4 weeks treatment of type ii diabetic patients with bi 44847

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of the current study is to investigate the safety and tolerability of bi 44847 in male and female patients with type 2 diabetes following oral administration of repeated doses of 100 mg b.i.d, 400 mg b.i.d. and 800 mg b.i.d. over 28 days. a secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of bi 44847 after multiple dosing, including assessment of steady state.


Eligibility criteria:
inclusion criteria: * male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only or with one or 2 oral hypoglycaemic agent other than glitazones. in case of 2 oral hypoglycaemic agents, at least one of these may be taken at no more than 50% of its maximum dose; * age = \> 21 and age = \<70 years (female hysterectomised and male patients); * age = \>55 and age = \<70 years (female postmenopausal patients); * bmi = \>18.5 and bmi = \<40 kg/m2 (body mass index); * signed and dated written informed consent prior to admission to the study in accordance with gcp and the local legislation. exclusion criteria: * treatment with insulin, glitazones, or more than one oral hypoglycaemic agent (except if 2 agents and at least one of them not taken at more than 50% of maximum dose); * fasted blood glucose \> 240 mg/dl on two consecutive days during wash-out; hba1c \> 8.5 % at screening; * clinically relevant concomitant diseases other than type 2 diabetes, hyperlipidaemia and medically treated hypertension; * history of relevant allergy/hypersensitivity; * marked baseline prolongation of qt/qtc interval; * history of additional risk factors for tdp; * any laboratory value outside the reference range and the clinical relevance is not acceptable in the opinion of the investigator, or the value is more than 3 times higher than the upper limit of the reference range; * concomitant medication except for acetylsalicylic acid, statins, antihypertensives (diuretics not allowed), beta-blockers for bph and occasional use of paracetamol (doses of no more than 1000 mg; no more than 2000 mg per day; no more than 2 days per week); * change of drug dosing of allowed co-medication \< the last 6 weeks; intake of any medication \< 5 half-lives of the respective drug prior to first administration of study medication or during the trial, except allowed co-medication; * use of drugs which might reasonably influence the results of the trial or that prolong the qt/qtc interval (based on the knowledge at the time of patient inclusion) \< 10 days prior to first administration of study medication or during the trial; * use of grapefruit (or its juice) \< 10 days prior to first administration of study medication or during the trial; * participation in another trial with an investigational drug \< two months prior to first administration of study medication or during the trial; smoker; * inability to refrain from smoking on specified trial days; alcohol abuse; * drug abuse; * blood donation; * excessive physical activity; * male patients not using adequate contraception; * women of childbearing potential, positive pregnancy test or lactating