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Phase III Insulin Add-On Asia Regional Program - ST

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02096705
First received: March 24, 2014
Last updated: January 13, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 in HbA1c From Baseline to Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ]
    The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ]
    The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).

  • Change in Body Weight From Baseline to Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ]
    Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).

  • Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24 [ Time Frame: Baseline (Day 1) and 24 weeks ]
    The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).


Enrollment: 477
Study Start Date: March 2014
Study Completion Date: February 2016
Primary Completion Date: February 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 29 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02096705     History of Changes
Other Study ID Numbers: MB102-137
Study First Received: March 24, 2014
Results First Received: January 13, 2017
Last Updated: January 13, 2017

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2017