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Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes, High Blood Sugar

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Dapagliflozin
Dapagliflozin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Phase3, Clinical trial, Type2 Diabetes Mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 type 2 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Dapagliflozin 5 mg

Dapagliflozin 10 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adjusted Mean Change in Fasting Plasma Glucose (FPG)
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Adjusted Mean Change in Body Weight
To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Full Information

First Posted
February 10, 2011
Last Updated
July 17, 2014
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01294423
Brief Title
Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, High Blood Sugar
Keywords
Phase3, Clinical trial, Type2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Dapagliflozin 5 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for Dapagliflozin 5mg/10mg oral dose
Primary Outcome Measure Information:
Title
Adjusted Mean Change in HbA1c Levels
Description
To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Time Frame
From Baseline to Week 24
Secondary Outcome Measure Information:
Title
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
Description
To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Time Frame
From Baseline to Week 24
Title
Adjusted Mean Change in Body Weight
Description
To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.
Time Frame
From Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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 type 2 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jisin Yang, MD
Organizational Affiliation
AstraZeneca KK
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Noda
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Yukuhashi
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Chitose-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Takasago-shi
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Hakusan-shi
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Sanuki-shi
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Ebina-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kamakura-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Matsumoto-shi
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Otsu-shi
State/Province
Shiga
Country
Japan
Facility Name
Research Site
City
Shizuoka-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Chuo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Meguro-ku,
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Takaoka-shi
State/Province
Toyama
Country
Japan
Facility Name
Research Site
City
Toyama-shi
State/Province
Toyama
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Okayama
Country
Japan
Facility Name
Research Site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24909293
Citation
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.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=298&filename=CSR-D1692C00006.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=298&filename=CSR-D1692C00006.pdf
Description
CSR-D1692C00006.pdf
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=298&filename=D1692C00006_Clinical_Study_Protocol_and_Amendment_8536419317510300265.pdf
Description
D1692C00006_Clinical_Study_Protocol_and_Amendment

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Evaluate Efficacy and Safety in Japanese Subjects With Type 2 Diabetes Mellitus

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