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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS as Tablet in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02183415
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE July 4, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE August 2005
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2014)
  • Assessment of tolerability by investigator on a 4-point scale [ Time Frame: Day 50 ]
  • Incidence of adverse events [ Time Frame: up to 50 days ]
  • Number of patients with abnormal changes in clinical laboratory parameters [ Time Frame: Baseline, up to day 50 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2014)
  • Cmax (maximum concentration of the analyte in plasma) [ Time Frame: before and up to 43 days after first study drug administration ]
  • tmax (time from dosing to maximum concentration) [ Time Frame: before and up to 43 days after first study drug administration ]
  • AUC (area under the concentration-time curve of the analyte in plasma) for several time points [ Time Frame: before and up to 43 days after first study drug administration ]
  • Cmax,ss (maximum concentration of the analyte in plasma at steady state over a uniform dosing interval) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N) [ Time Frame: pre-dose on day 28 ]
  • tmax,ss (time from dosing to maximum concentration at steady state) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • AUCτ,ss (area under the concentration time curve of the analyte in plasma at steady state over a uniform dosing interval) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • λz,ss (terminal rate constant in plasma at steady state) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • t1/2,ss (terminal half-life of the analyte in plasma at steady state) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • MRTpo,ss (mean residence time of the analyte in the body after 12 administrations at steady state) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • Vz/F,ss (apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • PTF (peak trough fluctuation) [ Time Frame: before and 0:30 h, 1 h, 1:30 h, 2 h, 3 h, 4 h, 6 h, 8 h, and 12 hours after last study drug administration ]
  • Accumulation ratio (RA) based on Cmax [ Time Frame: up to 28 days ]
  • RA,AUC based on AUCτ [ Time Frame: up to 28 days ]
  • Dipeptidyl-Peptidase IV (DPP-IV) activity for several time points [ Time Frame: up to day 43 ]
  • Change in fasting plasma glucose (AUEC0-3) after MTT (meal tolerance test ) [ Time Frame: days -1, 1 and 29 ]
  • Plasma glucose levels [ Time Frame: up to day 43 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 1356 BS as Tablet in Patients With Type 2 Diabetes
Official Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses (2.5, 5, and 10 mg q.d. for 28 Days) of BI 1356 BS as Tablet in Patients With Type 2 Diabetes (Randomised, Double-blind, Placebo-controlled Within the Dose Groups)
Brief Summary Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS during 4 week treatment duration
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: BI 1356 BS, low dose
  • Drug: BI 1356 BS, medium dose
  • Drug: BI 1356 BS, high dose
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: BI 1356 BS, low dose
    Intervention: Drug: BI 1356 BS, low dose
  • Experimental: BI 1356 BS, medium dose
    Intervention: Drug: BI 1356 BS, medium dose
  • Experimental: BI 1356 BS, high dose
    Intervention: Drug: BI 1356 BS, high dose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2014)
77
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female postmenopausal 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
  • Male patients: Age ≥21 and Age ≤70 years
  • Female patients: Age ≥60 and Age ≤70 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 and the local legislation

Exclusion Criteria:

  • Any finding of the medical examination (including Blood Pressure, Pulse Rate and Electrocardiogram) deviating from normal and of not acceptable clinical relevance
  • Clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency NYHA (New York Heart Association) II-IV, known cardiovascular diseases including hypertension > 150/95mmHg, stroke and TIA (transient ischemic attack)
  • 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. 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 40 g/day = 5 units/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 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)
  • Change of drug dosing of allowed co-medication (anti-hypertensive agents, acetylic salicylic acid and statins) within the last 3 months
  • 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

Male 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

Female patients:

  • Positive pregnancy test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183415
Other Study ID Numbers  ICMJE 1218.3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP