- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183324
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- 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
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 |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Low dose of BI 1356 BS
|
|
Experimental: Medium dose of BI 1356 BS
|
|
Experimental: High dose of BI 1356 BS
|
What is the study measuring?
Primary Outcome Measures
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
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
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
February 1, 2007
Primary Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Actual)
December 28, 2017
Last Update Submitted That Met QC Criteria
December 27, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Linagliptin
Other Study ID 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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