Phase 2
N=37
Effect of Empagliflozin Kinetics on Renal Glucose Reabsorption in Patients With Type II Diabetes and Healthy Controls
Diabetes Mellitus, Type 2 · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01867307 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14) — -321.7; -256.9 (milligram / minute/ 1.73 square meters) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Empagliflozin (Drug); BI 10773 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14) |
-321.7; -256.9 | <0.0001 sig |
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
Eligibility Criteria
Inclusion criteria
- T2DM patients and healthy controls aged =18 to 7 and 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.
Data sourced from ClinicalTrials.gov (NCT01867307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.