Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972244
• Other study ID #: D1692C00005
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2009
• Last updated: August 9, 2013
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: August 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
once daily, 12 weeks
• Placebo
once daily, 12 weeks

Locations

Country	Name	City	State
Japan	Research Site	Anjyo
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Daito
Japan	Research Site	Kamagaya
Japan	Research Site	Kashiwara
Japan	Research Site	Matsuyama
Japan	Research Site	Nagoya
Japan	Research Site	Naka
Japan	Research Site	Nakano-ku
Japan	Research Site	Nerima-ku
Japan	Research Site	Okinawa
Japan	Research Site	Osaka
Japan	Research Site	Sapporo
Japan	Research Site	Shibuya-ku
Japan	Research Site	Shinjyuku-ku
Japan	Research Site	Suita
Japan	Research Site	Uji
Japan	Research Site	Wakayama
Japan	Research Site	Yamato

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Change in HbA1c Levels	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	No
Secondary	Adjusted Mean Change in Fasting Plasma Glucose	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	No
Secondary	Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%	Proportion of participants achieving therapeutic glycemic response defined as glycosylated hemoglobin <7%, after 12 weeks of double-blind therapy	At Week 12	No