Phase III Insulin Add-On Asia Regional Program - ST

Diabetes Clinical Trial

Official title:

A 24-week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate Efficacy and Safety of Dapagliflozin Added to Therapy of Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096705
• Other study ID #: MB102-137
• Status: Completed
• Phase: Phase 3
• First received: March 24, 2014
• Last updated: December 23, 2016
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationKorea: Food and Drug AdministrationSingapore: Clinical Trials & Epidemiology Research Unit (CTERU)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose is to determine if after 24 weeks of oral daily administration, there will be a greater mean reduction from baseline in glycosylated hemoglobin (HbA1c) achieved with Dapagliflozin 10 mg plus insulin compared to placebo plus insulin in subjects with type 2 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

• Subjects must have type 2 diabetes with inadequate glycemic control, defined as HbA1c = 7.5% and = 11.0% obtained at screening visit

• Subjects must be taking a stable mean dose of = 20 IU injectable insulin daily for at least 8 weeks prior to enrollment

Exclusion Criteria:

• Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment

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

Intervention

Drug:
• Dapagliflozin

• Dapagliflozin Placebo

Locations

Country	Name	City	State
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	Sichuan
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Haerbin	Heilongjiang
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Suzhou	Jiangsu
China	Local Institution	Tianjin
China	Local Institution	Wuxi	Jiangsu
China	Local Institution	Xi An	Shanxi
China	Local Institution	Xi'an	Shanxi
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Daejeon
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Korea, Republic of,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at Week 24		Baseline (Day 1) and 24 weeks	No
Secondary	Change from baseline in Fasting plasma glucose (FPG) at Week 24		Baseline (Day 1) and 24 weeks	No
Secondary	Change from baseline in Body weight at Week 24		Baseline (Day 1) and 24 weeks	No
Secondary	Change from baseline in Absolute calculated mean total daily dose of insulin (TDDI) at Week 24		Baseline (Day 1) and 24 weeks	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form