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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI 10773; Drug: Metformin; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881530

2008-007938-21 (EudraCT Number)

1245.24

Details and patient eligibility

About

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.

Enrollment: 660 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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660 participants in 4 patient groups

Sitagliptin

Active Comparator group

Description:

100 mg

Treatment:

Drug: Sitagliptin

Metformin

Active Comparator group

Description:

2000 mg

Treatment:

Drug: Metformin

BI 10773 X mg

Experimental group

Description:

lower dose

Treatment:

Drug: BI 10773

Drug: BI 10773

BI 10773 Y mg

Experimental group

Description:

higher dose

Treatment:

Drug: BI 10773

Drug: BI 10773