Diabetes Mellitus, Type 2Phase 1NCT01282970
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 Diabetes
A Phase 1 study testing BI 135585 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Germany.
Trial summary
The objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BI 135585
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Jul 2011
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and postmenopausal or surgically sterilised female patients with an established diagnosis of type 2 diabetes mellitus prior to informed consent
- Antidiabetic treatment with diet and exercise alone or with not more than one oral hypoglycaemic drug except glitazones, glucagon-like peptide 1 (GLP-1) analogues or dipeptidyl-peptidase 4 (DPP-4) inhibitors.
- Antidiabetic treatment unchanged for 12 weeks prior to informed consent
- Glycosylated haemoglobin A1 (HbA1c) ≤ 8.5% at screening
- Age ≥ 20 and age ≤ 70 years
- BMI ≥ 25 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
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of not acceptable clinical relevance
- Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
- Gastrointestinal tract surgery that might affect absorption and elimination of drugs
- Diseases of the central nerve system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
- Chronic or relevant acute infections (e.g. HIV, hepatitis)
Show all 11Show fewer
- History of allergy/hypersensitivity (including allergy to drug or its excipients) that are deemed relevant to subject's safety or the trial by the investigator
- Intake of drugs with a long half-life (> 24 hours) within one month prior to administration of the trial drug except for allowed co-medication
- Treatment with glitazones, GLP-1 analogues, insulin, DPP-4 inhibitors, systemic or inhaled glucocorticoids, or anti-obesity drugs (e.g. orlistat) within 12 weeks prior to informed consent
- Sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin, verapamil, budesonide, buspirone, eplerenone , eletriptan, felodipine, fluticasone, midazolam, saquinavir, sildenafil, vardenafil) or CYP3A4 substrates with narrow therapeutic range (e.g. cyclosporine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, terfenadine) or drugs that prolong the QT/QTc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to first administration of the trial drug
- other exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses (5 to 100 mg q.d. for 14 Days) of BI 135585 XX in Patients With Type 2 Diabetes Mellitus (Randomized, Double-blind Placebo-controlled Within Dose Groups)
The objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BI 135585, Placebo to BI 135585
- 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 135585Drug
oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days
Placebo to BI 135585Drug
oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days
| Study group | Role | What they receive |
|---|---|---|
| BI 135585 | Experimental | once daily doses as oral solution or tablet formulation over 14 days Receives: Drug: BI 135585 |
| Placebo to BI 135585 | Placebo comparator | once daily doses as oral solution or tablet formulation over 14 days Receives: Drug: Placebo to BI 135585 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of BI 135585 will be assessed in a descriptive way using physical examinations (occurence of findings), vital signs, electrocardiograms, laboratory tests, and incidence and severity of adverse events.
Measured: up to 16 days post treatment
Secondary outcomes (26)
Assessment of Pharmacokinetic parameter Cmax (maximum measured concentration of the analyte in plasma) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter tmax (time from dosing to maximum measured concentration) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter λz (terminal rate constant in plasma) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter λz,ss (terminal rate constant in plasma at steady state) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter t1/2,ss (terminal half-life of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter MRTpo,ss (mean residence time of the analyte in the body after multiple oral administrations at steady state) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter PTF (Peak-Trough Fluctuation) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cavg (average concentration of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Aet1-t2,ss (amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter fet1-t2,ss (fraction of analyte eliminated in urine at steady state from time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter CLR,t1-t2,ss (renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state) of BI 135585 following single and multiple dose oral administration
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple dose oral administration over a uniform dosing interval τ, expresses ratio of Cmax at steady state and after single dose)
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple dose oral administration over a uniform dosing interval τ, expresses ratio of AUC at steady state and after single dose)
Measured: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cpre,N (the predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered)
Measured: up to 10 days post treatment
Exploratory evaluation of the pharmacodynamics of BI 135585 by determination of 11beta-hydroxysteroid dehydrogenase type 1 activity in adipose tissue (ex vivo)
Measured: up to 24 hours post treatment
