Diabetes Mellitus, Type 2Phase 1NCT00558909
4 Weeks Treatment of Type II Diabetic Patients With BI 44847
A Phase 1 study testing BI 44847 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BI 44847
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2007to Nov 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
1224.4.49002 Boehringer Ingelheim Investigational Site
Berlin
1224.4.49003 Boehringer Ingelheim Investigational Site
Mainz
1224.4.49001 Boehringer Ingelheim Investigational Site
Neuss
Netherlands1 site
1224.4.31001 Boehringer Ingelheim Investigational Site
Zuidlaren
About this 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.
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
- Being tested
- BI 44847, placebo for BI 44847
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 44847Drug
placebo for BI 44847Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight and waist circumference - change from baseline
Measured: Day 28 (Hour = 647:30)
Frequency of patients with maximal increase from baseline QTcF and QTcB interval
Measured: 4 weeks
Frequency of patients with possible clinically significant abnormalities
Measured: 4 weeks
Micturition total frequency - change from baseline
Measured: Day 28
Global tolerability - number of patients by category
Measured: 4 weeks
Secondary outcomes (35)
Cmax (maximum concentration of the analyte in plasma)
Measured: Day 1
Tmax (time from dosing to maximum concentration)
Measured: Day 1
t1/2 (terminal half-life of the analyte in plasma)
Measured: Day 1
λz (terminal rate constant in plasma)
Measured: Day 1
C12,1 (concentration of analyte in plasma at 12 hours post-drug administration after administration of the first dose)
Measured: 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)
Measured: Day 1
AUC0-12 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h after administration of the first dose)
Measured: Day 1
Ae0-12 (amount of analyte that is eliminated in urine over the time interval 0 h to 12 h)
Measured: Day 1
fe0-12 (fraction of analyte excreted unchanged in urine from time points 0 h to 12 h)
Measured: Day 1
CLR (renal clearance of the analyte in plasma after extravascular administration - based on 0 - 12 hour data)
Measured: Day 1
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: Day 1
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: Day 1
Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)
Measured: Day 28
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Measured: Day 28
Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)
Measured: Day 28
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the last dose)
Measured: Day 28
C12,ss (concentration of analyte in plasma at 12 hours post-drug administration at steady state)
Measured: Day 28
tmax,ss (time from dosing to maximum concentration at steady state)
Measured: Day 28
tmin,ss (time from dosing to minimum concentration during a dosing interval)
Measured: Day 28
AUC0-tz,ss (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 last dosing interval)
Measured: Day 28
AUC0-12,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h at steady-state)
Measured: Day 28
MRTpo,ss (mean residence time of the analyte in the body after 56 administrations (b.i.d.) at steady state)
Measured: Day 28
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Measured: Day 28
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Measured: Day 28
Ae0-12,ss (amount of analyte that is eliminated in urine at steady state over the time interval 0 to 12 h)
Measured: Day 28
fe0-12,ss (fraction of analyte excreted unchanged in urine at steady state over the time interval 0 to 12 h)
Measured: Day 28
CLR,ss (renal clearance of the analyte at steady state - based on 0 - 12 hour data)
Measured: Day 28
RA,Cmax based on Cmax
Measured: following 55 doses (bid)
RA,AUC based on AUCτ
Measured: following 55 doses (bid)
Predose concentrations of the analyte in plasma
Measured: 5 minutes before drug administration on days 2,3,4,7,14,21,26,27,28 and 29
Change from baseline in UGE, AE0-24
Measured: Day 27
Change from baseline in weighted MDG, AUEC0-24
Measured: Day 27
Epre-corrected AUEC0-5 following OGTT
Measured: Day 28
Cavg (average concentration)
Measured: day 28
PTF (peak trough fluctuation).
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startJun 2007
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558909
- Sponsor's protocol ID
- 1224.4
- Status last verified
- Apr 2014
- First submitted
- 30 Aug 2007
- Last updated
- 1 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00558909
- Acronym / sponsor ID
- 1224.4
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Nov 2007 (actual)
- First posted
- 15 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 44847 | Drug | – |
| placebo for BI 44847 | Drug | – |
Primary outcome
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
35 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)
Time frame: Day 1
AUC0-12 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h after administration of the first dose)
Time frame: Day 1
Ae0-12 (amount of analyte that is eliminated in urine over the time interval 0 h to 12 h)
Time frame: Day 1
fe0-12 (fraction of analyte excreted unchanged in urine from time points 0 h to 12 h)
Time frame: Day 1
CLR (renal clearance of the analyte in plasma after extravascular administration - based on 0 - 12 hour data)
Time frame: Day 1
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Day 1
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Day 1
Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: Day 28
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: Day 28
Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)
Time frame: Day 28
Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the last dose)
Time frame: Day 28
C12,ss (concentration of analyte in plasma at 12 hours post-drug administration at steady state)
Time frame: Day 28
tmax,ss (time from dosing to maximum concentration at steady state)
Time frame: Day 28
tmin,ss (time from dosing to minimum concentration during a dosing interval)
Time frame: Day 28
AUC0-tz,ss (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 last dosing interval)
Time frame: Day 28
AUC0-12,ss (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 h at steady-state)
Time frame: Day 28
MRTpo,ss (mean residence time of the analyte in the body after 56 administrations (b.i.d.) at steady state)
Time frame: Day 28
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: Day 28
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Time frame: Day 28
Ae0-12,ss (amount of analyte that is eliminated in urine at steady state over the time interval 0 to 12 h)
Time frame: Day 28
fe0-12,ss (fraction of analyte excreted unchanged in urine at steady state over the time interval 0 to 12 h)
Time frame: Day 28
CLR,ss (renal clearance of the analyte at steady state - based on 0 - 12 hour data)
Time frame: Day 28
RA,Cmax based on Cmax
Time frame: following 55 doses (bid)
RA,AUC based on AUCτ
Time frame: following 55 doses (bid)
Predose concentrations of the analyte in plasma
Time frame: 5 minutes before drug administration on days 2,3,4,7,14,21,26,27,28 and 29
Change from baseline in UGE, AE0-24
Time frame: Day 27
Change from baseline in weighted MDG, AUEC0-24
Time frame: Day 27
Epre-corrected AUEC0-5 following OGTT
Time frame: Day 28
Cavg (average concentration)
Time frame: day 28
PTF (peak trough fluctuation).
Time frame: day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 44847 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight and waist circumference - change from baseline (time frame: Day 28 (Hour = 647:30)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.