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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Healthy

Diabetes Mellitus, Type 2

Treatments

Drug: BI 10773

Drug: Empagliflozin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01867307

1245.66

Details and patient eligibility

About

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

Enrollment

39 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.