Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
4 Weeks Treatment of Type II Diabetic Patients With BI 44847
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00558909
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 44847
Drug: placebo for BI 44847
Phase I

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 4 Weeks Treatment With Three Selected Oral Doses of BI 44847 as Tablet in Female and Male Patients With Type 2 Diabetes.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Physical examination; Vital signs (blood pressure, pulse rate); 12 lead ECG; Clinical laboratory tests; Micturition diary; Adverse events; Assessment of tolerability by investigator

Secondary Outcome Measures:
  • pharmacokinetics; pharmacodynamics: urinary glucose excretion; weighted mean daily glucose; oral glucose tolerance test; HbA1c, fructosamine and fasting insulin

Estimated Enrollment: 80
Estimated Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558909

Locations
Germany
Boehringer Ingelheim Investigational Site
Neuss, Germany, 41460
Boehringer Ingelheim Investigational Site
Berlin, Germany, 14050
Boehringer Ingelheim Investigational Site
Mainz, Germany, 55116
Netherlands
Boehringer Ingelheim Investigational Site
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim BV/Alkmaar
  More Information

Study ID Numbers: 1224.4, EudraCT No.: 2007-000373-35
Study First Received: August 30, 2007
Last Updated: June 11, 2008
ClinicalTrials.gov Identifier: NCT00558909  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009