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

NCT ID: NCT01276288

Last Updated: 2014-09-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

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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

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reference 1

administration of BI 10773 once daily for 5 days (20 patients)

Group Type ACTIVE_COMPARATOR

BI 10773

Intervention Type DRUG

multiple oral doses

Reference 2

administration of hydrochlorothiazide (HTC) once daily for 4 days (10 patients)

Group Type ACTIVE_COMPARATOR

hydrochlorothiazide

Intervention Type DRUG

multiple oral doses

Reference 3

administration of torasemide (TOR) once daily for 4 days (10 patients)

Group Type ACTIVE_COMPARATOR

torasemide

Intervention Type DRUG

multiple oral doses

Test 1

administration of BI 10773 + HTC once daily for 5 days (10 patients)

Group Type EXPERIMENTAL

hydrochlorothiazide

Intervention Type DRUG

multiple oral doses

BI 10773

Intervention Type DRUG

multiple oral doses

Test 2

administration of BI 10773 + TOR once daily for 5 days (10 patients)

Group Type EXPERIMENTAL

BI 10773

Intervention Type DRUG

multiple oral doses

torasemide

Intervention Type DRUG

multiple oral doses

Interventions

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BI 10773

multiple oral doses

Intervention Type DRUG

hydrochlorothiazide

multiple oral doses

Intervention Type DRUG

torasemide

multiple oral doses

Intervention Type DRUG

BI 10773

multiple oral doses

Intervention Type DRUG

torasemide

multiple oral doses

Intervention Type DRUG

BI 10773

multiple oral doses

Intervention Type DRUG

hydrochlorothiazide

multiple oral doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. male and female patients of type 2 diabetes
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1245.42.1 Boehringer Ingelheim Investigational Site

Neuss, , Germany

Site Status

Countries

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Germany

References

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Heise T, Jordan J, Wanner C, Heer M, Macha S, Mattheus M, Lund SS, Woerle HJ, Broedl UC. Pharmacodynamic Effects of Single and Multiple Doses of Empagliflozin in Patients With Type 2 Diabetes. Clin Ther. 2016 Oct;38(10):2265-2276. doi: 10.1016/j.clinthera.2016.09.001. Epub 2016 Sep 28.

Reference Type DERIVED
PMID: 27692976 (View on PubMed)

Heise T, Jordan J, Wanner C, Heer M, Macha S, Mattheus M, Lund SS, Woerle HJ, Broedl UC. Acute Pharmacodynamic Effects of Empagliflozin With and Without Diuretic Agents in Patients With Type 2 Diabetes Mellitus. Clin Ther. 2016 Oct;38(10):2248-2264.e5. doi: 10.1016/j.clinthera.2016.08.008. Epub 2016 Sep 22.

Reference Type DERIVED
PMID: 27666126 (View on PubMed)

Heise T, Mattheus M, Woerle HJ, Broedl UC, Macha S. Assessing pharmacokinetic interactions between the sodium glucose cotransporter 2 inhibitor empagliflozin and hydrochlorothiazide or torasemide in patients with type 2 diabetes mellitus: a randomized, open-label, crossover study. Clin Ther. 2015 Apr 1;37(4):793-803. doi: 10.1016/j.clinthera.2014.12.018. Epub 2015 Jan 28.

Reference Type DERIVED
PMID: 25636696 (View on PubMed)

Other Identifiers

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2010-019624-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1245.42

Identifier Type: -

Identifier Source: org_study_id

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