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Diabetes Mellitus, Type 2Phase 1NCT02211963

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 44847 in Female and Male Patients With Type 2 Diabetes

A Phase 1 study testing BI 44847 in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847 following administration of multiple rising oral doses over 8 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 44847
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
No sites listed yet
Study dates
Feb 2007to Jun 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 diagnose of type 2 diabetes mellitus treated with diet and exercise only or with one 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
  • Age ≥21 and Age ≤70 years (female hysterectomised and male patients) Age ≥60 and Age ≤70 years (female postmenopausal patients)
  • BMI ≥18.5 and BMI ≤35 kg/m2 (Body Mass Index)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice 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
  • Clinically relevant concomitant diseases like renal insufficiency (creatinine clearance < 80 ml/min/173m**2), cardiac insufficiency New York Heart Association II-IV, myocardial infarction, other known cardiovascular diseases including hypertension > 160/95mmHg, 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 and/or food 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
  • 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 de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • For female patients:
  • Child bearing potential without hysterectomy
  • Positive pregnancy test
  • Lactation period

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Oral Doses (50-800 mg b.i.d. or q.d. for 8 Days) of BI 44847 as Tablet in Female and Male Patients With Type 2 Diabetes

Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847 following administration of multiple rising oral doses over 8 days in patients with type 2 diabetes.

Being tested
BI 44847, 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 44847Drug

  • PlaceboDrug

Study groups in NCT02211963
Study groupRoleWhat they receive
BI 44847ExperimentalNot described
Receives: Drug: BI 44847
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 53 days

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

    Measured: up to 18 days

  3. Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG)

    Measured: up to 18 days

  4. Number of patients with clinically relevant laboratory findings

    Measured: up to 18 days

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

    Measured: Day 18

Secondary outcomes (21)

  1. Maximum concentration of the analyte in plasma for several time points (Cmax)

    Measured: up to 72 hours after drug administration

  2. Time from dosing to maximum concentration for several time points (tmax)

    Measured: up to 72 hours after drug administration

  3. Terminal half-life of the analyte in plasma for several time points (t1/2)

    Measured: up to 72 hours after drug administration

  4. Terminal rate constant in plasma for several time points (λz)

    Measured: up to 72 hours after drug administration

  5. Concentration of analyte in plasma for several time points

    Measured: 12 and 24 hours after drug administration on day 1 and 9

  6. Area under the concentration-time curve of the analyte in plasma for several time points (AUC)

    Measured: up to 72 hours after drug administration

  7. Amount of analyte that is eliminated in urine for several time points (Ae)

    Measured: up to 72 hours after drug administration

  8. Fraction of analyte excreted unchanged in urine for several time points (fe)

    Measured: up to 72 hours after drug administration

  9. Renal clearance of the analyte in plasma for several time points (CLR)

    Measured: up to 72 hours after drug administration

  10. Apparent clearance of the analyte in the plasma for several time points (CL/F)

    Measured: up to 72 hours after drug administration

  11. Apparent volume of distribution during the terminal phase λz following an extravascular dose for several time points (Vz/F)

    Measured: up to 72 hours after drug administration

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

    Measured: up to 72 hours after drug administration

  13. tmin,ss (time from dosing to minimum concentration during a dosing interval)

    Measured: up to 72 hours after drug administration

  14. Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose for several time points

    Measured: up to day 9

  15. MRTpo,ss (mean residence time of the analyte in the body after 11 administrations (b.i.d.) and 6 administrations (q.d.) respectively, at steady state)

    Measured: up to 72 hours after drug administration

  16. Cavg (average concentration)

    Measured: up to 72 hours after drug administration

  17. PTF (peak trough fluctuation)

    Measured: up to 72 hours after drug administration

  18. Accumulation ratio (RA) based on Cmax

    Measured: up to 72 hours after drug administration

  19. Accumulation ratio (RA) based on AUC

    Measured: up to 72 hours after drug administration

  20. Plasma glucose levels

    Measured: up to 15 hours after drug administration

  21. Amount of glucose excreted in urine

    Measured: up to 72 hours after drug administration

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 startFeb 2007
  3. Primary completionJun 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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02211963
Sponsor's protocol ID
1224.3
Status last verified
Aug 2014
First submitted
7 Aug 2014
Last updated
13 Aug 2014
Results posted
No

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.

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 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: finished, as of the sponsor's last update on 13 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 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 53 days). 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 NCT02211963.

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 13 Aug 2014.

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