Status:
COMPLETED
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Healthy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 cont...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01867307
Start Date
June 1 2013
End Date
October 1 2015
Last Update
May 11 2017
Active Locations (1)
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1
Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States