A phase III randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of BI 1356 2.5 mg + metformin 500 mg, or of BI 1356 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg twice daily), and BI 1356 (5.0 mg, once daily) over 24 weeks in drug naïve or previously treated (4 weeks wash-out and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control

Conditions: Patients with type 2 diabetes • with insufficient glycaemic control (HbA1c = 7.5 to < 11 % at Visit 2)• with very poor glycaemic control (HbA1c = 11 %)
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

Registration Number: EUCTR2008-001640-40-LT

Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1700

Inclusion Criteria

• Male and female patients with a diagnosis of type 2 diabetes mellitus, either
treatment drug naïve patients or previously treated patients with not more than
one oral antidiabetic drug. Antidiabetic therapy has to be unchanged for 10 weeks
prior to informed consent
• Diagnosis of type 2 diabetes prior to informed consent
• Glycosylated haemoglobin A1c (HbA1c) at Visit 1a (Screening):
For patients undergoing wash-out (pre-treated patients): HbA1c = 7.0 to = 10.5 %.
For naïve patients not undergoing wash-out: HbA1c = 7.5 to < 11.0%
• Glycosylated haemoglobin A1c (HbA1c) = 7.5 to < 11.0% at Visit 2 (Start of Run-in)
• Patients with very poor glycaemic control [HbA1c = 11 %, determined by
examination at Visit 1a (naïve patients) or at Visit 2 (naïve and pre-treated
patients)] will be eligible to participate in an additional open-label study arm
• Age = 18 and = 80 years at Visit 1a (Screening)
• BMI (Body Mass Index) = 40 kg/m2 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 (AP) above 3 x upper limit of normal (ULN) as
determined at Visit 1a
• Known hypersensitivity or allergy to verum or its excipients or metformin or placebo
• Treatment with rosiglitazone or pioglitazone within 3 months prior to informed
consent
• Treatment with a GLP-1 analogue (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
• Current treatment with systemic steroids at time of informed consent or change in
dosage of thyroid hormones within 6 weeks prior to informed consent
• Renal failure or renal impairment at Visit 1a (screening) with an eGFR < 60 ml/min
• Gastric bypass
• Dehydration by clinical judgement of the investigator
• Unstable or acute congestive heart failure
• Acute or chronic metabolic acidosis (present in patient history)
• Hereditary galactose intolerance