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A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg administered orally once daily) over 24 weeks, in drug naive or previously treated (6 weeks washout) type 2 diabetic patients with insufficient glycaemic control

A randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 1356 (5 mg administered orally once daily) over 24 weeks, in drug naive or previously treated (6 weeks washout) type 2 diabetic patients with insufficient glycaemic control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-002448-10-NL
Enrollment
450
Registered
2007-12-11
Start date
2008-01-26
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2 MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Product Name: BI 1356 Product Code: BI1356 Pharmaceutical Form: Film-coated tablet Current Sponsor code: BI 1356 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0

Sponsors

Boehringer ingelheim BV
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Signed and dated informed consent Type 2 diabetes mellitus, treated with a maximum of 1 antidiabetic drug. HbA1c >=6.5 and ==7%, ==65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Myocardial infarction, stoke or TIA wihtin 6 months prior to consent Impaired hepatic function Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to consent Treatment with more than 1 antidiabetic drug within 10 weeks prior to consent

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate efficacy, safety and tollerability of BI 1356 in patients with type 2 diabetes mellitus and insufficient glycaemic control;Secondary Objective: ;Primary end point(s): Change from baseline in HbA1c—

Countries

Italy, Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026