A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects
Summary
An open-label, phase II study to assess the acute and chronic effects of empagliflozin (BI 10773)on fasting and postprandial glucose homeostasis in patients with IGT and type 2 diabetes mellitus and assess the acute effects of empagliflozin in healthy subjects.
Timeline
- Start
- 2010-11
- Primary completion
- 2013-07
- Completion
- 2013-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); T2DM Naive vs T2DM Metformin; p = 0.2790; Mean Difference (Final Values) 0.19 (95% CI -0.16 to 0.55); ANCOVA NCT01248364 ↗
registry analysis (superiority or other test); T2DM Naive vs T2DM Metformin; p = 0.2438; Mean Difference (Final Values) 0.23 (95% CI -0.16 to 0.62); ANCOVA NCT01248364 ↗
registry analysis (superiority or other test); T2DM Naive vs T2DM Metformin; p = 0.0552; Mean Difference (Final Values) -1.58 (95% CI -3.20 to 0.04); ANCOVA NCT01248364 ↗
registry analysis (superiority or other test); T2DM Naive vs T2DM Metformin; p = 0.7561; Mean Difference (Final Values) 0.31 (95% CI -1.66 to 2.27); ANCOVA NCT01248364 ↗
Publications
- Ferrannini E, Baldi S, Frascerra S, Astiarraga B, Barsotti E, Clerico A, Muscelli E. Renal Handling of Ketones in Response to Sodium-Glucose Cotransporter 2 Inhibition in Patients With Type 2 Diabetes. Diabetes Care. 2017 Jun;40(6):771-776. doi: 10.2337/dc16-2724. Epub 2017 Mar 21.
- Muscelli E, Astiarraga B, Barsotti E, Mari A, Schliess F, Nosek L, Heise T, Broedl UC, Woerle HJ, Ferrannini E. Metabolic consequences of acute and chronic empagliflozin administration in treatment-naive and metformin pretreated patients with type 2 diabetes. Diabetologia. 2016 Apr;59(4):700-8. doi: 10.1007/s00125-015-3845-8. Epub 2015 Dec 24.
- Ferrannini E, Muscelli E, Frascerra S, Baldi S, Mari A, Heise T, Broedl UC, Woerle HJ. Metabolic response to sodium-glucose cotransporter 2 inhibition in type 2 diabetic patients. J Clin Invest. 2014 Feb;124(2):499-508. doi: 10.1172/JCI72227. Epub 2014 Jan 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |