Clinical trial NCT01294423: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
High Blood Sugar
Keywords: Phase3
Clinical trial
Type2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2011-02-11
Enrollment: 261
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Adjusted Mean Change in HbA1c Levels
timeFrame: From Baseline to Week 24
Secondary outcomes:
measure: Adjusted Mean Change in Fasting Plasma Glucose (FPG)
timeFrame: From Baseline to Week 24
measure: Adjusted Mean Change in Body Weight
timeFrame: From Baseline to Week 24
Other outcomes:
Locations:
city: Noda
country: Japan
facility: Research Site
state: Chiba
city: Yukuhashi
country: Japan
facility: Research Site
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Chitose-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Takasago-shi
country: Japan
facility: Research Site
state: Hyogo
city: Hakusan-shi
country: Japan
facility: Research Site
state: Ishikawa
city: Sanuki-shi
country: Japan
facility: Research Site
state: Kagawa
city: Takamatsu-shi
country: Japan
facility: Research Site
state: Kagawa
city: Ebina-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Matsumoto-shi
country: Japan
facility: Research Site
state: Nagano
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Suita
country: Japan
facility: Research Site
state: Osaka
city: Otsu-shi
country: Japan
facility: Research Site
state: Shiga
city: Shizuoka-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Meguro-ku,
country: Japan
facility: Research Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Research Site
state: Tokyo
city: Takaoka-shi
country: Japan
facility: Research Site
state: Toyama
city: Toyama-shi
country: Japan
facility: Research Site
state: Toyama
city: Fukuoka
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca KK
name: Jisin Yang, MD
role: STUDY_DIRECTOR
References:
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.