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

NCT ID: NCT01282970

Last Updated: 2014-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 135585

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

Group Type: EXPERIMENTAL

BI 135585

Intervention Type: DRUG

oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days

Placebo to BI 135585

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

Group Type: PLACEBO_COMPARATOR

Placebo to BI 135585

Intervention Type: DRUG

oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days

Interventions

BI 135585

oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days

Intervention Type: DRUG

Placebo to BI 135585

oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1283.2.1 Boehringer Ingelheim Investigational Site

Neuss, , Germany

Countries

Germany

Other Identifiers

2010-022698-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1283.2

Identifier Type: -

Identifier Source: org_study_id