Clinical trial NCT01095653: A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Asian 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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca, Bristol-Myers Squibb
First posted: 2010-03-30
Enrollment: 1179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in Asian patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years old, with type 2 diabetes and with inadequate glycemic control
* Drug naive or treated with anti-diabetic medication for \< 24 weeks
* C-peptide ≥ 1.0 ng/mL
* Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

* AST and/or ALT \> 3 times ULN
* Serum total bilirubin \> 2 mg/dL
* Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
* Creatine kinase ≥ 3 times ULN
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
Secondary outcomes:
measure: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
measure: Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
measure: Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
measure: Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])
timeFrame: From Baseline to Week 24
Other outcomes:
Locations:
city: Hefei
country: China
facility: Local Institution
state: Anhui
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Chongqing
country: China
facility: Local Institution
state: Chongqing
city: Guanzhou
country: China
facility: Local Institution
state: Guangdong
city: Wuhan
country: China
facility: Local Institution
state: Hubei
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Wuxi
country: China
facility: Local Institution
state: Jiangsu
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Shenyang
country: China
facility: Local Institution
state: Liaoning
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Tianjin
country: China
facility: Local Institution
state: Tianjin
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Beijing
country: China
facility: Local Institution
city: Wuhan
country: China
facility: Local Institution
city: Xian
country: China
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Indore
country: India
facility: Local Institution
state: Madhya Pradesh
city: Bangalore
country: India
facility: Local Institution
city: Jaipur
country: India
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
state: Nowon-GU
city: Busanjin-gu
country: Korea, Republic of
facility: Local Institution
city: Guri-si
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Yung Kang city
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: