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

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