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Diabetes Mellitus, Type 2Phase 1NCT02212925

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes

A Phase 1 study testing BI 14332 CL in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332 CL following administration of multiple rising oral doses over 10 days in patients with type 2 diabetes. 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 14332 CL
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
No sites listed yet
Study dates
Nov 2006to Mar 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 oral hypoglycaemic agent besides glitazones and who are not taking the maximum approved dose
  • Glycosylated haemoglobin A1 (HbA1c) ≥ 6.5% and ≤ 8.5 % at screening for patients treated with diet and exercise and/or one oral hypoglycaemic agent
  • Age ≥21 and Age ≤70 years (female hysterectomised and male patients) Age ≥60 and Age ≤70 years (female postmenopausal patients)
  • Body Mass Index (BMI) ≥18.5 and BMI ≤35 kg/m2

Who cannot join

  • Any finding of the medical examination (including BP, pulse rate (PR) and 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, myocardial infarction, other known cardiovascular diseases including hypertension > 140/90 mmHg, stroke and transient ischemic attack
  • 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. HIV, Hepatitis)
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
Show all 28Show 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
  • Antidiabetic treatment with more than one oral hypoglycaemic agent or insulin or glitazones and anti-hypertensive treatment with verapamil or diltiazem
  • 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 40 g/day = 5 units/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)
  • 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 protocol preparation within 10 days prior to administration or during the trial
  • Any laboratory value outside the reference range and the clinical relevance is not acceptable (or the value is more than three times higher than the upper limit of the normal range e.g. liver enzymes)
  • Change of drug dosing of allowed co-medication (anti-hypertensive agents, acetylic salicylic acid and statins) within the last 3 months
  • 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
  • Male patients not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • For female patients:
  • Child bearing potential
  • Positive pregnancy test
  • Lactation period

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses (0.5, 2.5, 10 and 20 mg q.d. for 10 Days) of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes (Randomised, Double-blind, Placebo-controlled Within the Dose Groups), Followed by a 4-week Treatment Part* (Randomised, Double-blind, Placebo-controlled) of Two Doses (Planned 5 and 20 mg) Selected on the Basis of Tolerability and DPP-4 Inhibition in the Multiple Rising Dose Part

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332 CL following administration of multiple rising oral doses over 10 days in patients with type 2 diabetes.

Being tested
BI 14332 CL, 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 14332 CLDrug

  • PlaceboDrug

Study groups in NCT02212925
Study groupRoleWhat they receive
BI 14332 CLExperimentalNot described
Receives: Drug: BI 14332 CL
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events

    Measured: up to 14 days after last drug administration

  2. Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate)

    Measured: up to 14 days after last drug administration

  3. Number of patients with clinically significant findings in ECG

    Measured: up to 14 days after last drug administration

  4. Number of patients with clinically significant findings in laboratory tests

    Measured: up to 14 days after last drug administration

  5. Assessment of tolerability by investigator on a 4-point scale

    Measured: up to 14 days after last drug administration

Secondary outcomes (14)

  1. Cmax (maximum concentration of the analyte in plasma)

    Measured: up to 18 days after first drug administration

  2. tmax (time from dosing to maximum concentration)

    Measured: up to 18 days after first drug administration

  3. 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: up to 18 days after first drug administration

  4. AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose)

    Measured: up to 18 days after first drug administration

  5. Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 h to 24 h)

    Measured: up to 11 days after first drug administration

  6. fe0-24 (fraction of analyte excreted in urine from time point 0 h to 24 h)

    Measured: up to 11 days after first drug administration

  7. CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 h until the time point 24 h)

    Measured: up to 11 days after first drug administration

  8. Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)

    Measured: up to 18 days after first drug administration

  9. Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)

    Measured: up to 18 days after first drug administration

  10. PTF (peak trough fluctuation)

    in percent

    Measured: up to 18 days after first drug administration

  11. RA,Cmax (accumulation ratio based on Cmax)

    Measured: up to 18 days after first drug administration

  12. RA,AUC(accumulation ratio based on AUCτ)

    Measured: up to 18 days after first drug administration

  13. Change in dipeptidyl-peptidase 4 (DPP-IV) activity

    Measured: baseline, up to 18 days after first drug administration

  14. Area under the curve of plasma glucose

    Measured: baseline, up to 3 hours after intake of standardized meal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2014 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2007

Resources

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
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02212925
Sponsor's protocol ID
1233.2
Status last verified
Aug 2014
First submitted
7 Aug 2014
Last updated
8 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 14332 CL 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 4 inclusion and 28 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: stopped early, as of the sponsor's last update on 8 Aug 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 was stopped early. Results are not available in the source record.

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 14 days after last drug administration). 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?

On the ClinicalTrials.gov record for NCT02212925.

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 Aug 2014.

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