Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension

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

Summary

The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Empagliflozin; Metformin; Sitagliptin Phosphate

Criteria

Inclusion criteria:

• patients completing one of double blind phase II trials 1245.9 or 1245.10

• informed consent

Exclusion criteria:

• patients meeting withdrawal criteria of preceding trial

• significant hepatic impairment

• significant renal impairment with creatinine clearance < 50 ml/min

• contraindication to Metformin for all patients treated with Metformin

• premenopausal women that are nursing or pregnant or not practicing acceptable methods of birth control

• drug or alcohol abuse