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Diabetes Mellitus, Type 2Phase 2NCT02183324

BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus

A Phase 2 study testing Low dose of BI 1356 BS, Medium dose of BI 1356 BS and High dose of BI 1356 BS 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 evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg) administered orally once daily for 28 days in Japanese patients with type 2 diabetes mellitus. 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?
Low dose of BI 1356 BS, Medium dose of BI 1356 BS and High dose of BI 1356 BS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
No sites listed yet
Study dates
Feb 2007to Jun 2007
Phase
Phase 2
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

  • Japanese patients with a diagnosis of type 2 diabetes mellitus treated with diet and/or exercise only or with one or two oral hypoglycaemic agents except glitazones
  • Glycosylated haemoglobin A1 (HbA1c)
  • <= 8.5% at screening for patients treated with diet and/or exercise and/or one oral hypoglycaemic agent or
  • <= 8.0% at screening for patients treated with two oral hypoglycaemic agents
  • Age ≥21 and ≤ 70 years
  • BMI ≥ 17.6 and ≤ 35 kg/m2

Who cannot join

  • Any finding of the medical examination including blood pressure, pulse rate and electrocardiogram (ECG) deviating from normal and of not acceptable clinical relevance
  • Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency (NYHA II-IV), known cardiovascular diseases including hypertension (>150/95 mmHg), stroke, and transient ischemic attack (TIA).
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, except for type 2 diabetes mellitus, hyperlipidaemia and medically treated hypertension
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or relevant neurological disorders except 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 18Show 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 before drug administration except anti-hypertensives, acetylsalicylic acid, and statins
  • Use of drugs decreasing blood glucose within 10 days before drug administration
  • Participation in another trial with an investigational drug within two months before drug administration
  • Alcohol abuse
  • Drug abuse
  • Blood donation (100 mL or more within four weeks before drug administration)
  • Excessive physical activities (within one week before drug 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 such as aspartate aminotransferase (AST(serum glutamate oxaloacetate transaminase/ SGOT)), alanine transaminase (ALT(serum glutamate pyruvate transaminase/ SGPT)), alkaline phosphatase (γALP), and lactate dehydrogenase (LDH)
  • Fasted blood glucose >240 mg/dL (=13.3 mmol/L) on two consecutive days during washout
  • Serum creatinine above 1.3 mg/dL at screening
  • Pregnancy or child-bearing potential patients and breast-feeding 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

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Multiple Dose Phase II Study of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg in Tablet q.d. Administered Orally for 28 Days) to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Japanese Patients With Type 2 Diabetes Mellitus

Study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS (0.5 mg, 2.5 mg, and 10 mg) administered orally once daily for 28 days in Japanese patients with type 2 diabetes mellitus.

Being tested
Low dose of BI 1356 BS, Medium dose of BI 1356 BS, High dose of BI 1356 BS, 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.

  • Low dose of BI 1356 BSDrug

  • Medium dose of BI 1356 BSDrug

  • High dose of BI 1356 BSDrug

  • PlaceboDrug

Study groups in NCT02183324
Study groupRoleWhat they receive
Low dose of BI 1356 BSExperimentalNot described
Receives: Drug: Low dose of BI 1356 BS
Medium dose of BI 1356 BSExperimentalNot described
Receives: Drug: Medium dose of BI 1356 BS
High dose of BI 1356 BSExperimentalNot described
Receives: Drug: High dose of BI 1356 BS
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Global assessment of tolerability by the investigator on a 4-point scale (good, satisfactory, not satisfactory and bad)

    Measured: Day 43

  2. Number of patients with adverse events

    Measured: Up to day 50

  3. Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate)

    Measured: Up to day 50

  4. Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, and urinalysis)

    Measured: Up to day 50

Secondary outcomes (19)

  1. Maximum measured concentration of the analyte in plasma (Cmax) at different time points

    Measured: Up to day 43

  2. Time from last dosing to the maximum concentration of the analyte in plasma (tmax) at different time points

    Measured: Up to day 43

  3. Area under the concentration time curve of the analyte in plasma (AUC) at different time points

    Measured: Up to day 43

  4. Amount of the analyte that is eliminated in urine (Ae) at different time points

    Measured: Up to day 43

  5. Fraction of parent drug eliminated in urine (fe) at different time points

    Measured: Up to day 43

  6. Renal clearance of the analyte (CLR) at different time points

    Measured: Up to day 43

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

    Measured: After the last dose on day 28 up to day 43

  8. Average concentration of the analyte in plasma at steady state (Cavg)

    Measured: After the last dose on day 28 up to day 43

  9. Terminal half-life of the analyte in plasma at steady state (t1/2,ss)

    Measured: After the last dose on day 28 up to day 43

  10. Terminal rate constant in plasma at steady state (λz,ss)

    Measured: After last dose on day 28 up to day 43

  11. Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)

    Measured: After last dose on day 28 up to day 43

  12. Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)

    Measured: After last dose on day 28 up to day 43

  13. Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)

    Measured: After last dose on day 28 up to day 43

  14. Predose concentration of the analyte in plasma (Cpre) at different time points immediately before administration of the Nth dose

    Measured: Up to day 28

  15. Calculation of accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)

    Measured: Up to day 43

  16. Calculation of accumulation ratio of the analyte in plasma based on AUCτ (RA,AUCτ)

    Measured: Up to day 43

  17. Minimum dipeptidyl peptidase IV (DPP-IV) activity (Emin) at different time points

    Measured: Up to day 43

  18. Time to reach minimum DPP-IV activity (tmin) at different time points

    Measured: Up to day 43

  19. DPP-IV activity at different time points

    Measured: Up to day 43

Timeline

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

  1. First posted8 Jul 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02183324
Sponsor's protocol ID
1218.12
Status last verified
Dec 2017
First submitted
4 Jul 2014
Last updated
28 Dec 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose of BI 1356 BS, Medium dose of BI 1356 BS and High dose of BI 1356 BS 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 6 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 28 Dec 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Global assessment of tolerability by the investigator on a 4-point scale (good, satisfactory, not satisfactory and bad) (time frame: Day 43). The study lists 4 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 NCT02183324.

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 28 Dec 2017.

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