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Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: hydrochlorothiazide
Drug: torasemide
Drug: BI 10773

Study type

Interventional

Funder types

Industry

Identifiers

NCT01276288
2010-019624-31 (EudraCT Number)
1245.42

Details and patient eligibility

About

The primary objective of the study is to investigate the effect of BI 10773, hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should be assessed.

Enrollment

23 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

  1. male and female patients of type 2 diabetes

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

23 participants in 5 patient groups

Reference 1
Active Comparator group
Description:
administration of BI 10773 once daily for 5 days (20 patients)
Treatment:
Drug: BI 10773
Drug: BI 10773
Drug: BI 10773
Reference 2
Active Comparator group
Description:
administration of hydrochlorothiazide (HTC) once daily for 4 days (10 patients)
Treatment:
Drug: hydrochlorothiazide
Drug: hydrochlorothiazide
Reference 3
Active Comparator group
Description:
administration of torasemide (TOR) once daily for 4 days (10 patients)
Treatment:
Drug: torasemide
Drug: torasemide
Test 1
Experimental group
Description:
administration of BI 10773 + HTC once daily for 5 days (10 patients)
Treatment:
Drug: BI 10773
Drug: BI 10773
Drug: hydrochlorothiazide
Drug: hydrochlorothiazide
Drug: BI 10773
Test 2
Experimental group
Description:
administration of BI 10773 + TOR once daily for 5 days (10 patients)
Treatment:
Drug: BI 10773
Drug: torasemide
Drug: torasemide
Drug: BI 10773
Drug: BI 10773

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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