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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dapagliflozin 5 mg |
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| 2 | Experimental | Dapagliflozin 10 mg |
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| 3 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in HbA1c Levels | To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. | From Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Mean Change in Fasting Plasma Glucose (FPG) | To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. | From Baseline to Week 24 |
| Adjusted Mean Change in Body Weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jisin Yang, MD | AstraZeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Noda | Chiba | Japan | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24909293 | Background | Kaku K, Kiyosue A, Inoue S, Ueda N, Tokudome T, Yang J, Langkilde AM. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab. 2014 Nov;16(11):1102-10. doi: 10.1111/dom.12325. Epub 2014 Jul 8. | |
| 38770818 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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Wash-out period was applicable only for participants with ongoing anti-diabetic treatment at enrolment. Drug-naive participants skip the period and directly proceed to a placebo lead-in period.
First participant enrolled: 25 Feb 2011. Last participant completed 24 week period: 12 Mar 2012. 354 participant were enrolled in 30 Japanese centers. 261 participants were randomized. Japanese men or women aged >= 20 years with inadequate glycemic control (HbA1c 6.5% to 10.0%) with diet and exercise.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin 5 mg | Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose |
| FG001 | Dapagliflozin 10 mg | Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dapagliflozin |
| Drug |
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose |
|
| Placebo | Drug | Matching placebo for Dapagliflozin 5mg/10mg oral dose |
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To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. |
| From Baseline to Week 24 |
| Fukuoka |
| Fukuoka |
| Japan |
| Research Site | Yukuhashi | Fukuoka | Japan |
| Research Site | Hiroshima | Hiroshima | Japan |
| Research Site | Chitose-shi | Hokkaido | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Takasago-shi | Hyōgo | Japan |
| Research Site | Hakusan-shi | Ishikawa-ken | Japan |
| Research Site | Sanuki-shi | Kagawa-ken | Japan |
| Research Site | Takamatsu | Kagawa-ken | Japan |
| Research Site | Ebina-shi | Kanagawa | Japan |
| Research Site | Kamakura-shi | Kanagawa | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Matsumoto-shi | Nagano | Japan |
| Research Site | Okayama | Okayama-ken | Japan |
| Research Site | Osaka | Osaka | Japan |
| Research Site | Suita | Osaka | Japan |
| Research Site | Ōtsu | Shiga | Japan |
| Research Site | Shizuoka | Shizuoka | Japan |
| Research Site | Chuo-ku | Tokyo | Japan |
| Research Site | Chūō | Tokyo | Japan |
| Research Site | Meguro-ku, | Tokyo | Japan |
| Research Site | Ōta-ku | Tokyo | Japan |
| Research Site | Tokyo | Tokyo | Japan |
| Research Site | Takaoka-shi | Toyama | Japan |
| Research Site | Toyama | Toyama | Japan |
| 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. |
| CSR-D1692C00006.pdf | View source |
| D1692C00006\_Clinical\_Study\_Protocol\_and\_Amendment | View source |
| FG002 | Placebo | Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose |
| 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 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 treatment period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin 5 mg | Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose |
| BG001 | Dapagliflozin 10 mg | Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose |
| BG002 | Placebo | Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose |
| BG003 | 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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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | 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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| Seated Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| HbA1c | Mean | Standard Deviation | Percent |
| |||||||||||||||
| FPG | Mean | Standard Deviation | mg/dL |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adjusted Mean Change in HbA1c Levels | To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | Percent | From Baseline to Week 24 |
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| Secondary | Adjusted Mean Change in Fasting Plasma Glucose (FPG) | To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | From Baseline to Week 24 |
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| Secondary | Adjusted Mean Change in Body Weight | To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. | Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values | Posted | Least Squares Mean | 95% Confidence Interval | kg | From Baseline to Week 24 |
|
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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 period plus 4/30 days or up to follow-up visit 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 | Dapagliflozin 5 mg | Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose | 0 | 86 | 11 | 86 | ||
| EG001 | Dapagliflozin 10 mg | Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose | 1 | 88 | 15 | 88 | ||
| EG002 | Placebo | Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose | 1 | 87 | 14 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
| |
| PUTAMEN HAEMORRHAGE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to rescue medication were used for outcome measures except for total body weight which was evaluated regardless of 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 |
| D006943 | Hyperglycemia |
| 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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| 65 - <75 years |
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| >= 75 years |
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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 = 0.027 applying Dunnett's adjustment, two-sided) | ANCOVA | with treatment group (all treatment groups included) and gender as effect and baseline value as covariate. | <0.0001 | significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints. | Mean Difference (Final Values) | -0.39 | Standard Error of the Mean | 0.0851 | 2-Sided | 95 | -0.56 | -0.23 | No | Superiority or Other |
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