BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Low dose of BI 1356 BS
Medium dose of BI 1356 BS
High dose of BI 1356 BS
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Low dose of BI 1356 BS
Medium dose of BI 1356 BS
High dose of BI 1356 BS
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Global assessment of tolerability by the investigator on a 4-point scale (good, satisfactory, not satisfactory and bad)
Number of patients with adverse events
Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate)
Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, and urinalysis)
Secondary Outcome Measures
Maximum measured concentration of the analyte in plasma (Cmax) at different time points
Time from last dosing to the maximum concentration of the analyte in plasma (tmax) at different time points
Area under the concentration time curve of the analyte in plasma (AUC) at different time points
Amount of the analyte that is eliminated in urine (Ae) at different time points
Fraction of parent drug eliminated in urine (fe) at different time points
Renal clearance of the analyte (CLR) at different time points
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Average concentration of the analyte in plasma at steady state (Cavg)
Terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Terminal rate constant in plasma at steady state (λz,ss)
Mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss)
Apparent clearance of the analyte in plasma at steady state after extravascular multiple dose administration (CL/F,ss)
Apparent volume of distribution during the terminal phase λz at steady state following extravascular administration (Vz/F,ss)
Predose concentration of the analyte in plasma (Cpre) at different time points immediately before administration of the Nth dose
Calculation of accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)
Calculation of accumulation ratio of the analyte in plasma based on AUCτ (RA,AUCτ)
Minimum dipeptidyl peptidase IV (DPP-IV) activity (Emin) at different time points
Time to reach minimum DPP-IV activity (tmin) at different time points
DPP-IV activity at different time points
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02183324
Brief Title
BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus
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 Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose of BI 1356 BS
Arm Type
Experimental
Arm Title
Medium dose of BI 1356 BS
Arm Type
Experimental
Arm Title
High dose of BI 1356 BS
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Low dose of BI 1356 BS
Intervention Type
Drug
Intervention Name(s)
Medium dose of BI 1356 BS
Intervention Type
Drug
Intervention Name(s)
High dose of BI 1356 BS
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Global assessment of tolerability by the investigator on a 4-point scale (good, satisfactory, not satisfactory and bad)
Time Frame
Day 43
Title
Number of patients with adverse events
Time Frame
Up to day 50
Title
Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time Frame
Up to day 50
Title
Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, and urinalysis)
Time Frame
Up to day 50
Secondary Outcome Measure Information:
Title
Maximum measured concentration of the analyte in plasma (Cmax) at different time points
Time Frame
Up to day 43
Title
Time from last dosing to the maximum concentration of the analyte in plasma (tmax) at different time points
Time Frame
Up to day 43
Title
Area under the concentration time curve of the analyte in plasma (AUC) at different time points
Time Frame
Up to day 43
Title
Amount of the analyte that is eliminated in urine (Ae) at different time points
Time Frame
Up to day 43
Title
Fraction of parent drug eliminated in urine (fe) at different time points
Time Frame
Up to day 43
Title
Renal clearance of the analyte (CLR) at different time points
Time Frame
Up to day 43
Title
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
Title
Average concentration of the analyte in plasma at steady state (Cavg)
Time Frame
After the last dose on day 28 up to day 43
Title
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
Title
Terminal rate constant in plasma at steady state (λz,ss)
Time Frame
After last dose on day 28 up to day 43
Title
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
Title
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
Title
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
Title
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
Title
Calculation of accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax)
Time Frame
Up to day 43
Title
Calculation of accumulation ratio of the analyte in plasma based on AUCτ (RA,AUCτ)
Time Frame
Up to day 43
Title
Minimum dipeptidyl peptidase IV (DPP-IV) activity (Emin) at different time points
Time Frame
Up to day 43
Title
Time to reach minimum DPP-IV activity (tmin) at different time points
Time Frame
Up to day 43
Title
DPP-IV activity at different time points
Time Frame
Up to day 43
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1218/1218.12_U08-3213-01.pdf
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/24393553
Description
Related Info
Learn more about this trial
BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus
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