A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Linagliptin; Drug: Linagliptin Placebo; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00740051

2007-007485-38 (EudraCT Number)

1218.50

Details and patient eligibility

About

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride)

Enrollment: 227 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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227 participants in 3 patient groups, including a placebo group

Linagliptin

Experimental group

Description:

52 week treatment

Treatment:

Drug: Linagliptin

Placebo

Placebo Comparator group

Description:

First 18 weeks of treatment

Treatment:

Drug: Linagliptin Placebo

Glimepiride

Active Comparator group

Description:

Placebo patients switch to glimepiride week19-52

Treatment:

Drug: Glimepiride