Phase III Insulin Add-On Asia Regional Program - ST

• Status: Completed
• Trial end date: 2016-01-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca; Bristol-Myers Squibb
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin; Insulin; Insulin, Globin Zinc

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