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BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02183324
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Low dose of BI 1356 BS Drug: Medium dose of BI 1356 BS Drug: High dose of BI 1356 BS Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : February 2007
Actual Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
Experimental: Low dose of BI 1356 BS Drug: Low dose of BI 1356 BS
Experimental: Medium dose of BI 1356 BS Drug: Medium dose of BI 1356 BS
Experimental: High dose of BI 1356 BS Drug: High dose of BI 1356 BS
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Global assessment of tolerability by the investigator on a 4-point scale (good, satisfactory, not satisfactory and bad) [ Time Frame: Day 43 ]
  2. Number of patients with adverse events [ Time Frame: Up to day 50 ]
  3. Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate) [ Time Frame: Up to day 50 ]
  4. Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, and urinalysis) [ Time Frame: Up to day 50 ]

Secondary Outcome Measures :
  1. Maximum measured concentration of the analyte in plasma (Cmax) at different time points [ Time Frame: Up to day 43 ]
  2. Time from last dosing to the maximum concentration of the analyte in plasma (tmax) at different time points [ Time Frame: Up to day 43 ]
  3. Area under the concentration time curve of the analyte in plasma (AUC) at different time points [ Time Frame: Up to day 43 ]
  4. Amount of the analyte that is eliminated in urine (Ae) at different time points [ Time Frame: Up to day 43 ]
  5. Fraction of parent drug eliminated in urine (fe) at different time points [ Time Frame: Up to day 43 ]
  6. Renal clearance of the analyte (CLR) at different time points [ Time Frame: Up to day 43 ]
  7. 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 ]
  8. Average concentration of the analyte in plasma at steady state (Cavg) [ Time Frame: After the last dose on day 28 up to day 43 ]
  9. 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 ]
  10. Terminal rate constant in plasma at steady state (λz,ss) [ Time Frame: After last dose on day 28 up to day 43 ]
  11. 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 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. Calculation of accumulation ratio of the analyte in plasma based on Cmax (RA,Cmax) [ Time Frame: Up to day 43 ]
  16. Calculation of accumulation ratio of the analyte in plasma based on AUCτ (RA,AUCτ) [ Time Frame: Up to day 43 ]
  17. Minimum dipeptidyl peptidase IV (DPP-IV) activity (Emin) at different time points [ Time Frame: Up to day 43 ]
  18. Time to reach minimum DPP-IV activity (tmin) at different time points [ Time Frame: Up to day 43 ]
  19. DPP-IV activity at different time points [ Time Frame: Up to day 43 ]


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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183324    
Other Study ID Numbers: 1218.12
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action