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 type 2 diabetic patients with insufficient glycaemic control despite metformin therapy

• Conditions: Type 2 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-002457-24-FI
• Lead Sponsor: Boehringer Ingelheim Finland Ky

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1.Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug (antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent and patients should receive standard diet and exercise counseling)
2.Diagnosis of type 2 diabetes prior to informed consent
3.Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):
For patients undergoing wash out of previous medication: HbA1c =6.5 to =9.0%
For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%
4.Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
5.Age =18 and = 80 years at Visit 1a (Screening)
6.BMI (Body Mass Index) = 40 kg/m2 at Visit 1a (Screening)
7.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

1.Myocardial infarction, stroke or TIA within 6 months prior to informed consent
2.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
3.Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
4.Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
5.Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
6.Treatment with insulin within 3 months prior to informed consent
7.Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
8.Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
9.Participation in another trial with an investigational drug within 2 months prior to informed consent
10.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.
11.Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
12.Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a)
13.Dehydration by clinical judgement of the investigator
14.Unstable or acute congestive heart failure
15.Acute or chronic metabolic acidosis (present in patient history)
16.Hereditary galactose intolerance

Study & Design

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