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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Oral Dose 5 or 10 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Adverse Events | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events | Long-term treatment up to 52 weeks |
| Proportion of Participants With Serious Adverse Events | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events | Long-term treatment up to 52 weeks |
| Proportion of Participants With At Least One Episode of Hypoglycemia | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia | Long-term treatment up to 52 weeks |
| Mean Change in Hematocrit | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit | Baseline to Week 52 |
| Mean Change in Alanine Aminotransferase (ALT) | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in HbA1c Levels | To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c | Baseline to Week 52 |
| Mean Change in Body Weight |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Jisin Yang, MD | AstraZeneca KK | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nagoya | Aichi-ken | Japan | |||
| Research Site |
A 6-week wash-out period was applicable only for subjects with ongoing anti-diabetic treatment at enrolment. A 4-week lead-in period was applicable for all subjects.
First subject enrolled: 28-Feb-2011; Last subject last visit: 15-Sep-2012; 1030 participants were enrolled in 56 Japanese centers. 728 Japanese men and women aged >=20 years with inadequate glycemic control (HbA1c levels of 6.5% to 10.0% prior to study treatment) with diet and exercise were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Monotherapy | Dapagliflozin 5/10 mg only |
| FG001 | All Combination Therapies | Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 52 |
| Mean Change in Aspartate Aminotransferase (AST) | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase | Baseline to Week 52 |
| Mean Change in Blood Urea Nitrogen (BUN) | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen | Baseline to Week 52 |
| Mean Change in Magnesium | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L) | Baseline to Week 52 |
| Mean Change in Serum Uric Acid | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid | Baseline to Week 52 |
| Mean Change in Seated Heart Rate | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse | Baseline to Week 52 |
| Mean Change in Seated Diastolic Blood Pressure | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure | Baseline to Week 52 |
| Mean Change in Seated Systolic Blood Pressure | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure | Baseline to Week 52 |
To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight |
| Baseline to Week 52 |
| Owariasahi |
| Aichi-ken |
| Japan |
| Research Site | Toyohashi | Aichi-ken | Japan |
| Research Site | Hirosaki | Aomori | Japan |
| Research Site | Niihama | Ehime | Japan |
| Research Site | Fukuoka | Fukuoka | Japan |
| Research Site | Itoshima | Fukuoka | Japan |
| Research Site | Yukuhashi | Fukuoka | Japan |
| Research Site | Annaka | Gunma | Japan |
| Research Site | Ōta | Gunma | Japan |
| Research Site | Aki-gun | Hiroshima | Japan |
| Research Site | Hiroshima | Hiroshima | Japan |
| Research Site | Sapporo | Hokkaido | Japan |
| Research Site | Sanuki | Kagawa-ken | Japan |
| Research Site | Takamatsu | Kagawa-ken | Japan |
| Research Site | Kamakura | Kanagawa | Japan |
| Research Site | Kawasaki | Kanagawa | Japan |
| Research Site | Yokohama | Kanagawa | Japan |
| Research Site | Zushi | Kanagawa | Japan |
| Research Site | Kochi | Kochi | Japan |
| Research Site | Sendai | Miyagi | Japan |
| Research Site | Matsumoto | Nagano | Japan |
| Research Site | Osaka | Osaka | Japan |
| Research Site | Suita | Osaka | Japan |
| Research Site | Ōtsu | Shiga | Japan |
| Research Site | Atami | Shizuoka | Japan |
| Research Site | Shizuoka | Shizuoka | Japan |
| Research Site | Komatsushimachō | Tokushima | Japan |
| Research Site | Chiyoda City | Tokyo | Japan |
| Research Site | Chūō | Tokyo | Japan |
| Research Site | Mitaka | Tokyo | Japan |
| Research Site | Ōta-ku | Tokyo | Japan |
| Research Site | Shibuya City | Tokyo | Japan |
| Research Site | Shinjuku | Tokyo | Japan |
| Research Site | Taitō City | Tokyo | Japan |
| Research Site | Takaoka | Toyama | Japan |
| Research Site | Toyama | Toyama | Japan |
| Research Site | Ube | Yamaguchi | Japan |
| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set included all subjects who received at least one dose of study medication and who provided any safety records.
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| ID | Title | Description |
|---|---|---|
| BG000 | Monotherapy | Dapagliflozin 5/10 mg only |
| BG001 | All Combination Therapies | Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs |
| 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| 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 |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Seated Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| HbA1c | Mean | Standard Deviation | Percent |
| |||||||||||||||
| Fasting Plasma Glucose (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 | Proportion of Participants With Adverse Events | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events | Safety Analysis Set | Posted | Number | Percentage of participants | Long-term treatment up to 52 weeks |
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| Primary | Proportion of Participants With Serious Adverse Events | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events | Safety Analysis Set | Posted | Number | Percentage of participants | Long-term treatment up to 52 weeks |
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| ||||||||||||||||||||||||||||||
| Primary | Proportion of Participants With At Least One Episode of Hypoglycemia | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia | Safety Analysis Set | Posted | Number | Percentage of participants | Long-term treatment up to 52 weeks |
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| Primary | Mean Change in Hematocrit | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Error | Percent | Baseline to Week 52 |
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| Primary | Mean Change in Alanine Aminotransferase (ALT) | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Error | U/L | Baseline to Week 52 |
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| Primary | Mean Change in Aspartate Aminotransferase (AST) | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Error | U/L | Baseline to Week 52 |
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| Primary | Mean Change in Blood Urea Nitrogen (BUN) | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Error | mg/dL | Baseline to Week 52 |
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| Primary | Mean Change in Magnesium | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L) | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Error | mEq/L | Baseline to Week 52 |
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| Primary | Mean Change in Serum Uric Acid | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Error | mg/dL | Baseline to Week 52 |
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| Primary | Mean Change in Seated Heart Rate | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline to Week 52 |
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| Primary | Mean Change in Seated Diastolic Blood Pressure | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Deviation | mmHg | Baseline to Week 52 |
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| Primary | Mean Change in Seated Systolic Blood Pressure | To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure | Safety Analysis Set, participants with non-missing baseline and week 52 values | Posted | Mean | Standard Deviation | mmHg | Baseline to Week 52 |
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| Other Pre-specified | Mean Change in HbA1c Levels | To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c | Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value | Posted | Mean | 95% Confidence Interval | Percent | Baseline to Week 52 |
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| Other Pre-specified | Mean Change in Body Weight | To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight | Full Analysis Set, participants with non-missing baseline and week 52 (LOCF) value | Posted | Mean | 95% Confidence Interval | kg | Baseline to Week 52 |
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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 52-week open-label 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 | Monotherapy | Dapagliflozin 5/10 mg only | 14 | 249 | 71 | 249 | ||
| EG001 | All Combination Therapies | Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs | 15 | 479 | 126 | 479 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGE RELATED MACULAR DEGENERATION | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| CATARACT | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| RETINAL DETACHMENT | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| COLONIC POLYP | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| GASTROINTESTINAL INFLAMMATION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| CHRONIC SINUSITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| LOBAR PNEUMONIA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| BRAIN STEM HAEMORRHAGE | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| LIMB TRAUMATIC AMPUTATION | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| TACHYCARDIA PAROXYSMAL | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| ELECTROCARDIOGRAM ABNORMAL | Investigations | MedDRA 15.0 | Systematic Assessment |
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| CALCULUS URINARY | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| POLLAKIURIA | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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In the efficacy analysis, for participants who did not complete 52-week treatment period LOCF (last observation carried forward) was used.
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 |
|---|---|
| D006943 | Hyperglycemia |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| 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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