Exploratory evaluation of the pharmacodynamics of BI 135585 by measuring of cortisol and cortisone and their metabolites in urine
Measured: up to 24 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282970
- Sponsor's protocol ID
- 1283.2
- Other IDs
- 2010-022698-32
- Status last verified
- Nov 2014
- First submitted
- 24 Jan 2011
- Last updated
- 19 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses (5 to 100 mg q.d. for 14 Days) of BI 135585 XX in Patients With Type 2 Diabetes Mellitus (Randomized, Double-blind Placebo-controlled Within Dose Groups)
- ClinicalTrials.gov ID
- NCT01282970
- Acronym / sponsor ID
- 1283.2
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- First posted
- 25 Jan 2011 (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 objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 135585 | Experimental | Drug: BI 135585once daily doses as oral solution or tablet formulation over 14 days |
| Placebo to BI 135585 | Placebo comparator | Drug: Placebo to BI 135585once daily doses as oral solution or tablet formulation over 14 days |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and postmenopausal or surgically sterilised female patients with an established diagnosis of type 2 diabetes mellitus prior to informed consent
- Antidiabetic treatment with diet and exercise alone or with not more than one oral hypoglycaemic drug except glitazones, glucagon-like peptide 1 (GLP-1) analogues or dipeptidyl-peptidase 4 (DPP-4) inhibitors.
- Antidiabetic treatment unchanged for 12 weeks prior to informed consent
- Glycosylated haemoglobin A1 (HbA1c) ≤ 8.5% at screening
- Age ≥ 20 and age ≤ 70 years
Key exclusion criteria (11 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of not acceptable clinical relevance
- Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
- Gastrointestinal tract surgery that might affect absorption and elimination of drugs
- Diseases of the central nerve system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
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 135585oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days | Drug | BI 135585 |
| Placebo to BI 135585oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days | Drug | Placebo to BI 135585 |
Primary outcome
Safety and tolerability of BI 135585 will be assessed in a descriptive way using physical examinations (occurence of findings), vital signs, electrocardiograms, laboratory tests, and incidence and severity of adverse events.
Time frame: up to 16 days post treatment
26 secondary outcomes
Assessment of Pharmacokinetic parameter Cmax (maximum measured concentration of the analyte in plasma) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter tmax (time from dosing to maximum measured concentration) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter λz (terminal rate constant in plasma) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter λz,ss (terminal rate constant in plasma at steady state) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter t1/2,ss (terminal half-life of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter MRTpo,ss (mean residence time of the analyte in the body after multiple oral administrations at steady state) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter PTF (Peak-Trough Fluctuation) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cavg (average concentration of the analyte in plasma at steady state) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Aet1-t2,ss (amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter fet1-t2,ss (fraction of analyte eliminated in urine at steady state from time point t1 to time point t2) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter CLR,t1-t2,ss (renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state) of BI 135585 following single and multiple dose oral administration
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple dose oral administration over a uniform dosing interval τ, expresses ratio of Cmax at steady state and after single dose)
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple dose oral administration over a uniform dosing interval τ, expresses ratio of AUC at steady state and after single dose)
Time frame: up to 10 days post treatment
Assessment of Pharmacokinetic parameter Cpre,N (the predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered)
Time frame: up to 10 days post treatment
Exploratory evaluation of the pharmacodynamics of BI 135585 by determination of 11beta-hydroxysteroid dehydrogenase type 1 activity in adipose tissue (ex vivo)
Time frame: up to 24 hours post treatment
Exploratory evaluation of the pharmacodynamics of BI 135585 by measuring of cortisol and cortisone and their metabolites in urine
Time frame: up to 24 hours post treatment
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 19 Nov 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 135585 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 1 site in Germany.
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 7 inclusion and 11 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 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability of BI 135585 will be assessed in a descriptive way using physical examinations (occurence of findings), vital signs, electrocardiograms, laboratory tests, and incidence and severity of adverse events. (time frame: up to 16 days post treatment). 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 19 Nov 2014.