Phase III Insulin Add-On Asia Regional Program - ST

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Diabetes

Treatments: Drug: Dapagliflozin Placebo; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02096705

MB102-137

Details and patient eligibility

About

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.

Enrollment: 477 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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477 participants in 2 patient groups, including a placebo group

Group 1: Dapagliflozin

Experimental group

Description:

Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin

Treatment:

Drug: Dapagliflozin

Group 2: Dapagliflozin Placebo

Placebo Comparator group

Description:

Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin

Treatment:

Drug: Dapagliflozin Placebo