A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095653
• Other study ID #: MB102-054
• Status: Completed
• Phase: Phase 3
• First received: March 26, 2010
• Last updated: March 20, 2015
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationIndia: Drugs Controller General of IndiaKorea: Food and Drug AdministrationTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 5 mg, Once daily, 24 weeks
• Dapagliflozin
Tablets, Oral, 10 mg, Once daily, 24 weeks
• Metformin
Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
• Dapagliflozin Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing
China	Local Institution	Changchun	Jilin
China	Local Institution	Changsha	Hunan
China	Local Institution	Changsha	Hunan
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Chongqing	Chongqing
China	Local Institution	Guanzhou	Guangdong
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hefei	Anhui
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shenyang	Liaoning
China	Local Institution	Tianjin	Tianjin
China	Local Institution	Wuhan	Hubei
China	Local Institution	Wuhan
China	Local Institution	Wuxi	Jiangsu
China	Local Institution	Xian
India	Local Institution	Bangalore	Karnataka
India	Local Institution	Bangalore
India	Local Institution	Indore	Madhya Pradesh
India	Local Institution	Jaipur
Korea, Republic of	Local Institution	Busanjin-gu
Korea, Republic of	Local Institution	Guri-si
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul	Nowon-GU
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Yung Kang city

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c for each dose of dapagliflozin vs placebo		At Week 24	No
Secondary	Change from baseline in Fasting Plasma Glucose (FPG)		At Week 24	No
Secondary	Change from baseline in 2hr-post meal glucose		At Week 24	No
Secondary	Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0%		At Week 24	No
Secondary	Change from baseline in total body weight		At Week 24	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form