BI 1356 BS in Japanese Patients With Type 2 Diabetes Mellitus

NCT02183324 | Completed Phase 2

• 1 other identifier: 1218.12
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• Global assessment of tolerability by the investigator on a 4-point scale (good, satisfactory, not satisfactory and bad)

  Day 43

• Number of patients with adverse events

  Up to day 50

• Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate)

  Up to day 50

• Number of patients with clinically relevant changes in clinical laboratory tests (haematology, clinical chemistry, and urinalysis)

  Up to day 50

Secondary Outcomes (19)

• Maximum measured concentration of the analyte in plasma (Cmax) at different time points

  Up to day 43

• Time from last dosing to the maximum concentration of the analyte in plasma (tmax) at different time points

  Up to day 43

• Area under the concentration time curve of the analyte in plasma (AUC) at different time points

  Up to day 43

• Amount of the analyte that is eliminated in urine (Ae) at different time points

  Up to day 43

• Fraction of parent drug eliminated in urine (fe) at different time points

  Up to day 43

Study Arms (4)

Low dose of BI 1356 BS

EXPERIMENTAL

Drug: Low dose of BI 1356 BS

Medium dose of BI 1356 BS

EXPERIMENTAL

Drug: Medium dose of BI 1356 BS

High dose of BI 1356 BS

EXPERIMENTAL

Drug: High dose of BI 1356 BS

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Low dose of BI 1356 BS DRUG

Low dose of BI 1356 BS

Medium dose of BI 1356 BS DRUG

Medium dose of BI 1356 BS

High dose of BI 1356 BS DRUG

High dose of BI 1356 BS

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: February 1, 2007
• Primary Completion: June 1, 2007
• Last Updated: December 28, 2017

Record last verified: 2017-12