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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin 10 mg tablet | Experimental |
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| matching placebo tablet | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapagliflozin | Drug | 10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period |
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| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in HbA1c Levels | To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea. | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change From Baseline in FPG | To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo | Baseline to week 24 |
| Adjusted Mean Change From Baseline in Total Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Johnsson, PhD, Medical Science Director | AstraZeneca R&D, Global Medicines Development CVGI, SE-431 83 Mölndal, Sweden | Study Director |
| Stephan Matthaei, Prof.Dr.med | Diabetes-Zentrum Quakenbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Edmonton | Alberta | Canada | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25592197 | Derived | Matthaei S, Bowering K, Rohwedder K, Grohl A, Parikh S; Study 05 Group. Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized, double-blind clinical trial. Diabetes Care. 2015 Mar;38(3):365-72. doi: 10.2337/dc14-0666. Epub 2015 Jan 15. |
| Label | URL |
|---|---|
| D1693C00005.pdf | View source |
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During enrollment, diet and life-style advice was given to participants and was reinforced during a placebo lead-in period. Dose of anti-hyperglycemic combination therapy of metformin >= 1500 mg/day and maximum tolerated dose which must be at least half the maximum dose of sulfonylurea for at least 8 weeks prior to enrollment were to remain stable.
First participant enrolled: 24 Oct 2011. Last participant completed 24 week period: 07 Jan 2013. 311 participants were enrolled, 219 were randomized in 45 centers in 5 European countries and in North America. Men and women aged >= 18 years with inadequate glycemic control (HbA1c 7.0% to 10.5% prior to randomization).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Plus Metformin Plus Sulfonylurea | Placebo once daily plus background combination of metformin and sulfonylurea |
| FG001 | Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo | Drug | matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period |
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To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo
| Baseline to week 24 |
| Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) | To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo | Baseline to week 24 |
| Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure | To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo | Baseline to week 8 |
| Winnipeg |
| Manitoba |
| Canada |
| Research Site | St. John's | Newfoundland and Labrador | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Sydney Mines | Nova Scotia | Canada |
| Research Site | Brampton | Ontario | Canada |
| Research Site | Etobicoke | Ontario | Canada |
| Research Site | Markham | Ontario | Canada |
| Research Site | Smiths Falls | Ontario | Canada |
| Research Site | Kensington | Prince Edward Island | Canada |
| Research Site | Laval | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Beroun | Czechia |
| Research Site | České Budějovice | Czechia |
| Research Site | Jílové u Prahy | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Semily | Czechia |
| Research Site | Vyškov | Czechia |
| Research Site | Aßlar | Germany |
| Research Site | Berlin | Germany |
| Research Site | Dresden | Germany |
| Research Site | Falkensee | Germany |
| Research Site | Neuwied | Germany |
| Research Site | Pirna | Germany |
| Research Site | Kielce | Poland |
| Research Site | Lodz | Poland |
| Research Site | Lublin | Poland |
| Research Site | Poznan | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Zgierz | Poland |
| Research Site | Banská Bystrica | Slovakia |
| Research Site | Košice | Slovakia |
| Research Site | Považská Bystrica | Slovakia |
| Research Site | Rimavská Sobota | Slovakia |
| Research Site | Barcelona | Catalonia | Spain |
| Research Site | Santa Coloma de Gramanet (bcn) | Catalu?a | Spain |
| Research Site | A Coruña | Galicia | Spain |
| Research Site | Oviedo | Principality of Asturias | Spain |
| Research Site | A Coruña | Spain |
| Research Site | Barcelona | Spain |
| Research Site | Oviedo | Spain |
| Research Site | Santa Coloma de Gramenet (bcn) | Spain |
Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of study medication during the 24-week short-term double blind treatment period who have a non-missing baseline value and at least one post-baseline value for at least one efficacy variable to be analyzed at week 24.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Plus Metformin Plus Sulfonylurea | Placebo once daily plus background combination of metformin and sulfonylurea |
| BG001 | Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Body Weight | Mean | Standard Deviation | kg |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Glycosylated hemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percent |
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| Fasting Plasma Glucose | Mean | Standard Deviation | mg/dL |
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| Fasting C-Peptide | Mean | Standard Deviation | ng/mL |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Adjusted Mean Change From Baseline in HbA1c Levels | To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea. | Full Analysis Set, participants with non-missing baseline and week 24 values | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline to week 24 |
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| Secondary | Adjusted Mean Change From Baseline in FPG | To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo | Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline to week 24 |
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| Secondary | Adjusted Mean Change From Baseline in Total Body Weight | To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo | Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | kg | Baseline to week 24 |
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| Secondary | Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) | To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo | Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of participants | Baseline to week 24 |
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| Secondary | Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure | To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo | Full Analysis Set, participants with non-missing baseline and week 8 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Baseline to week 8 |
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Non-serious / serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment plus 4/30 days or up to follow-up visit if earlier, or up to and including the start date of extension period if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at a study visit was assessed in comparison to the status at study entry.
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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 Plus Metformin Plus Sulfonylurea | Placebo once daily plus background combination of metformin and sulfonylurea | 6 | 109 | 7 | 109 | ||
| EG001 | Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea | Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea | 1 | 109 | 5 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| aortic valve stenosis | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| arrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| diabetic gangrene | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| sympathetic posterior cervical syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| calculus ureteric | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
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| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| peripheral arterial occlusive disease | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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For participants who did not complete 8 and/or 24 weeks, respectively, last observation carried forward (LOCF) was used for analyses of secondary endpoints. All endpoints were evaluated by excluding data after rescue.
If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Johnsson | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| 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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| Black/African American |
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| Asian |
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| Other |
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