Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 135585 XX in Patients With Type 2 Diabetes

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo to BI 135585; Drug: BI 135585

Study type: Interventional

Funder types: Industry

Identifiers

NCT01282970

1283.2

2010-022698-32 (EudraCT Number)

Details and patient eligibility

About

The objective of this study is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 135585 XX following multiple dose administration over 14 days

Enrollment: 72 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Male and postmenopausal or surgically sterilised female patients with an established diagnosis of type 2 diabetes mellitus prior to informed consent
2. Antidiabetic treatment with diet and exercise alone or with not more than one oral hypoglycaemic drug except glitazones, glucagon-like peptide 1 (GLP-1) analogues or dipeptidyl-peptidase 4 (DPP-4) inhibitors.
3. Antidiabetic treatment unchanged for 12 weeks prior to informed consent
4. Glycosylated haemoglobin A1 (HbA1c) ≤ 8.5% at screening
5. Age ≥ 20 and age ≤ 70 years
6. BMI ≥ 25 and BMI ≤ 40 kg/m2 (Body Mass Index)
7. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of not acceptable clinical relevance
2. Myocardial infarction, stroke or transient ischemic attack within 6 months prior to informed consent
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders besides type 2 diabetes, hyperlipidaemia or medically treated hypertension
4. Gastrointestinal tract surgery that might affect absorption and elimination of drugs
5. Diseases of the central nerve system (such as epilepsy) or psychiatric disorders or relevant neurological disorders besides polyneuropathy
6. Chronic or relevant acute infections (e.g. HIV, hepatitis)
7. History of allergy/hypersensitivity (including allergy to drug or its excipients) that are deemed relevant to subject's safety or the trial by the investigator
8. Intake of drugs with a long half-life (> 24 hours) within one month prior to administration of the trial drug except for allowed co-medication
9. Treatment with glitazones, GLP-1 analogues, insulin, DPP-4 inhibitors, systemic or inhaled glucocorticoids, or anti-obesity drugs (e.g. orlistat) within 12 weeks prior to informed consent
10. Sensitive CYP3A4 substrates (e.g. simvastatin, lovastatin, verapamil, budesonide, buspirone, eplerenone , eletriptan, felodipine, fluticasone, midazolam, saquinavir, sildenafil, vardenafil) or CYP3A4 substrates with narrow therapeutic range (e.g. cyclosporine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus, terfenadine) or drugs that prolong the QT/QTc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to first administration of the trial drug
11. other exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

BI 135585

Experimental group

Description:

once daily doses as oral solution or tablet formulation over 14 days

Treatment:

Drug: BI 135585

Placebo to BI 135585

Placebo Comparator group

Description:

once daily doses as oral solution or tablet formulation over 14 days

Treatment:

Drug: Placebo to BI 135585