Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: matching placebo; Drug: Metformin; Drug: BI 1356; Drug: Bi 1356 + metformin; Drug: BI 1356 + metformin; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798161

2008-001640-40 (EudraCT Number)

1218.46

Details and patient eligibility

About

The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

Enrollment: 857 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm

Exclusion criteria

Myocardial infarction, stroke or transient ischemic attack (TIA), unstable or acute congestive heart failure, impaired hepatic function, treatment with rosiglitazone or pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with systemic steroids, renal failure or impairment, gastric bypass

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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857 participants in 6 patient groups, including a placebo group

BI 1356 + metformin

Experimental group

Description:

BI 1356 low dose + metformin 500 mg, twice daily

Treatment:

Drug: BI 1356 + metformin

matching placebo

Placebo Comparator group

Description:

matching placebo

Treatment:

Drug: matching placebo

BI 1356+ Metformin

Experimental group

Description:

BI 1356 low dose + metformin 1000 mg, twice daily

Treatment:

Drug: Bi 1356 + metformin

Metformin

Active Comparator group

Description:

Metformin 500 mg, twice daily

Treatment:

Drug: Metformin

metformin

Active Comparator group

Description:

Metformin 1000 mg, twice daily

Treatment:

Drug: metformin

BI 1356

Experimental group

Description:

BI 1356 high dose, once daily

Treatment:

Drug: BI 1356