4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Male and postmenopausal or hysterectomised female patients with type 2 diabetes

• Age >18 and < 70 years

• BMI >18.5 and <40 kg/m2

Exclusion Criteria:

• Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;

• Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;

• HbA1c > 8.5 %