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

Boehringer Ingelheim

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Placebo

Drug: BI 1356 BS - single rising dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT02183350

1218.2

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

Male

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)
Any laboratory value outside the reference range that is of not acceptable clinical relevance
Change of drug dosing of allowed co-medication (anti-hypertensive agents, acetylic salicylic acid and statins) within the last 3 months
Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 120 ms or QTcB > 450 ms or QT >500 ms
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