Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration - Full Text View

Purpose

This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.

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


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label 8-week Adjunctive-to-insulin and Renal Mechanistic Pilot Trial of BI 10773 in Type 1 Diabetes Mellitus (the ATIRMA Trial)

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Medicines Diabetes Type 1 Hyperglycemia

Drug Information available for: Empagliflozin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:

Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia


Enrollment:	52
Study Start Date:	June 2011
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BI 10773 Oral once daily	Drug: BI 10773 Oral once daily

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Male or female subjects 18 years of age or older diagnosed with type 1 diabetes mellitus
Glycated hemoglobin (HbA1C) of 6.5% to 11.0% and an estimated glomerular filtration rate (eGFR) greater or equal to 60 ml/min/1.73m² at screening
Subjects must be either experienced insulin pump users or be on multiple daily injections of any type of insulin

Exclusion criteria:

Evidence of macroalbuminuria or leukocyte positive urinalysis at screening
Any concomitant medication known to interfere with renin-angiotensin-aldosterone system (RAAS) activity or treatment with any other drugs to reduce blood glucose other than insulin
History of macrovascular disease or any other disease which would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392560

Locations


Canada, Ontario
1245.46.10001 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada

Sponsors and Collaborators

Boehringer Ingelheim

Investigators


Study Chair:	Boehringer Ingelheim	Boehringer Ingelheim

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Perkins BA, Cherney DZ, Partridge H, Soleymanlou N, Tschirhart H, Zinman B, Fagan NM, Kaspers S, Woerle HJ, Broedl UC, Johansen OE. Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial. Diabetes Care. 2014 May;37(5):1480-3. doi: 10.2337/dc13-2338. Epub 2014 Mar 4.

Cherney DZ, Perkins BA, Soleymanlou N, Maione M, Lai V, Lee A, Fagan NM, Woerle HJ, Johansen OE, Broedl UC, von Eynatten M. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation. 2014 Feb 4;129(5):587-97. doi: 10.1161/CIRCULATIONAHA.113.005081. Epub 2013 Dec 13.


Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01392560 History of Changes
Other Study ID Numbers:	1245.46
Study First Received:	July 11, 2011
Results First Received:	May 16, 2014
Last Updated:	May 16, 2014
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 1 Autoimmune Diseases Endocrine System Diseases	Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases

ClinicalTrials.gov processed this record on March 03, 2015