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Phase III Insulin Add-On Asia Regional Program - ST

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ClinicalTrials.gov Identifier: NCT02096705
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : March 6, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Dapagliflozin Drug: Dapagliflozin Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : March 31, 2014
Actual Primary Completion Date : January 28, 2016
Actual Study Completion Date : January 28, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1: Dapagliflozin
Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Drug: Dapagliflozin
Tablet
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
Tablet



Primary Outcome Measures :
  1. Adjusted Mean 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 :
  1. Adjusted Mean 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).

  2. Adjusted Mean 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).

  3. Adjusted Mean 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion criteria for randomization:

HbA1c ≥ 7.5 and ≤ 10.5% at Day -14

Exclusion Criteria:

  • Treatment with more than two oral antidiabetic (OAD) agents within 6 weeks of Enrollment
  • History of diabetic ketoacidosis of hyperosmolar nonketotic coma
  • Clinically diagnosed Type 1 diabetes mellitus
  • Congestive heart failure defined as New York Heart Association (NYHA) stage III and IV
  • Severe uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mmHg
  • History of unstable or rapidly progressing renal disease
  • History of severe hepatobiliary disease
  • Mallingancy within 5 years of the screening/enrollment visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096705


  Show 29 Study Locations
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02096705     History of Changes
Other Study ID Numbers: MB102-137
First Posted: March 26, 2014    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: August 9, 2017
Last Verified: July 2017

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