- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972244
Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
August 9, 2013 updated by: AstraZeneca
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Trial to Evaluate the Efficacy and Safety of Dapagliflozin as Monotherapy in Japanese Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
417
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Anjyo, Japan
- Research Site
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Bunkyo-ku, Japan
- Research Site
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Chuo-ku, Japan
- Research Site
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Daito, Japan
- Research Site
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Kamagaya, Japan
- Research Site
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Kashiwara, Japan
- Research Site
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Matsuyama, Japan
- Research Site
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Nagoya, Japan
- Research Site
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Naka, Japan
- Research Site
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Nakano-ku, Japan
- Research Site
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Nerima-ku, Japan
- Research Site
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Okinawa, Japan
- Research Site
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Osaka, Japan
- Research Site
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Sapporo, Japan
- Research Site
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Shibuya-ku, Japan
- Research Site
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Shinjyuku-ku, Japan
- Research Site
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Suita, Japan
- Research Site
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Uji, Japan
- Research Site
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Wakayama, Japan
- Research Site
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Yamato, Japan
- Research Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Japanese Subjects with type 2 diabetes mellitus.
- Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
- Provision of informed consent.
Exclusion Criteria:
- Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
- The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 5
Placebo
|
once daily, 12 weeks
|
Experimental: 1
1mg dapagliflozin
|
once daily, 12 weeks
|
Experimental: 2
2.5mg dapagliflozin
|
once daily, 12 weeks
|
Experimental: 3
5mg dapagliflozin
|
once daily, 12 weeks
|
Experimental: 4
10mg dapagliflozin
|
once daily, 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Mean Change in HbA1c Levels
Time Frame: Baseline to Week 12
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjusted Mean Change in Fasting Plasma Glucose
Time Frame: Baseline to Week 12
|
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%
Time Frame: At Week 12
|
Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy
|
At Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Parikh Shamik, AstraZeneca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
August 31, 2009
First Submitted That Met QC Criteria
September 3, 2009
First Posted (Estimate)
September 4, 2009
Study Record Updates
Last Update Posted (Estimate)
October 14, 2013
Last Update Submitted That Met QC Criteria
August 9, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1692C00005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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