Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
A 24-week Randomised, Double-blind, Parallel-group, Multi-centre, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
1 other identifier
interventional
261
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes
Started Feb 2011
Shorter than P25 for phase_3 type-2-diabetes
26 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
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
August 23, 2013
CompletedJuly 24, 2014
July 1, 2014
1.1 years
February 10, 2011
January 30, 2013
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
From Baseline to Week 24
Adjusted Mean Change in Body Weight
From Baseline to Week 24
Study Arms (3)
1
EXPERIMENTALDapagliflozin 5 mg
2
EXPERIMENTALDapagliflozin 10 mg
3
PLACEBO COMPARATORInterventions
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 type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization
You may not qualify if:
- Type 1 diabetes mellitus
- FPG \>240 mg/dL before randomization
- 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 (26)
Research Site
Noda, Chiba, Japan
Research Site
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
Related Publications (2)
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.
PMID: 24909293BACKGROUNDNatale 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.
PMID: 38770818DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Eva Johnsson
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 24, 2014
Results First Posted
August 23, 2013
Record last verified: 2014-07