- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183350
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS in Patients With Type 2 Diabetes
July 4, 2014 updated by: Boehringer Ingelheim
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses (1, 2.5, 5, 10 and 25 mg q.d. for 12 Days) of BI 1356 BS as Powder in the Bottle (PIB) in Patients With Type 2 Diabetes (Randomised, Double-blind, Placebo-controlled Within the Dose Groups).
The primary objective of the current study was to investigate the safety and tolerability of BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and 10 mg over 12 days in male patients with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 1
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
19 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Male patients with proven diagnose of type 2 diabetes mellitus treated with diet and exercise only or with one (or two) 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 or
- ≤ 8.0 % at screening for patients treated with two oral hypoglycaemic agents
- Age ≥21 and Age ≤65 years
- BMI ≥18.5 and BMI ≤35 kg/m2 (Body Mass Index)
- Caucasian ethnicity
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice GCP and the local legislation
Exclusion Criteria:
- Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of not acceptable clinical relevance
- Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular diseases including hypertension > 160/110 mmHg, stroke and Transient ischaemic attack (TIA)
- 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. 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 prior to administration or during the trial except allowed co-medication
- Use of drugs 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
- 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 60 g/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)
- Any laboratory value outside the reference range that is of not acceptable clinical relevance
- Change of drug dosing of allowed co-medication (anti-hypertensive agents, acetylic salicylic acid and statins) within the last 3 months
- Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 120 ms or QTcB > 450 ms or QT >500 ms
- 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
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: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: BI 1356 BS - single rising dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: up to 28 days
|
up to 28 days
|
Number of patients with abnormal findings in physical examination
Time Frame: up to 28 days
|
up to 28 days
|
Number of patients with abnormal changes in Vital signs (blood pressure (BP), pulse rate (PR))
Time Frame: up to 28 days
|
up to 28 days
|
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram)
Time Frame: up to 28 days
|
up to 28 days
|
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 28 days
|
up to 28 days
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: up to 28 days
|
up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax (maximum concentration of the analyte in plasma)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
tmax (time from dosing to maximum concentration)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
AUC (area under the concentration-time curve of the analyte in plasma)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
Ae (amount of analyte that is eliminated in urine)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
fe (fraction of analyte excreted in urine)
Time Frame: up to 288 h
|
up to 288 h
|
CLR (renal clearance of the analyte in plasma)
Time Frame: up to 288 h
|
up to 288 h
|
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
λz,ss (terminal rate constant in plasma at steady state)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
MRTpo,ss (mean residence time of the analyte in the body after 12 administrations at steady state)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state)
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
Changes in PTF (peak trough fluctuation)
Time Frame: up to 28 days
|
up to 28 days
|
RA,Cmax based on Cmax
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
RA,AUC based on AUCτ
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
Changes in Dipeptidyl-Peptidase IV (DPP-IV) activity in plasma
Time Frame: predose, up to 456 h
|
predose, up to 456 h
|
Change in plasma glucose levels
Time Frame: up to 13 days
|
up to 13 days
|
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
April 1, 2005
Primary Completion (Actual)
August 1, 2005
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 (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
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
- 1218.2
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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