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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this clinical research study is to learn if BMS-512148, added to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can help reduce the blood sugar levels compared to insulin and one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2 diabetes. The safety of this treatment will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 20 mg |
|
| Cohort 2 - Arm 1 | Experimental | 10 mg |
|
| Cohort 2 - Arm 2 | Experimental | 20 mg |
|
| Cohort 2 - Arm 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Tablets, Oral, once daily, up to 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration 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, and 12 in the double-blind period. | From Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 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 |
|---|---|---|---|---|---|---|
| Nea Clinic | Jonesboro | Arkansas | 72401 | United States | ||
| Valley Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19528367 | Result | Wilding JP, Norwood P, T'joen C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment. Diabetes Care. 2009 Sep;32(9):1656-62. doi: 10.2337/dc09-0517. Epub 2009 Jun 15. | |
| 27461213 | Derived |
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Of 163 participants enrolled, Of these 163 participants, 71 were randomized and received treatment. Of these 71 participants, 60 completed double-blind treatment period
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin 20 mg | Tablets, oral, once daily for 12 weeks |
| FG001 | Placebo | Tablets, oral, once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cohort 1 |
|
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| Placebo | Drug | Tablets, Oral, 0 mg, once daily, up to 12 weeks |
|
| From Baseline to Week 12 |
| Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | Therapeutic glycemic response is defined as HbA1c <7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. | From Baseline to Week 12 |
| Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | Therapeutic glycemic response is defined as HbA1c <=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. | From Baseline to Week 12 |
| Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | Therapeutic glycemic response is defined as HbA1c decrease from baseline >= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. | From Baseline to Week 12 |
| Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2 | Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period. | From Baseline to Week 12 |
| Fresno |
| California |
| 93720 |
| United States |
| Bernstein, Richard | Greenbrae | California | 94904 | United States |
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 32205 | United States |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Model Clinical Research Llc | Baltimore | Maryland | 21204 | United States |
| University Of Michigan | Ann Arbor | Michigan | 48109 | United States |
| St. Louis Center For Clinical Research | St Louis | Missouri | 63128 | United States |
| Suny Upstate Medical University | Syracuse | New York | 13210 | United States |
| Mountain Diabetes And Endocrine Center | Asheville | North Carolina | 28801 | United States |
| Your Diabetes Endocrine Nutrition Group | Mentor | Ohio | 44060 | United States |
| Research Institute Of Dallas, P.A. | Dallas | Texas | 75231 | United States |
| Diabetes And Glandular Disease Research Associates, P.A. | San Antonio | Texas | 78229 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98055 | United States |
| Advanced Healthcare S.C. | Milwaukee | Wisconsin | 53209 | United States |
| Local Institution | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Local Institution | Bathurst | New Brunswick | E2A 4X7 | Canada |
| Local Institution | Gatineau | Quebec | J8V 2P5 | Canada |
| Local Institution | Laval | Quebec | H7T 2P5 | Canada |
| Local Institution | Longueuil | Quebec | J4N 1L6 | Canada |
| Local Institution | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Local Institution | Sherbrooke | Quebec | J1G 5K2 | Canada |
| Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3. |
| 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. |
| FG002 | Dapagliflozin 10 mg | Tablets, oral, once daily for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
| Cohort 2 |
|
|
All randomized patients who received at least 1 dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin 20 mg | Tablets, oral, once daily for 12 weeks |
| BG001 | Placebo | Tablets, oral, once daily for 12 weeks |
| BG002 | Dapagliflozin 10 mg | Tablets, 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 Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | HbA1c was measured as percent of hemoglobin by a central laboratory. Data after insulin uptitration 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, and 12 in the double-blind period. | Chort 2 all randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin. | Posted | Mean | Standard Error | % of hemoglobin | From Baseline to Week 12 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | Fasting plasma glucose was measured as milligrams per deciliter(mg/dL) by a central laboratory. Data after insulin uptitration 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. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 1, 2, 4, 6, 8, 10, and 12 in the double-blind period. | Chort 2 all randomized participants who received study medication and had nonmissing FPG values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin. | Posted | Mean | Standard Error | mg/dL | From Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | Therapeutic glycemic response is defined as HbA1c <7.0%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. | Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin. | Posted | Number | Participants | From Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <=6.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | Therapeutic glycemic response is defined as HbA1c <=6.5%. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. | Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin. | Posted | Number | Participants | From Baseline to Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) Decrease From Baseline >= 0.5% at Week 12 (Last Observation Carried Forward [LOCF]) - Cohort 2 | Therapeutic glycemic response is defined as HbA1c decrease from baseline >= 0.5% at Week 12. Data after insulin uptitration was excluded from this analysis. HbA1c was measured as a percent of hemoglobin. | Chort 2 all randomized participants who received study medication and had nonmissing values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin. | Posted | Number | Participants | From Baseline to Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adjusted Mean Total Daily Dose of Insulin (TDDI) Change From Baseline at Week 12 (LOCF), Including Data After Up-titration of Insulin) - Cohort 2 | Baseline TDDI was reduced by 50% prior to treatment, except 2 subjects. TDDI could be up-titrated according to prespecified criteria at Weeks 4, 6, 8, 10 and 12 in the double-blind period. | Chort 2 all randomized participants who received study medication and had nonmissing TDDI values at baseline and Week 12 (LOCF). Note: participants in cohort 1 provided data to establish an acceptable safety and tolerability profile when dapagliflozin 20 mg was added to open-label oral antidiabetic agent plus insulin. | Posted | Mean | Standard Error | units/day | 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 | Dapagliflozin 20 mg | Tablets, oral, once daily for 12 weeks | 1 | 24 | 13 | 24 | ||
| EG001 | Placebo | Tablets, oral, once daily for 12 weeks | 1 | 23 | 12 | 23 | ||
| EG002 | Dapagliflozin 10 mg | Tablets, oral, once daily for 12 weeks | 0 | 24 | 12 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA Version: 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| VULVOVAGINAL MYCOTIC INFECTION | Infections and infestations | MedDRA Version: 11.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA Version: 11.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA Version: 11.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| THIRST | General disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA Version: 11.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA Version: 11.0 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA Version: 11.0 | Systematic Assessment |
|
Cohort 1 data provided information on insulin dose adjustment (n=4).
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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 |
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| Lost to Follow-up |
|
| non-compliance, not met criteria, etc |
|
| Withdrawal by Subject |
|
| 65 years or older |
|
| Female |
|
| Back/African American |
|
| Asian |
|
| Other |
|
| Mean Difference (Final Values) |
| -0.78 |
| Standard Error of the Mean |
| 0.1903 |
| 2-Sided |
| 95 |
| -1.16 |
| -0.40 |
ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups. |
| Superiority or Other |
| Dapagliflozin 20 mg |
Tablets, oral, once daily for 12 weeks |
|
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| Participants |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Counts |
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| Participants |
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