4 Weeks Treatment of Type II Diabetic Patients With BI 44847

NCT ID: NCT00558909

Last Updated: 2014-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Primary Study Purpose: TREATMENT

Interventions

BI 44847

Intervention Type: DRUG

placebo for BI 44847

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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

Countries

Germany; Netherlands

Other Identifiers

1224.4

Identifier Type: -

Identifier Source: org_study_id