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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01392560
First received: July 11, 2011
Last updated: May 16, 2014
Last verified: May 2014
  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:


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:

  1. Male or female subjects 18 years of age or older diagnosed with type 1 diabetes mellitus
  2. 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
  3. Subjects must be either experienced insulin pump users or be on multiple daily injections of any type of insulin

Exclusion criteria:

  1. Evidence of macroalbuminuria or leukocyte positive urinalysis at screening
  2. 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
  3. 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:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 October 23, 2014