Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01294423
First received: February 10, 2011
Last updated: September 25, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 Type2 diabetes mellitus who have inadequate glycemic control with diet and exercise.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes High Blood Sugar |
Drug: Dapagliflozin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- change in haemoglobin A1c (HbA1c) [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- change in Fasting plasma glucose(FPG) [ Time Frame: From Baseline to Week 24 ] [ Designated as safety issue: No ]
- change in total body weight [ Time Frame: From Baseline to Week24 ] [ Designated as safety issue: No ]
| Enrollment: | 261 |
| Study Start Date: | February 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Dapagliflozin 5 mg
|
Drug: Dapagliflozin
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
|
|
Experimental: 2
Dapagliflozin 10 mg
|
Drug: Dapagliflozin
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
|
| Placebo Comparator: 3 |
Drug: Placebo
Matching placebo for Dapagliflozin 5mg/10mg oral dose
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 randomization
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294423
Locations
| Japan | |
| Research Site | |
| Noda, Chiba, Japan | |
| Research Site | |
| Yukuhashi, Fukuoka, Japan | |
| Research Site | |
| Hiroshima-shi, Hiroshima, Japan | |
| Research Site | |
| Chitose-shi, Hokkaido, Japan | |
| Research Site | |
| Sapporo, Hokkaido, Japan | |
| Research Site | |
| Takasago-shi, Hyogo, Japan | |
| Research Site | |
| Hakusan-shi, Ishikawa, Japan | |
| Research Site | |
| Sanuki-shi, Kagawa, Japan | |
| Research Site | |
| Takamatsu-shi, Kagawa, Japan | |
| Research Site | |
| Ebina-shi, Kanagawa, Japan | |
| Research Site | |
| Kamakura-shi, Kanagawa, Japan | |
| Research Site | |
| Sendai, Miyagi, Japan | |
| Research Site | |
| Sendai-shi, Miyagi, Japan | |
| Research Site | |
| Matsumoto-shi, Nagano, Japan | |
| Research Site | |
| Osaka-shi, Osaka, Japan | |
| Research Site | |
| Suita, Osaka, Japan | |
| Research Site | |
| Otsu-shi, Shiga, Japan | |
| Research Site | |
| Shizuoka-shi, Shizuoka, Japan | |
| Research Site | |
| Chuo, Tokyo, Japan | |
| Research Site | |
| Chuo-ku, Tokyo, Japan | |
| Research Site | |
| Meguro-ku,, Tokyo, Japan | |
| Research Site | |
| Ota-ku, Tokyo, Japan | |
| Research Site | |
| Takaoka-shi, Toyama, Japan | |
| Research Site | |
| Toyama-shi, Toyama, Japan | |
| Research Site | |
| Fukuoka, Japan | |
| Research Site | |
| Okayama, Japan | |
| Research Site | |
| Tokyo, Japan | |
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
| Study Director: | Jisin Yang, MD | AstraZeneca KK |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01294423 History of Changes |
| Other Study ID Numbers: | D1692C00006 |
| Study First Received: | February 10, 2011 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by AstraZeneca:
|
Phase3 Clinical trial Type2 Diabetes Mellitus |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hyperglycemia |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013