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

NCT02183350 | Completed Phase 1

• 1 other identifier: 1218.2
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the current study was to investigate the safety and tolerability of BI 1356 BS following administration of multiple rising oral doses of 1 mg, 2.5 mg, 5 mg, and 10 mg over 12 days in male patients with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (6)

• Number of patients with adverse events

  up to 28 days

• Number of patients with abnormal findings in physical examination

  up to 28 days

• Number of patients with abnormal changes in Vital signs (blood pressure (BP), pulse rate (PR))

  up to 28 days

• Number of patients with abnormal changes in 12-lead ECG (electrocardiogram)

  up to 28 days

• Number of patients with abnormal changes in laboratory parameters

  up to 28 days

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

  up to 28 days

Secondary Outcomes (18)

• Cmax (maximum concentration of the analyte in plasma)

  predose, up to 456 h

• tmax (time from dosing to maximum concentration)

  predose, up to 456 h

• AUC (area under the concentration-time curve of the analyte in plasma)

  predose, up to 456 h

• Ae (amount of analyte that is eliminated in urine)

  predose, up to 456 h

• fe (fraction of analyte excreted in urine)

  up to 288 h

Study Arms (2)

BI 1356 BS - single rising dose

EXPERIMENTAL

Drug: BI 1356 BS - single rising dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1356 BS - single rising dose DRUG

BI 1356 BS - single rising dose

Placebo DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Male 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
• Age ≥21 and Age ≤65 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 GCP and the local legislation

You may not qualify if:

• Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (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, known cardiovascular diseases including hypertension \> 160/110 mmHg, stroke and Transient ischaemic attack (TIA)
• 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. 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 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 60 g/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

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 2005
• Primary Completion: August 1, 2005
• Last Updated: July 8, 2014

Record last verified: 2014-07