Clinical trial NCT01095666: A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
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: 1484
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 help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 to 77 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 Meal Glucose (PMG) (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: 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: Beijing
country: China
facility: Local Institution
state: Beijing
city: Chongqing
country: China
facility: Local Institution
state: Chongqing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Haerbin
country: China
facility: Local Institution
state: Heilongjiang
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: Chongqing
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: Xi'An
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: Vellore, Tamilnadu
country: India
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
state: Nowon-Gu
city: Busan
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
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: