Patients with type 2 diabetes. MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin monotherapy, or with metformin plus one other oral antidiabetic drug (the antidiabetic therapy must be stable (i.e. unchanged) for 12 weeks prior to randomisation Please note: Type 2 diabetes mellitus patients should be on a stable daily dose of preferably >= 1500 mg of metformin. Patients with less than 1500 mg Metformin per day will only be included if the investigator considers them on their maximum tolerated dose The metformin dose should not be increased or decreased during the trial 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 6.0 – 9.0% For patients not undergoing wash-out of previous medication: HbA1c 6.5 – 10% 4. Glycosylated haemoglobin A1 (HbA1c) 6.5 – 10.0% at Visit 2 (Start of Run-in) 5. Age >= 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 (Screening) 3. Known hypersensitivity or allergy to the investigational product or its excipients), metformin or Sulfonyureas (glimepiride) 4. Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent 5. Treatment with insulin or injectable GLP-1 analogue/agonists within 3 months prior to informed consent 6. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) 3 months prior to informed consent 7. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones (within 6 weeks prior to informed consent) 8. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation 9. Drug abuse 10. Participation in another trial with an investigational drug within 2 months prior to informed consent 11. Pre-menopausal women (last menstruation 1.5 mg/dl as determined at Visit 1a) 13. Hereditary galactose intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current trial is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg) compared to glimepiride given for 104 weeks as add-on therapy to metformin.;Secondary Objective: ;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c (HbA1c after 104 weeks). Throughout the study protocol the term "baseline" refers to the last observation prior to randomised period. | — |
Countries
Bulgaria, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Sweden, United Kingdom
Outcome results
None listed