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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to placebo when given in oral doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1mg dapagliflozin |
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| 2 | Experimental | 2.5mg dapagliflozin |
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| 3 | Experimental | 5mg dapagliflozin |
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| 4 | Experimental | 10mg dapagliflozin |
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| 5 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | once daily, 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in HbA1c Levels | The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Fasting Plasma Glucose | Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. | Baseline to Week 12 |
| Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parikh Shamik | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anjyo | Japan | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
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Enrollment: 417; randomized: 279 Study Start Date: August 2009 Study Completion Date: May 2010 Primary Completion Date: May 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | 1mg Dapagliflozin | Dapagliflozin tablet 1 mg once daily |
| FG001 | 2.5mg Dapagliflozin | Dapagliflozin tablet 2.5 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
once daily, 12 weeks |
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Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy |
| At Week 12 |
| Bunkyō City |
| Japan |
| Research Site | Chūōku | Japan |
| Research Site | Daitō | Japan |
| Research Site | Kamagaya | Japan |
| Research Site | Kashiwara | Japan |
| Research Site | Matsuyama | Japan |
| Research Site | Nagoya | Japan |
| Research Site | Naka | Japan |
| Research Site | Nakano | Japan |
| Research Site | Nerima-ku | Japan |
| Research Site | Okinawa | Japan |
| Research Site | Osaka | Japan |
| Research Site | Sapporo | Japan |
| Research Site | Shibuya-ku | Japan |
| Research Site | Shinjyuku-ku | Japan |
| Research Site | Suita | Japan |
| Research Site | Uji | Japan |
| Research Site | Wakayama | Japan |
| Research Site | Yamato | Japan |
| FG002 | 5mg Dapagliflozin | Dapagliflozin tablet 5 mg once daily |
| FG003 | 10mg Dapagliflozin | Dapagliflozin tablet 10 mg once daily |
| FG004 | Placebo | Placebo Comparator |
| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set defined as all randomised participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind period.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1mg Dapagliflozin | Dapagliflozin tablet 1 mg once daily |
| BG001 | 2.5mg Dapagliflozin | Dapagliflozin tablet 2.5 mg once daily |
| BG002 | 5mg Dapagliflozin | Dapagliflozin tablet 5 mg once daily |
| BG003 | 10mg Dapagliflozin | Dapagliflozin tablet 10 mg once daily |
| BG004 | Placebo | Placebo Comparator |
| BG005 | 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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| HBA1C | Mean | Standard Deviation | percent |
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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 in HbA1c Levels | The primary efficacy endpoint is the absolute change in HbA1c from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. | Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | percent | Baseline to Week 12 |
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| Secondary | Adjusted Mean Change in Fasting Plasma Glucose | Change in fasting plasma glucose from baseline to Week 12 or the last post-baseline measurement prior to Week 12, if no Week 12 assessment is available. | Full Analysis Set, participants with non-missing baseline and Week 12 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline to Week 12 |
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| Secondary | Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7% | Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy | Full Analysis Set, participants with non-missing baseline and week 12 (LOCF) values | Posted | Number | Percentage of participants | At Week 12 |
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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 12-week double-blind treatment plus 4/30 days or up to the follow-up visit if earlier.
Participants were questioned at each study visit about the occurrence of any health problems and any examination conducted at the 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 | 1mg Dapagliflozin | Dapagliflozin tablet 1 mg once daily | 2 | 59 | 14 | 59 | ||
| EG001 | 2.5mg Dapagliflozin | Dapagliflozin tablet 2.5 mg once daily | 1 | 56 | 13 | 56 | ||
| EG002 | 5mg Dapagliflozin | Dapagliflozin tablet 5 mg once daily | 2 | 58 | 14 | 58 | ||
| EG003 | 10mg Dapagliflozin | Dapagliflozin tablet 10 mg once daily | 1 | 52 | 13 | 52 | ||
| EG004 | Placebo | Placebo Comparator | 0 | 54 | 14 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| MULTI-ORGAN FAILURE | General disorders | MedDRA 13.0 | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| DERMAL CYST | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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If an efficacy measurement was unavailable at the time point for analysis, last observation was carried forward (LOCF).
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 |
| 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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| Male |
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| Superiority or Other |
| The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided) | ANCOVA | with treatment group (all treatment groups included) as fixed effect and baseline value as covariate. | <0.0001 | significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints. | Mean Difference (Final Values) | -0.45 | Standard Error of the Mean | 0.1009 | 2-Sided | 95 | -0.65 | -0.26 | No | Superiority or Other |
| The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided) | ANCOVA | with treatment group (all treatment groups included) as fixed effect and baseline value as covariate. | <0.0001 | significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints. | Mean Difference (Final Values) | -0.72 | Standard Error of the Mean | 0.0990 | 2-Sided | 95 | -0.92 | -0.53 | No | Superiority or Other |
| The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided) | ANCOVA | with treatment group (all treatment groups included) as fixed effect and baseline value as covariate. | <0.0001 | significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints. | Mean Difference (Final Values) | -0.79 | Standard Error of the Mean | 0.1018 | 2-Sided | 95 | -0.99 | -0.59 | No | Superiority or Other |
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