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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867307
• Other study ID #: 1245.66
• Status: Completed
• Phase: Phase 2
• First received: May 21, 2013
• Last updated: March 31, 2017
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

Drug:
• Empagliflozin

• BI 10773
open label

Locations

Country	Name	City	State
United States	Boehringer Ingelheim Investigational Site	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (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

External Links

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