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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294423
• Other study ID #: D1692C00006
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2011
• Last updated: July 17, 2014
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• High Blood Sugar
• Hyperglycemia
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
• Dapagliflozin
Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
• Placebo
Matching placebo for Dapagliflozin 5mg/10mg oral dose

Locations

Country	Name	City	State
Japan	Research Site	Chitose-shi	Hokkaido
Japan	Research Site	Chuo	Tokyo
Japan	Research Site	Chuo-ku	Tokyo
Japan	Research Site	Ebina-shi	Kanagawa
Japan	Research Site	Fukuoka
Japan	Research Site	Hakusan-shi	Ishikawa
Japan	Research Site	Hiroshima-shi	Hiroshima
Japan	Research Site	Kamakura-shi	Kanagawa
Japan	Research Site	Matsumoto-shi	Nagano
Japan	Research Site	Meguro-ku,	Tokyo
Japan	Research Site	Noda	Chiba
Japan	Research Site	Okayama
Japan	Research Site	Osaka-shi	Osaka
Japan	Research Site	Ota-ku	Tokyo
Japan	Research Site	Otsu-shi	Shiga
Japan	Research Site	Sanuki-shi	Kagawa
Japan	Research Site	Sapporo	Hokkaido
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Sendai-shi	Miyagi
Japan	Research Site	Shizuoka-shi	Shizuoka
Japan	Research Site	Suita	Osaka
Japan	Research Site	Takamatsu-shi	Kagawa
Japan	Research Site	Takaoka-shi	Toyama
Japan	Research Site	Takasago-shi	Hyogo
Japan	Research Site	Tokyo
Japan	Research Site	Toyama-shi	Toyama
Japan	Research Site	Yukuhashi	Fukuoka

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	From Baseline to Week 24	No
Secondary	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.	From Baseline to Week 24	No

External Links

•   Link
•   CSR-D1692C00006.pdf
•   D1692C00006_Clinical_Study_Protocol_and_Amendment