Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Empagliflozin; Glimepiride; Metformin

Criteria

Inclusion criteria:

• Diagnosis typ 2 diabetes mellitus

• Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation

• HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1

• 18 years or more

• BMI equal or less than 45Kg/m2

Exclusion criteria:

• Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in

• Any other antidiabetic drug within 12 weeks prior to randomisation except metformin

• Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent

• Indication of liver disease

• Moderate to severe renal impairment

• Bariatric surgery within past 2 years

• Medical history of cancer or treatment for cancer within last 5 years

• Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell

• Contraindications hypersensitivity to concomitant drugs

• Treatment with anti-obesity drugs