4 Weeks Treatment of Type II Diabetic Patients With BI 44847

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558909
First received: August 30, 2007
Last updated: January 27, 2009
Last verified: January 2009

August 30, 2007
January 27, 2009
June 2007
November 2007   (final data collection date for primary outcome measure)
Not Provided
Physical examination; Vital signs (blood pressure, pulse rate); 12 lead ECG; Clinical laboratory tests; Micturition diary; Adverse events; Assessment of tolerability by investigator
Complete list of historical versions of study NCT00558909 on ClinicalTrials.gov Archive Site
Not Provided
phramacokinetics; pharmacodynamics: urinary glucose excretion; weighted mean daily glucose; oral glucose tolerance test; HbA1c, fructosamine and fasting insulin
Not Provided
Not Provided
 
4 Weeks Treatment of Type II Diabetic Patients With BI 44847
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.

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.

Not Provided
Interventional
Phase 1
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: BI 44847
  • Drug: placebo for BI 44847
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Not Provided
November 2007   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
 
NCT00558909
1224.4
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP