Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls

This study is currently recruiting participants.
Verified April 2014 by Boehringer Ingelheim
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01867307
First received: May 21, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus and healthy controls


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Mechanistic Study to Examine the Effect of Oral Empagliflozin (25 mg q.d.) on Kinetics of Renal Glucose Reabsorption in Patients With Type 2 Diabetes Mellitus and Healthy Controls

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline of renal tubular maximum reabsorptive capacity for glucose (TmG) at end of empagliflozin treatment (Visit 12) [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Controls
healthy controls
Drug: BI 10773
open label
Experimental: Patients
patients with type 2 diabetes mellitus
Drug: Empagliflozin

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. T2DM patients and healthy controls aged =18 to <70 at Visit 1.
  2. Patients diagnosed with T2DM according to the American Diabetes Association criteria prior to informed consent who are drug-naïve
  3. T2DM patients on a stable dose of allowed concomitant medications (as determined by investigator) for 30 days prior to entering the study.
  4. T2DM patients with HbA1c between >7 and <10.0% (>53 mmol/mol and <86 mmol/mol) at Visit

Exclusion criteria:

  1. Patients with type 1 diabetes mellitus.
  2. Patients with uncontrolled hyperglycemia with a fasting plasma glucose level greater than 240 mg/dl after an overnight fast.
  3. Patients with a history of clinically significant heart disease (New York Heart Classification greater than class 3; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease (history of claudication), or pulmonary disease as determined by investigator.
  4. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867307

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Texas
1245.66.01001 Boehringer Ingelheim Investigational Site Recruiting
San Antonio, Texas, United States
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01867307     History of Changes
Other Study ID Numbers: 1245.66
Study First Received: May 21, 2013
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014