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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 10773 / Group 2

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

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

oral administration

BI 10773 / Group 3

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

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

oral administration

BI 10773 / Group 4

Single Dose Administration (severe renal impairment 8)

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

oral administration

BI 10773 / Group 5

Single Dose Administration (kidney failure)

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

oral administration

BI 10773 / Group 1

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

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

oral administration

Interventions

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BI 10773

oral administration

Intervention Type DRUG

BI 10773

oral administration

Intervention Type DRUG

BI 10773

oral administration

Intervention Type DRUG

BI 10773

oral administration

Intervention Type DRUG

BI 10773

oral administration

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No