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About
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.
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Inclusion criteria
Exclusion criteria
Myocardial infarction, stroke or TIA (transient ischaemic attack) within 6 months prior to the date of informed consent
Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT/SGPT), aspartase transaminase (AST/SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal (ULN), as determined at Visit 1a
Renal failure or renal impairment (serum creatinine >/= 1.5 mg/dl) as determined at Visit 1a
Treatment with rosiglitazone or pioglitazone within 3 months prior to the date of informed consent
Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to the date of informed consent
Treatment with insulin within 3 months prior to the date of informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, rimonabant, orlistat) within 3 months prior to the date of informed consent
Current treatment with systemic steroids (i.e. at the time of informed consent) or a change in the dosage of thyroid hormones within 6 weeks prior to the date of informed consent
Pre-menopausal women (last menstruation </= 1 year prior to the date of informed consent) who:
Known hypersensitivity or allergy to the investigational product or its excipients or to the trial background therapy (i.e. metformin in combination with a sulphonylurea) or sulphonamides
Dehydration (as confirmed by the Investigators clinical opinion)
Current acute or chronic metabolic acidosis
Primary purpose
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Interventional model
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1,058 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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