Phase III Insulin Add-On Asia Regional Program - ST

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Dapagliflozin Placebo

• Study Type: Interventional
• Enrollment (Actual): 477
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100039
    • Local Institution
  • Tianjin, China
    • Local Institution
  • Beijing
    • Beijing, Beijing, China, 100730
      • Local Institution
    • Beijing, Beijing, China, 100029
      • Local Institution
    • Beijing, Beijing, China, 100700
      • Local Institution
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Local Institution
    • Guangzhou, Guangdong, China, 510120
      • Local Institution
  • Heilongjiang
    • Haerbin, Heilongjiang, China, 150001
      • Local Institution
  • Hunan
    • Changsha, Hunan, China, 410008
      • Local Institution
    • Changsha, Hunan, China, 410000
      • Local Institution
  • Jiangsu
    • Nanjing, Jiangsu, China, 210012
      • Local Institution
    • Suzhou, Jiangsu, China, 215004
      • Local Institution
    • Wuxi, Jiangsu, China, 214023
      • Local Institution
  • Jilin
    • Changchun, Jilin, China, 130041
      • Local Institution
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Local Institution
    • Shanghai, Shanghai, China, 200040
      • Local Institution
    • Shanghai, Shanghai, China, 200072
      • Local Institution
    • Shanghai, Shanghai, China, 200092
      • Local Institution
  • Shanxi
    • Xi An, Shanxi, China, 710032
      • Local Institution
    • Xi'an, Shanxi, China, 710061
      • Local Institution
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Local Institution
    • Chongqing, Sichuan, China, 400010
      • Local Institution
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Local Institution
  • Daegu, Korea, Republic of, 42415
    • Local Institution
  • Daejeon, Korea, Republic of, 35233
    • Local Institution
  • Seoul, Korea, Republic of, 06351
    • Local Institution
  • Seoul, Korea, Republic of, 134-727
    • Local Institution
• Singapore
  • Singapore, Singapore, 169856
    • Local Institution
  • Singapore, Singapore, 529889
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Dapagliflozin; Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin	Drug: Dapagliflozin; Tablet; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Mean Change in HbA1c From Baseline to Week 24	The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.	Baseline (Day 1) and 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24	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).	Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Body Weight From Baseline to Week 24	Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).	Baseline (Day 1) and 24 weeks
Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24	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).	Baseline (Day 1) and 24 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2014
• Primary Completion (Actual): January 28, 2016
• Study Completion (Actual): January 28, 2016

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: MB102-137