Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
Completed · Phase 2
Conditions studied: Diabetes Mellitus, Type 2, Healthy
In brief
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
Key facts
- Study ID
- NCT01867307
- Run by
- Boehringer Ingelheim
- People needed
- 39
- Starts
- 2013-06-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2017-05-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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