4 Weeks Treatment of Type II Diabetic Patients With BI 44847

Boehringer Ingelheim80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

BI 44847DRUG

placebo for BI 44847DRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (4)

1224.4.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

1224.4.49003 Boehringer Ingelheim Investigational Site

Mainz, Germany

1224.4.49001 Boehringer Ingelheim Investigational Site

Neuss, Germany

1224.4.31001 Boehringer Ingelheim Investigational Site

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

Weight and waist circumference - change from baseline

Time frame: Day 28 (Hour = 647:30)

Frequency of patients with maximal increase from baseline QTcF and QTcB interval

Time frame: 4 weeks

Frequency of patients with possible clinically significant abnormalities

Time frame: 4 weeks

Micturition total frequency - change from baseline

Time frame: Day 28

Global tolerability - number of patients by category

Time frame: 4 weeks

Secondary Outcomes

Cmax (maximum concentration of the analyte in plasma)

Time frame: Day 1

Tmax (time from dosing to maximum concentration)

Time frame: Day 1

t1/2 (terminal half-life of the analyte in plasma)

Time frame: Day 1

λz (terminal rate constant in plasma)

Time frame: Day 1

C12,1 (concentration of analyte in plasma at 12 hours post-drug administration after administration of the first dose)

Time frame: Day 1

AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval)

Data from ClinicalTrials.gov

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