Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 14332 CL as Tablet in Female and Male 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: NCT02212925
Recruitment Status : Terminated
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332 CL following administration of multiple rising oral doses over 10 days in patients with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: BI 14332 CL Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses (0.5, 2.5, 10 and 20 mg q.d. for 10 Days) of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes (Randomised, Double-blind, Placebo-controlled Within the Dose Groups), Followed by a 4-week Treatment Part* (Randomised, Double-blind, Placebo-controlled) of Two Doses (Planned 5 and 20 mg) Selected on the Basis of Tolerability and DPP-4 Inhibition in the Multiple Rising Dose Part
Study Start Date : November 2006
Actual Primary Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: BI 14332 CL Drug: BI 14332 CL
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 14 days after last drug administration ]
  2. Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) [ Time Frame: up to 14 days after last drug administration ]
  3. Number of patients with clinically significant findings in ECG [ Time Frame: up to 14 days after last drug administration ]
  4. Number of patients with clinically significant findings in laboratory tests [ Time Frame: up to 14 days after last drug administration ]
  5. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 14 days after last drug administration ]

Secondary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 18 days after first drug administration ]
  2. tmax (time from dosing to maximum concentration) [ Time Frame: up to 18 days after first drug administration ]
  3. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval) [ Time Frame: up to 18 days after first drug administration ]
  4. AUCτ,1 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h after administration of the first dose) [ Time Frame: up to 18 days after first drug administration ]
  5. Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 h to 24 h) [ Time Frame: up to 11 days after first drug administration ]
  6. fe0-24 (fraction of analyte excreted in urine from time point 0 h to 24 h) [ Time Frame: up to 11 days after first drug administration ]
  7. CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 h until the time point 24 h) [ Time Frame: up to 11 days after first drug administration ]
  8. Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval) [ Time Frame: up to 18 days after first drug administration ]
  9. Cpre,N (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N) [ Time Frame: up to 18 days after first drug administration ]
  10. PTF (peak trough fluctuation) [ Time Frame: up to 18 days after first drug administration ]
    in percent

  11. RA,Cmax (accumulation ratio based on Cmax) [ Time Frame: up to 18 days after first drug administration ]
  12. RA,AUC(accumulation ratio based on AUCτ) [ Time Frame: up to 18 days after first drug administration ]
  13. Change in dipeptidyl-peptidase 4 (DPP-IV) activity [ Time Frame: baseline, up to 18 days after first drug administration ]
  14. Area under the curve of plasma glucose [ Time Frame: baseline, up to 3 hours after intake of standardized meal ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and postmenopausal or hysterectomised female patients with proven diagnosis of type 2 diabetes mellitus treated with diet and exercise only, or with one oral hypoglycaemic agent besides glitazones and who are not taking the maximum approved dose
  • Glycosylated haemoglobin A1 (HbA1c) ≥ 6.5% and ≤ 8.5 % at screening for patients treated with diet and exercise and/or one oral hypoglycaemic agent
  • Age ≥21 and Age ≤70 years (female hysterectomised and male patients) Age ≥60 and Age ≤70 years (female postmenopausal patients)
  • Body Mass Index (BMI) ≥18.5 and BMI ≤35 kg/m2

Exclusion Criteria:

  • Any finding of the medical examination (including BP, pulse rate (PR) and 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, myocardial infarction, other known cardiovascular diseases including hypertension > 140/90 mmHg, stroke and 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
  • Antidiabetic treatment with more than one oral hypoglycaemic agent or insulin or glitazones and anti-hypertensive treatment with verapamil or diltiazem
  • 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)
  • Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days 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
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

For female patients:

  • Child bearing potential
  • Positive pregnancy test
  • Lactation period

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02212925     History of Changes
Other Study ID Numbers: 1233.2
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases