Status:
COMPLETED
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male and female subjects with type 2 diabetes
- Renally impaired male or female subjects
- Age 18 - 75 years
- BMI 18 - 34 kg/m2, at least 45 kg for females (Body Mass Index)
- Signed and dated written informed consent
- Exclusion criteria:
- Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.
- Relevant gastrointestinal tract surgery
- Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts; systolic blood pressure \< 100 or \> 160 mm Hg, diastolic blood pressure \< 60 or \> 100 mm Hg, pulse rate \< 50 or \> 100 1/min
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator
- Use within 10 days prior to administration or during the trial of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation. Co medication known to inhibit or induce P-glycoprotein or CYP3A is not allowed. Inhibitors of P-glycoprotein or CYP3A (cytochrom P3A) are e.g.
- protease inhibitors, (e.g. ritonavir, lopinavir nelfinavir)
- azole antimycotics, (itraconazole, ketoconazole, miconazole)
- macrolid antibiotics, (clarithromycin, erythromycin)
- amiodarone, cimetidine, diltiazem, fluvoxamine, mibefradil, nefazodone, verapamil, tacrolimus, quinidine, reserpine, cyclosporine A Inducers of P-gp or CYP3A are e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, ri-fampin, St. John's wort, troglitazone. In dubious cases, a case by case decision will be made after consultation with the sponsor.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01907113
Start Date
July 1 2009
End Date
December 1 2009
Last Update
July 14 2014
Active Locations (2)
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1
1245.12.1 Boehringer Ingelheim Investigational Site
Kiel, Germany
2
1245.12.2 Boehringer Ingelheim Investigational Site
Neuss, Germany