Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets

Launched by BOEHRINGER INGELHEIM · Aug 15, 2013

Keywords

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Eligibility criteria

• Inclusion criteria:
• • 1. Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or on a maximum of two oral antidiabetic agents except thiazolidindiones with at least one agent taken at 50% of its maximum dose or less.
• • 2. Glycosylated haemoglobin A1 (HbA1c) £ 8.5 % at screening.
• • 3. Age \>21 and Age \<70 years (male and hysterectomised female patients) Age \>60 and Age \<70 years (postmenopausal female patients)
• • 4. Body Mass Index (BMI) \>18.5 and \<40 kg/m2
• • 5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
• Exclusion criteria:
• • 1. 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)
• • 2. Fasted blood glucose \> 240 mg/dl (\>13.3 mmol/L) on two consecutive days during washout.
• • 3. Glycosylated haemoglobin A1 (HbA1c) \>8.5% at screening
• 4. Clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension, such as:
• • Any late stage complication of diabetes (e.g. retinopathy, polyneuropathy, vegetative disorders, diabetic foot)
• • Renal insufficiency (calculated creatinine clearance \< 80 ml/min/1.73m²)
• • Cardiac insufficiency NYHA II-IV, myocardial infarction, other known cardiovascular diseases including hypertension \> 160/95mmHg (measured at training visit and each of the timepoints of Day -1), stroke and TIA (Transistoric ischaemic attack)
• • Neurological disorders (such as epilepsy) or psychiatric disorders
• • Acute or relevant chronic infections (e.g. HIV, repeated urogenital infections)
• • Any gastrointestinal, hepatic, respiratory, endocrine or immunological disorder
• • 5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• • 6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
• • 7. 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)