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Pharmacodynamics and Pharmacokinetics of Empagliflozin (BI 10773) Hydrochlorothiazide and Torasemide in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01276288
First received: January 12, 2011
Last updated: September 26, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: BI 10773
Drug: hydrochlorothiazide
Drug: torasemide
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Pharmacodynamic and Pharmacokinetic Interactions Between 25 mg BI 10773 and 25 mg Hydrochlorothiazide or 5 mg Torasemide Under Steady State Conditions in Patients With Type 2 Diabetes Mellitus in an Open-label, Randomised, Cross-over Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • changes in serum and urine electrolytes [ Time Frame: baseline and after 5 days of treatment (diuretics: after 4 days of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pharmacokinetic interaction [ Time Frame: after 5 days of combined treatment ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Reference 1
administration of BI 10773 once daily for 5 days (20 patients)
 Drug: BI 10773
multiple oral doses
Active Comparator: Reference 2
administration of hydrochlorothiazide (HTC) once daily for 4 days (10 patients)
 Drug: hydrochlorothiazide
multiple oral doses
Active Comparator: Reference 3
administration of torasemide (TOR) once daily for 4 days (10 patients)
 Drug: torasemide
multiple oral doses
Experimental: Test 1
administration of BI 10773 + HTC once daily for 5 days (10 patients)
 Drug: hydrochlorothiazide
multiple oral doses
Drug: BI 10773
multiple oral doses
Experimental: Test 2
administration of BI 10773 + TOR once daily for 5 days (10 patients)
 Drug: BI 10773
multiple oral doses
Drug: torasemide
multiple oral doses

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

1. male and female patients of type 2 diabetes

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276288

Locations
Germany
1245.42.1 Boehringer Ingelheim Investigational Site
Neuss, Germany
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01276288     History of Changes
Other Study ID Numbers: 1245.42, 2010-019624-31
Study First Received: January 12, 2011
Last Updated: September 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydrochlorothiazide
Torsemide
Diuretics
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013