Clinical trial NCT01294436: Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus
Official title: A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type2 Diabetes
High Blood Sugar
Keywords: Phase3
Clinical trial
Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2011-02-11
Enrollment: 728
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.


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 type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started

Exclusion Criteria:

* Type 1 diabetes mellitus,
* FPG \>240 mg/dL before treatment started
* 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: Proportion of Participants With Adverse Events
timeFrame: Long-term treatment up to 52 weeks
measure: Proportion of Participants With Serious Adverse Events
timeFrame: Long-term treatment up to 52 weeks
measure: Proportion of Participants With At Least One Episode of Hypoglycemia
timeFrame: Long-term treatment up to 52 weeks
measure: Mean Change in Hematocrit
timeFrame: Baseline to Week 52
measure: Mean Change in Alanine Aminotransferase (ALT)
timeFrame: Baseline to Week 52
measure: Mean Change in Aspartate Aminotransferase (AST)
timeFrame: Baseline to Week 52
measure: Mean Change in Blood Urea Nitrogen (BUN)
timeFrame: Baseline to Week 52
measure: Mean Change in Magnesium
timeFrame: Baseline to Week 52
measure: Mean Change in Serum Uric Acid
timeFrame: Baseline to Week 52
measure: Mean Change in Seated Heart Rate
timeFrame: Baseline to Week 52
measure: Mean Change in Seated Diastolic Blood Pressure
timeFrame: Baseline to Week 52
measure: Mean Change in Seated Systolic Blood Pressure
timeFrame: Baseline to Week 52
Secondary outcomes:
Other outcomes:
measure: Mean Change in HbA1c Levels
timeFrame: Baseline to Week 52
measure: Mean Change in Body Weight
timeFrame: Baseline to Week 52
Locations:
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Owariasahi
country: Japan
facility: Research Site
state: Aichi
city: Toyohashi
country: Japan
facility: Research Site
state: Aichi
city: Hirosaki
country: Japan
facility: Research Site
state: Aomori
city: Niihama
country: Japan
facility: Research Site
state: Ehime
city: Itoshima
country: Japan
facility: Research Site
state: Fukuoka
city: Yukuhashi
country: Japan
facility: Research Site
state: Fukuoka
city: Annaka
country: Japan
facility: Research Site
state: Gunma
city: OTA
country: Japan
facility: Research Site
state: Gunma
city: Aki-gun
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Sanuki
country: Japan
facility: Research Site
state: Kagawa
city: Takamatsu
country: Japan
facility: Research Site
state: Kagawa
city: Kamakura
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohamashi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Research Site
state: Kanagawa
city: Zushi
country: Japan
facility: Research Site
state: Kanagawa
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Matsumoto
country: Japan
facility: Research Site
state: Nagano
city: Suita
country: Japan
facility: Research Site
state: Osaka
city: Otsu
country: Japan
facility: Research Site
state: Shiga
city: Atami
country: Japan
facility: Research Site
state: Shizuoka
city: Komatsushima
country: Japan
facility: Research Site
state: Tokushima
city: Chiyoda
country: Japan
facility: Research Site
state: Tokyo
city: Chuo
country: Japan
facility: Research Site
state: Tokyo
city: Mitaka
country: Japan
facility: Research Site
state: Tokyo
city: OTA
country: Japan
facility: Research Site
state: Tokyo
city: Shibuya
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Taito
country: Japan
facility: Research Site
state: Tokyo
city: Takaoka
country: Japan
facility: Research Site
state: Toyama
city: UBE
country: Japan
facility: Research Site
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca KK
name: Dr Jisin Yang, MD
role: STUDY_DIRECTOR
References: