BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus

December 27, 2017 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Low dose of BI 1356 BS
Drug: Low dose of BI 1356 BS
Experimental: Medium dose of BI 1356 BS
Drug: Medium dose of BI 1356 BS
Experimental: High dose of BI 1356 BS
Drug: High dose of BI 1356 BS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Global assessment of tolerability by the investigator on a 4-point scale (good, satisfactory, not satisfactory and bad)
Time Frame: Day 43
Day 43
Number of patients with adverse events
Time Frame: Up to day 50
Up to day 50
Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time Frame: Up to day 50
Up to day 50
Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, and urinalysis)
Time Frame: Up to day 50
Up to day 50

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Maximum measured concentration of the analyte in plasma (Cmax) at different time points
Time Frame: Up to day 43
Up to day 43
Time from last dosing to the maximum concentration of the analyte in plasma (tmax) at different time points
Time Frame: Up to day 43
Up to day 43
Area under the concentration time curve of the analyte in plasma (AUC) at different time points
Time Frame: Up to day 43
Up to day 43
Amount of the analyte that is eliminated in urine (Ae) at different time points
Time Frame: Up to day 43
Up to day 43
Fraction of parent drug eliminated in urine (fe) at different time points
Time Frame: Up to day 43
Up to day 43
Renal clearance of the analyte (CLR) at different time points
Time Frame: Up to day 43
Up to day 43
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time Frame: After the last dose on day 28 up to day 43
After the last dose on day 28 up to day 43
Average concentration of the analyte in plasma at steady state (Cavg)
Time Frame: After the last dose on day 28 up to day 43
After the last dose on day 28 up to day 43
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time Frame: After the last dose on day 28 up to day 43
After the last dose on day 28 up to day 43
Terminal rate constant in plasma at steady state (λz,ss)
Time Frame: After last dose on day 28 up to day 43
After last dose on day 28 up to day 43
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
Time Frame: After last dose on day 28 up to day 43
After last dose on day 28 up to day 43
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Time Frame: After last dose on day 28 up to day 43
After last dose on day 28 up to day 43
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Time Frame: After last dose on day 28 up to day 43
After last dose on day 28 up to day 43
Predose concentration of the analyte in plasma (Cpre) at different time points immediately before administration of the Nth dose
Time Frame: Up to day 28
Up to day 28
Calculation of accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)
Time Frame: Up to day 43
Up to day 43
Calculation of accumulation ratio of the analyte in plasma based on AUCτ (RA,AUCτ)
Time Frame: Up to day 43
Up to day 43
Minimum dipeptidyl peptidase IV (DPP-IV) activity (Emin) at different time points
Time Frame: Up to day 43
Up to day 43
Time to reach minimum DPP-IV activity (tmin) at different time points
Time Frame: Up to day 43
Up to day 43
DPP-IV activity at different time points
Time Frame: Up to day 43
Up to day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1218.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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