NCT00558909

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 diabetes-mellitus-type-2

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

5 months

First QC Date

August 30, 2007

Last Update Submit

April 30, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

  • Weight and waist circumference - change from baseline

    Day 28 (Hour = 647:30)

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

    4 weeks

  • Frequency of patients with possible clinically significant abnormalities

    4 weeks

  • Micturition total frequency - change from baseline

    Day 28

  • Global tolerability - number of patients by category

    4 weeks

Secondary Outcomes (35)

  • Cmax (maximum concentration of the analyte in plasma)

    Day 1

  • Tmax (time from dosing to maximum concentration)

    Day 1

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

    Day 1

  • λz (terminal rate constant in plasma)

    Day 1

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

    Day 1

  • +30 more secondary outcomes

Interventions

BI 44847DRUG
placebo for BI 44847DRUG

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

1224.4.49002 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1224.4.49003 Boehringer Ingelheim Investigational Site

Mainz, Germany

Location

1224.4.49001 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

1224.4.31001 Boehringer Ingelheim Investigational Site

Zuidlaren, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2007

First Posted

November 15, 2007

Study Start

June 1, 2007

Primary Completion

November 1, 2007

Last Updated

May 1, 2014

Record last verified: 2014-04

Locations

NL(1)DE(3)