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About
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
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Inclusion criteria
Exclusion criteria
Myocardial infarction, stroke or Transient Isquemic Atack (TIA) within 6 months prior to Inform Consent (IC)
Impaired hepatic function, defined by serum levels of either Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or alkaline phosphatase above 3 x upper limit of normal (ULN) determined at Visit 1a.
Known hypersensitivity or allergy to the investigational product or its excipients and/or to hydrochloride of pioglitazone or its excipients
Treatment with Glucagon-like peptide-1 (GLP-1) analogue / agonist within 3 months prior to IC.
Treatment with insulin within 3 months prior to IC
Treatment with anti-obesity drugs 3 months prior to IC.
Alcohol abuse within the 3 months prior to IC that would interfere with trial participation or drug abuse.
Participation in another trial with an investigational drug within 2 months prior to IC.
Fasting blood glucose > 240 mg/dl (=13.3 mmol/L) at screening (Visit 1).
Pre-menopausal women (last menstruation < or =1 year prior to signing IC) who:
Treatment with systemic steroids or change in the dosage of thyroid hormone within six weeks prior to IC
Heart failure New York Heart Asociation (NYHA) class I-IV, or history of heart failure.
Diabetic ketoacidosis within 6 months prior to IC.
Hemodialyzed patients due to limited experience with Thiazolidinediones (TZDs)
Any other clinical condition wich, in the opinion of the investigator, would not alow safe completion of the protocol and safe administration of BI1356 and pioglitazone.
Primary purpose
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Interventional model
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389 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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