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

NCT02183415 | Completed Phase 1

• 1 other identifier: 1218.3
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1356 BS during 4 week treatment duration

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Assessment of tolerability by investigator on a 4-point scale

  Day 50

• Incidence of adverse events

  up to 50 days

• Number of patients with abnormal changes in clinical laboratory parameters

  Baseline, up to day 50

Secondary Outcomes (19)

• Cmax (maximum concentration of the analyte in plasma)

  before and up to 43 days after first study drug administration

• tmax (time from dosing to maximum concentration)

  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

  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)

  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)

  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

Study Arms (4)

BI 1356 BS, low dose

EXPERIMENTAL

Drug: BI 1356 BS, low dose

BI 1356 BS, medium dose

EXPERIMENTAL

Drug: BI 1356 BS, medium dose

BI 1356 BS, high dose

EXPERIMENTAL

Drug: BI 1356 BS, high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1356 BS, low dose DRUG

BI 1356 BS, low dose

BI 1356 BS, medium dose DRUG

BI 1356 BS, medium dose

BI 1356 BS, high dose DRUG

BI 1356 BS, high dose

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:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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 1
• 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: August 1, 2005
• Primary Completion: January 1, 2006
• Last Updated: July 8, 2014

Record last verified: 2014-07