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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: BI 10773; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167881

1245.28

2009-016244-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,549 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,549 participants in 2 patient groups

BI 10773 dose plus metformin

Experimental group

Description:

Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily

Treatment:

Drug: BI 10773

Drug: Placebo

Drug: Placebo

Glimepiride 1-4 mg plus metformin

Active Comparator group

Description:

Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Glimepiride