Phase III Insulin Add-On Asia Regional Program - ST

Phase 3

Completed

• Conditions: Diabetes
• Interventions: Drug: Dapagliflozin; Drug: Dapagliflozin Placebo

• Registration Number: NCT02096705
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-26
• Study Start: 2014-03-31
• Primary Completion: 2016-01-28
• Study Completion: 2016-01-28
• Results First Submitted: 2017-01-13
• Results First Submitted QC: 2017-01-13
• Results First Posted: 2017-03-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Dapagliflozin	Dapagliflozin	Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
Group 2: Dapagliflozin Placebo	Dapagliflozin Placebo	Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change in HbA1c From Baseline to Week 24	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

Name	Time	Method
Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24	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).
Adjusted Mean Change in Body Weight From Baseline to Week 24	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).
Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24	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).

Trial Locations

Locations (1)

Local Institution; 🇸🇬 Singapore, Singapore