 | Mexico |
| Local Institution | Guadalajara | Jalisco | 44670 | Mexico |
| Local Institution | Zapopan | Jalisco | 45200 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64240 | Mexico |
| Local Institution | Monterrey, Nl | Nuevo León | 64400 | Mexico |
| Local Institution | Veracruz | Veracruz | 91700 | Mexico |
| Local Institution | Mérida | Yucatán | 97210 | Mexico |
| Local Institution | Lima | Lima Province | 09 | Peru |
| Local Institution | Lima | Lima Province | 17 | Peru |
| Local Institution | Lima | Lima Province | 31 | Peru |
| Local Institution | Cebu City | 6000 | Philippines |
| Local Institution | Manila | 1000 | Philippines |
| Local Institution | Pasig | 1600 | Philippines |
| Local Institution | Ponce | 00717 | Puerto Rico |
| Local Institution | Changhua | 500 | Taiwan |
| Local Institution | Taichung | 43303 | Taiwan |
| Local Institution | Taipei | 110 | Taiwan |
| Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25. |
| 26894924 | Derived | Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19. |
| 22446170 | Derived | Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012 Jul;35(7):1473-8. doi: 10.2337/dc11-1693. Epub 2012 Mar 23. |
Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks
| FG002 | Dapagliflozin 10MG + Pioglitazone | Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized patients who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PLACEBO + Pioglitazone | Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
| BG001 | Dapagliflozin 5MG + Pioglitazone | Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
| BG002 | Dapagliflozin 10MG + Pioglitazone | Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 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 |
| ||||||||||||||||
| Gender | Count of Participants | 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 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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline in 120-minute Post-challenge Plasma Glucose (PPG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) | Secondary endpoints were tested using sequential testing procedure and are presented in hierarchical order. In post oral glucose tolerance test (OGTT), 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. PPG measurements were obtained on Day 1 and week 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 | 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 | 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 | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline in Waist Circumference (cm) 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 waist circumference 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. Waist circumference measurements were obtained during the qualification and lead-in periods and on Day 1 and Week 24 of the double-blind period. | All randomized participants who received study medication and had nonmissing waist circumference values at baseline and Week 24 (LOCF) | Posted | Mean | Standard Error | cm | From Baseline to Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline in Total Body Weight (kg) Among Subjects With Baseline Body Mass Index (BMI) ≥ 27 kg/m^2 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 among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 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) among subjects with baseline body mass index (BMI) ≥ 27 kg/m^2 | 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 + Pioglitazone | Placebo tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks | 1 | 139 | 37 | 139 | ||
| EG001 | Dapagliflozin 5MG + Pioglitazone | Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks | 4 | 141 | 34 | 141 | ||
| EG002 | Dapagliflozin 10MG + Pioglitazone | Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks | 2 | 140 | 45 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA Version: 12.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA Version: 12.1 | Systematic Assessment |
| |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version: 12.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA Version: 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DYSLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version: 12.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version: 12.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA Version: 12.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA Version: 12.1 | 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 |
| C089946 | 2,4-thiazolidinedione |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| 65 to younger than 75 years |
|
| 75 years and older |
|
| Male |
|
| Black/African American |
|
| White |
|
| Other |
|
| <0.0001 |
Primary endpoints were tested at alpha=0.027 applying Dunnett's adjustment |
| Mean Difference (Final Values) |
| -0.55 |
| Standard Error of the Mean |
| 0.1175 |
| 2-Sided |
| 95 |
| -0.78 |
| -0.31 |
| No |
| Superiority or Other |
| Dapagliflozin 10MG + Pioglitazone |
Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
|
|
|
| OG002 | Dapagliflozin 10MG + Pioglitazone | Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
|
|
|
| Dapagliflozin 10MG + Pioglitazone |
Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
|
|
|
|
|
|
| OG002 | Dapagliflozin 10MG + Pioglitazone | Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
|
|
|
Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
| OG002 | Dapagliflozin 10MG + Pioglitazone | Dapagliflozin tablets, oral, once daily, up to 48 weeks plus pioglitazone tablets, ≥ 30 mg, once daily up to 48 weeks |
|
|
|