Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: placebo; Drug: linagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621140

2007-002448-10 (EudraCT Number)

1218.16

Details and patient eligibility

About

To investigate efficacy, safety and tolerability of BI 1356 versus placebo

Enrollment: 503 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients with type 2 diabetes and insufficient glycaemic control.
• Age 18 or over and not older than 80 years

Exclusion criteria

• Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
• Myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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503 participants in 2 patient groups, including a placebo group

linagliptin 5 mg

Experimental group

Description:

linagliptin 5 mg once daily

Treatment:

Drug: linagliptin

placebo

Placebo Comparator group

Description:

placebo matching linagliptin 5 mg tablets

Treatment:

Drug: placebo