Diabetes Mellitus, Type 2Phase 1NCT02183350
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS in Patients With Type 2 Diabetes
A Phase 1 study testing BI 1356 BS - single rising dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim.
Trial summary
The primary objective of the current study was to investigate the safety and tolerability of BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and 10 mg over 12 days in male patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- BI 1356 BS - single rising dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Aug 2005
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients with proven diagnose of type 2 diabetes mellitus treated with diet and exercise only or with one (or two) oral hypoglycaemic agents besides glitazones
- Glycosylated haemoglobin A1 (HbA1c)
- ≤ 8.5 % at screening for patients treated with diet and exercise and/or one oral hypoglycaemic agent or
- ≤ 8.0 % at screening for patients treated with two oral hypoglycaemic agents
- Age ≥21 and Age ≤65 years
- BMI ≥18.5 and BMI ≤35 kg/m2 (Body Mass Index)
- Caucasian ethnicity
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice GCP and the local legislation
Who cannot join
- Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of not acceptable clinical relevance
- Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular diseases including hypertension > 160/110 mmHg, stroke and Transient ischaemic attack (TIA)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia and medically treated hypertension
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
- Chronic or relevant acute infections (e.g. Human immunodeficiency virus (HIV), Hepatitis)
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Show all 20Show fewer
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial except allowed co-medication
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of not acceptable clinical relevance
- Change of drug dosing of allowed co-medication (anti-hypertensive agents, acetylic salicylic acid and statins) within the last 3 months
- Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 120 ms or QTcB > 450 ms or QT >500 ms
- Fasted blood glucose > 240 mg/dl (=13.3 mmol/L) on two consecutive days during washout
- Serum creatinine above upper limit of normal at screening
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses (1, 2.5, 5, 10 and 25 mg q.d. for 12 Days) of BI 1356 BS as Powder in the Bottle (PIB) in Patients With Type 2 Diabetes (Randomised, Double-blind, Placebo-controlled Within the Dose Groups).
The primary objective of the current study was to investigate the safety and tolerability of BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and 10 mg over 12 days in male patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- BI 1356 BS - single rising dose, Placebo
- 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 1356 BS - single rising doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1356 BS - single rising dose | Experimental | Not described Receives: Drug: BI 1356 BS - single rising dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: up to 28 days
Number of patients with abnormal findings in physical examination
Measured: up to 28 days
Number of patients with abnormal changes in Vital signs (blood pressure (BP), pulse rate (PR))
Measured: up to 28 days
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram)
Measured: up to 28 days
Number of patients with abnormal changes in laboratory parameters
Measured: up to 28 days
Assessment of tolerability by investigator on a 4-point scale
Measured: up to 28 days
Secondary outcomes (18)
Cmax (maximum concentration of the analyte in plasma)
Measured: predose, up to 456 h
tmax (time from dosing to maximum concentration)
Measured: predose, up to 456 h
AUC (area under the concentration-time curve of the analyte in plasma)
Measured: predose, up to 456 h
Ae (amount of analyte that is eliminated in urine)
Measured: predose, up to 456 h
fe (fraction of analyte excreted in urine)
Measured: up to 288 h
CLR (renal clearance of the analyte in plasma)
Measured: up to 288 h
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Measured: predose, up to 456 h
Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)
Measured: predose, up to 456 h
λz,ss (terminal rate constant in plasma at steady state)
Measured: predose, up to 456 h
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: predose, up to 456 h
MRTpo,ss (mean residence time of the analyte in the body after 12 administrations at steady state)
Measured: predose, up to 456 h
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Measured: predose, up to 456 h
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Measured: predose, up to 456 h
Changes in PTF (peak trough fluctuation)
Measured: up to 28 days
RA,Cmax based on Cmax
Measured: predose, up to 456 h
RA,AUC based on AUCτ
Measured: predose, up to 456 h
Changes in Dipeptidyl-Peptidase IV (DPP-IV) activity in plasma
Measured: predose, up to 456 h
Change in plasma glucose levels
Measured: up to 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2005
- Primary completionAug 2005
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
- Single group
- Masking
- Double blind
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183350
- Sponsor's protocol ID
- 1218.2
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 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 (1, 2.5, 5, 10 and 25 mg q.d. for 12 Days) of BI 1356 BS as Powder in the Bottle (PIB) in Patients With Type 2 Diabetes (Randomised, Double-blind, Placebo-controlled Within the Dose Groups).
- ClinicalTrials.gov ID
- NCT02183350
- Acronym / sponsor ID
- 1218.2
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Aug 2005 (actual)
- First posted
- 8 Jul 2014 (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 was to investigate the safety and tolerability of BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and 10 mg over 12 days in male patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1356 BS - single rising dose | Experimental | Drug: BI 1356 BS - single rising dose |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male patients with proven diagnose of type 2 diabetes mellitus treated with diet and exercise only or with one (or two) oral hypoglycaemic agents besides glitazones
- Glycosylated haemoglobin A1 (HbA1c)
- Age ≥21 and Age ≤65 years
- BMI ≥18.5 and BMI ≤35 kg/m2 (Body Mass Index)
- Caucasian ethnicity
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of not acceptable clinical relevance
- Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular diseases including hypertension > 160/110 mmHg, stroke and Transient ischaemic attack (TIA)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia and medically treated hypertension
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
- Chronic or relevant acute infections (e.g. Human immunodeficiency virus (HIV), Hepatitis)
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 1356 BS - single rising dose | Drug | BI 1356 BS - single rising dose |
| Placebo | Drug | Placebo |
Primary outcome
Number of patients with adverse events
Time frame: up to 28 days
Number of patients with abnormal findings in physical examination
Time frame: up to 28 days
Number of patients with abnormal changes in Vital signs (blood pressure (BP), pulse rate (PR))
Time frame: up to 28 days
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram)
Time frame: up to 28 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 28 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: up to 28 days
18 secondary outcomes
Cmax (maximum concentration of the analyte in plasma)
Time frame: predose, up to 456 h
tmax (time from dosing to maximum concentration)
Time frame: predose, up to 456 h
AUC (area under the concentration-time curve of the analyte in plasma)
Time frame: predose, up to 456 h
Ae (amount of analyte that is eliminated in urine)
Time frame: predose, up to 456 h
fe (fraction of analyte excreted in urine)
Time frame: up to 288 h
CLR (renal clearance of the analyte in plasma)
Time frame: up to 288 h
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time frame: predose, up to 456 h
Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)
Time frame: predose, up to 456 h
λz,ss (terminal rate constant in plasma at steady state)
Time frame: predose, up to 456 h
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: predose, up to 456 h
MRTpo,ss (mean residence time of the analyte in the body after 12 administrations at steady state)
Time frame: predose, up to 456 h
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time frame: predose, up to 456 h
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Time frame: predose, up to 456 h
Changes in PTF (peak trough fluctuation)
Time frame: up to 28 days
RA,Cmax based on Cmax
Time frame: predose, up to 456 h
RA,AUC based on AUCτ
Time frame: predose, up to 456 h
Changes in Dipeptidyl-Peptidase IV (DPP-IV) activity in plasma
Time frame: predose, up to 456 h
Change in plasma glucose levels
Time frame: up to 13 days
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 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1356 BS - single rising dose in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim.
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 8 inclusion and 20 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with adverse events (time frame: up to 28 days). The study lists 6 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 8 Jul 2014.