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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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 controls

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborator: Eli Lilly and Company
• Treatments: Empagliflozin

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.