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. - ND

• Conditions: type 2 diabetic patients with insufficient glycaemic control; MedDRA version: 9.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitus

• Registration Number: EUCTR2007-002448-10-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

-Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment naive or treated with one antidiabetic medication. Antidiabetic therapy has to be unchanged for 10 weeks prior to the informed consent -Diagnosis of type 2 diabetes mellitus prior to informed consent -Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening) For patients undergoing washout of previous medication: HbA1c >=6.5 to <=9.0%. For patients not undergoing wash out of previous medication: HbA1c >=7.0 to <=10.0% -Glycosylated haemoglobin A1 (HbA1c) >=7.0 to <=10.0% at Visit 2 (Start of Runin) -Age >=18 and <80 years at Visit 1a (Screening) -BMI <=40 kg/m**2 (Body Mass Index) at Visit 1a (Screening) -Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Myocardial infarction, stroke or TIA within 6 months prior to informed consent -Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a -Known hypersensitivity or allergy to the investigational product or its excipients -Treatment with more than one antidiabetic drug within 10 weeks prior to informed consent -Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent -Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to informed consent -Treatment with insulin within 3 months prior to informed consent -Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent -Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse -Participation in another trial with an investigational drug within 2 months prior to informed consent -Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who: - are nursing or pregnant - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made -Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) versus placebo administered for 24 weeks as monotherapy in patients with type 2 diabetes mellitus and insufficient glycaemic control defined as HbA1c >=7% and <=10%.;Secondary Objective: Secondary objectives will be evaluated by the followings enpoints: The occurrence of a treat to target efficacy response, that is an HbA1c under treatment of <7.0% or <6.5% after 24 weeks of treatment Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment HBA1c reduction from baseline by Visit over time The change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment Meal Tolerance Test (MTT): change from baseline of two-hour postprandial glucose (2hPPG) after 24 weeks of treatment;Primary end point(s): the change from baseline in HbA1c (HbA1c after 24 weeks of treatment).