Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus
A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
1 other identifier
interventional
728
1 country
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2011
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
September 16, 2013
CompletedDecember 17, 2013
November 1, 2013
1.6 years
February 10, 2011
July 10, 2013
November 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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
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
Other Outcomes (2)
Mean Change in HbA1c Levels
Baseline to Week 52
Mean Change in Body Weight
Baseline to Week 52
Study Arms (1)
Open label treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedures
- Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)
- diagnosed with type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started
You may not qualify if:
- Type 1 diabetes mellitus,
- FPG \>240 mg/dL before treatment started
- Subjects who have history of unstable or rapidly progressing renal disease
- Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
- Significant cardiovascular history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (38)
Research Site
Nagoya, Aichi-ken, Japan
Research Site
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
In the efficacy analysis, for participants who did not complete 52-week treatment period LOCF (last observation carried forward) was used.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Dr Jisin Yang, MD
AstraZeneca KK
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
February 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 17, 2013
Results First Posted
September 16, 2013
Record last verified: 2013-11