Status and phase
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Study type
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About
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 10773 with repeat dosing for eight days and the exploration of the pharmacokinetics and pharmacodynamics of BI 10773 after multiple dosing, including dose proportionality and assessment of steady state.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of its maximum dose)
Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) on two consecutive days during washout.
Glycosylated haemoglobin A1 (HbA1c) >8.5% at screening
Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
A history of additional risk factors for TdP (torsade des pointes) (e.g., heart failure, hypokalemia, family history of sudden death before the age of 50)
Primary purpose
Allocation
Interventional model
Masking
48 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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