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A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes.
Diabetes Obes Metab. 2013 Aug; 15(8):721-8.DO

Abstract

AIM

This Phase IIb, randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes.

METHODS

Four hundred and eight patients (treatment-naïve or after a 4-week wash-out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open-label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks.

RESULTS

After 12 weeks' treatment, empagliflozin showed dose-dependent reductions in HbA1c from baseline [5 mg: -0.4%, 10 mg: -0.5%, 25 mg: -0.6%; all doses p < 0.0001 vs. placebo (+0.09%)]. Fasting plasma glucose (FPG) decreased with empagliflozin [5 mg: -1.29 mmol/l, 10 mg: -1.61 mmol/l, 25 mg: -1.72 mmol/l; all doses p < 0.0001 vs. placebo (+0.04 mmol/l)]. Body weight decreased in all empagliflozin groups (all doses p < 0.001 vs. placebo). The incidence of adverse events (AEs) was similar in the placebo (32.9%) and empagliflozin (29.1%) groups. The most frequently reported AEs on empagliflozin were pollakiuria (3.3% vs. 0% for placebo), thirst (3.3% vs. 0% for placebo) and nasopharyngitis (2.0% vs. 1.2% for placebo). AEs consistent with urinary tract infections (UTIs) were reported in four (1.6%) patients on empagliflozin vs. one (1.2%) on placebo. Genital infections were reported in five (2%) patients on empagliflozin vs. 0% on placebo. No UTIs or genital infections led to premature discontinuation.

CONCLUSIONS

In patients with type 2 diabetes, empagliflozin resulted in dose-dependent, clinically meaningful reductions in HbA1c and FPG, and reductions in body weight compared with placebo. Empagliflozin was well-tolerated with a favourable safety profile.

Authors+Show Affiliations

Department of Internal Medicine, University of Pisa, Pisa, Italy. ferranni@ifc.cnr.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23398530

Citation

Ferrannini, E, et al. "A Phase IIb, Randomized, Placebo-controlled Study of the SGLT2 Inhibitor Empagliflozin in Patients With Type 2 Diabetes." Diabetes, Obesity & Metabolism, vol. 15, no. 8, 2013, pp. 721-8.
Ferrannini E, Seman L, Seewaldt-Becker E, et al. A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes. Diabetes Obes Metab. 2013;15(8):721-8.
Ferrannini, E., Seman, L., Seewaldt-Becker, E., Hantel, S., Pinnetti, S., & Woerle, H. J. (2013). A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes. Diabetes, Obesity & Metabolism, 15(8), 721-8. https://doi.org/10.1111/dom.12081
Ferrannini E, et al. A Phase IIb, Randomized, Placebo-controlled Study of the SGLT2 Inhibitor Empagliflozin in Patients With Type 2 Diabetes. Diabetes Obes Metab. 2013;15(8):721-8. PubMed PMID: 23398530.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Phase IIb, randomized, placebo-controlled study of the SGLT2 inhibitor empagliflozin in patients with type 2 diabetes. AU - Ferrannini,E, AU - Seman,L, AU - Seewaldt-Becker,E, AU - Hantel,S, AU - Pinnetti,S, AU - Woerle,H J, Y1 - 2013/03/04/ PY - 2012/12/03/received PY - 2012/12/28/revised PY - 2013/02/04/accepted PY - 2013/2/13/entrez PY - 2013/2/13/pubmed PY - 2014/3/13/medline KW - BI 10773 KW - FPG KW - HbA1c KW - SGLT2 inhibitor KW - body weight KW - empagliflozin KW - tolerability SP - 721 EP - 8 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 15 IS - 8 N2 - AIM: This Phase IIb, randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety, tolerability and pharmacokinetics of empagliflozin in patients with type 2 diabetes. METHODS: Four hundred and eight patients (treatment-naïve or after a 4-week wash-out period) were randomized to receive empagliflozin 5, 10 or 25 mg once daily, placebo or open-label metformin for 12 weeks. The primary endpoint was change in haemoglobin A1c (HbA1c) after 12 weeks. RESULTS: After 12 weeks' treatment, empagliflozin showed dose-dependent reductions in HbA1c from baseline [5 mg: -0.4%, 10 mg: -0.5%, 25 mg: -0.6%; all doses p < 0.0001 vs. placebo (+0.09%)]. Fasting plasma glucose (FPG) decreased with empagliflozin [5 mg: -1.29 mmol/l, 10 mg: -1.61 mmol/l, 25 mg: -1.72 mmol/l; all doses p < 0.0001 vs. placebo (+0.04 mmol/l)]. Body weight decreased in all empagliflozin groups (all doses p < 0.001 vs. placebo). The incidence of adverse events (AEs) was similar in the placebo (32.9%) and empagliflozin (29.1%) groups. The most frequently reported AEs on empagliflozin were pollakiuria (3.3% vs. 0% for placebo), thirst (3.3% vs. 0% for placebo) and nasopharyngitis (2.0% vs. 1.2% for placebo). AEs consistent with urinary tract infections (UTIs) were reported in four (1.6%) patients on empagliflozin vs. one (1.2%) on placebo. Genital infections were reported in five (2%) patients on empagliflozin vs. 0% on placebo. No UTIs or genital infections led to premature discontinuation. CONCLUSIONS: In patients with type 2 diabetes, empagliflozin resulted in dose-dependent, clinically meaningful reductions in HbA1c and FPG, and reductions in body weight compared with placebo. Empagliflozin was well-tolerated with a favourable safety profile. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/23398530/A_Phase_IIb_randomized_placebo_controlled_study_of_the_SGLT2_inhibitor_empagliflozin_in_patients_with_type_2_diabetes_ L2 - https://doi.org/10.1111/dom.12081 DB - PRIME DP - Unbound Medicine ER -