Skip to main content
OpenTrials
Completed

NCT Number: NCT02096705

Phase III Insulin Add-On Asia Regional Program - ST

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

Tablet

Other names: BMS-512148

Dapagliflozin Placebo

Drug

Tablet

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 26, 2014
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.