Phase III Insulin Add-On Asia Regional Program - ST

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02096705
First received: March 24, 2014
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: Dapagliflozin
Drug: Dapagliflozin Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change from baseline in HbA1c at Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Fasting plasma glucose (FPG) at Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Body weight at Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Absolute calculated mean total daily dose of insulin (TDDI) at Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Dapagliflozin
Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Drug: Dapagliflozin
Other Name: BMS-512148
Placebo Comparator: Group 2: Dapagliflozin Placebo
Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
Drug: Dapagliflozin Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096705

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 31 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02096705     History of Changes
Other Study ID Numbers: MB102-137
Study First Received: March 24, 2014
Last Updated: September 10, 2014
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014