Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: BI 10773

Study type: Interventional

Funder types: Industry

Identifiers

NCT01907113

2008-006086-86 (EudraCT Number)

1245.12

Details and patient eligibility

About

Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female subjects with type 2 diabetes
2. Renally impaired male or female subjects
3. Age 18 - 75 years
4. BMI 18 - 34 kg/m2, at least 45 kg for females (Body Mass Index)
5. Signed and dated written informed consent

Exclusion criteria

1. Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders as judged by the investigator.

2. Relevant gastrointestinal tract surgery

3. Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or relevant neurological disorders

4. 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

5. Chronic or relevant acute infections

6. History of allergy/hypersensitivity (including drug allergies) that are deemed relevant to the trial as judged by the investigator

7. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

BI 10773 / Group 2

Experimental group

Description:

Single Dose Administration (type 2 diabetes and mild renal impairment)

Treatment:

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

BI 10773 / Group 3

Experimental group

Description:

Single Dose Administration (type 2 diabetes and moderate renal impairment)

Treatment:

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

BI 10773 / Group 4

Experimental group

Description:

Single Dose Administration (severe renal impairment 8)

Treatment:

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

BI 10773 / Group 5

Experimental group

Description:

Single Dose Administration (kidney failure)

Treatment:

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

BI 10773 / Group 1

Experimental group

Description:

Single Dose Administration (type 2 diabetes and normal renal function)

Treatment:

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773

Drug: BI 10773