- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01867307
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
March 31, 2017 updated by: Boehringer Ingelheim
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States
- Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- T2DM patients and healthy controls aged =18 to <70 at Visit 1.
- Patients diagnosed with T2DM according to the American Diabetes Association criteria prior to informed consent who are drug-naïve
- T2DM patients on a stable dose of allowed concomitant medications (as determined by investigator) for 30 days prior to entering the study.
- T2DM patients with HbA1c between >7 and <10.0% (>53 mmol/mol and <86 mmol/mol) at Visit
Exclusion criteria:
- Patients with type 1 diabetes mellitus.
- Patients with uncontrolled hyperglycemia with a fasting plasma glucose level greater than 240 mg/dl after an overnight fast.
- 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.
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy Controls
healthy controls
|
open label
|
EXPERIMENTAL: Patients
patients with type 2 diabetes mellitus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)
Time Frame: Baseline and Day 14
|
Change from baseline of renal tubular maximum reabsorptive capacity for glucose (TmG) at end of empagliflozin treatment (Day 14). Per-protocol set (PPS): PPS consisted of all subjects and patients in the TS who completed the treatment day 14 clamping study without any relevant deviations either in their treatment regimen or in the performance and timing of the measurements. |
Baseline and Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Abdul-Ghani M, Al Jobori H, Daniele G, Adams J, Cersosimo E, Triplitt C, DeFronzo RA. Inhibition of Renal Sodium-Glucose Cotransport With Empagliflozin Lowers Fasting Plasma Glucose and Improves beta-Cell Function in Subjects With Impaired Fasting Glucose. Diabetes. 2017 Sep;66(9):2495-2502. doi: 10.2337/db17-0055. Epub 2017 Jun 13.
- Al-Jobori H, Daniele G, Cersosimo E, Triplitt C, Mehta R, Norton L, DeFronzo RA, Abdul-Ghani M. Empagliflozin and Kinetics of Renal Glucose Transport in Healthy Individuals and Individuals With Type 2 Diabetes. Diabetes. 2017 Jul;66(7):1999-2006. doi: 10.2337/db17-0100. Epub 2017 Apr 20.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (ACTUAL)
October 1, 2015
Study Completion (ACTUAL)
October 1, 2015
Study Registration Dates
First Submitted
May 21, 2013
First Submitted That Met QC Criteria
May 29, 2013
First Posted (ESTIMATE)
June 4, 2013
Study Record Updates
Last Update Posted (ACTUAL)
May 11, 2017
Last Update Submitted That Met QC Criteria
March 31, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1245.66
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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