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Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia.
Diabetes Obes Metab. 2013 Dec; 15(12):1154-60.DO

Abstract

AIMS

To evaluate the effects of the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin added to metformin for 12 weeks in patients with type 2 diabetes.

METHODS

This dose-ranging, double-blind, placebo-controlled trial randomized 495 participants with type 2 diabetes inadequately controlled on metformin [haemoglobin A1c (HbA1c) >7 to ≤10%] to receive 1, 5, 10, 25, or 50 mg empagliflozin once daily (QD), or placebo, or open-label sitagliptin (100 mg QD), added to metformin for 12 weeks. The primary endpoint was change in HbA1c from baseline to week 12 (empagliflozin groups versus placebo).

RESULTS

Reductions in HbA1c of -0.09 to -0.56% were observed with empagliflozin after 12 weeks, versus an increase of 0.15% with placebo (baseline: 7.8-8.1%). Compared with placebo, empagliflozin doses from 5 to 50 mg resulted in reductions in fasting plasma glucose (-2 to -28 mg/dl vs. 5 mg/dl with placebo; p < 0.0001) and body weight (-2.3 to -2.9 kg vs. -1.2 kg; p < 0.01). Frequency of adverse events was generally similar with empagliflozin (29.6-48.6%), placebo (36.6%) and sitagliptin (35.2%). Hypoglycaemia rates were very low and balanced among groups. Most frequent adverse events with empagliflozin were urinary tract infections (4.0% vs. 2.8% with placebo) and pollakiuria (2.5% vs. 1.4% with placebo). Genital infections were reported only with empagliflozin (4.0%).

CONCLUSIONS

Once daily empagliflozin as add-on therapy to metformin was well tolerated except for increased genital infections and resulted in reductions in HbA1c, fasting plasma glucose and body weight in patients with type 2 diabetes inadequately controlled on metformin monotherapy.

Authors+Show Affiliations

Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

23906374

Citation

Rosenstock, J, et al. "Efficacy and Safety of Empagliflozin, a Sodium Glucose Cotransporter 2 (SGLT2) Inhibitor, as Add-on to Metformin in Type 2 Diabetes With Mild Hyperglycaemia." Diabetes, Obesity & Metabolism, vol. 15, no. 12, 2013, pp. 1154-60.
Rosenstock J, Seman LJ, Jelaska A, et al. Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia. Diabetes Obes Metab. 2013;15(12):1154-60.
Rosenstock, J., Seman, L. J., Jelaska, A., Hantel, S., Pinnetti, S., Hach, T., & Woerle, H. J. (2013). Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia. Diabetes, Obesity & Metabolism, 15(12), 1154-60. https://doi.org/10.1111/dom.12185
Rosenstock J, et al. Efficacy and Safety of Empagliflozin, a Sodium Glucose Cotransporter 2 (SGLT2) Inhibitor, as Add-on to Metformin in Type 2 Diabetes With Mild Hyperglycaemia. Diabetes Obes Metab. 2013;15(12):1154-60. PubMed PMID: 23906374.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add-on to metformin in type 2 diabetes with mild hyperglycaemia. AU - Rosenstock,J, AU - Seman,L J, AU - Jelaska,A, AU - Hantel,S, AU - Pinnetti,S, AU - Hach,T, AU - Woerle,H J, Y1 - 2013/08/22/ PY - 2013/03/13/received PY - 2013/04/17/revised PY - 2013/07/29/accepted PY - 2013/8/3/entrez PY - 2013/8/3/pubmed PY - 2014/5/23/medline KW - HbA1c KW - SGLT2 inhibitor KW - add-on therapy KW - blood pressure KW - body weight KW - empagliflozin KW - tolerability SP - 1154 EP - 60 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 15 IS - 12 N2 - AIMS: To evaluate the effects of the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin added to metformin for 12 weeks in patients with type 2 diabetes. METHODS: This dose-ranging, double-blind, placebo-controlled trial randomized 495 participants with type 2 diabetes inadequately controlled on metformin [haemoglobin A1c (HbA1c) >7 to ≤10%] to receive 1, 5, 10, 25, or 50 mg empagliflozin once daily (QD), or placebo, or open-label sitagliptin (100 mg QD), added to metformin for 12 weeks. The primary endpoint was change in HbA1c from baseline to week 12 (empagliflozin groups versus placebo). RESULTS: Reductions in HbA1c of -0.09 to -0.56% were observed with empagliflozin after 12 weeks, versus an increase of 0.15% with placebo (baseline: 7.8-8.1%). Compared with placebo, empagliflozin doses from 5 to 50 mg resulted in reductions in fasting plasma glucose (-2 to -28 mg/dl vs. 5 mg/dl with placebo; p < 0.0001) and body weight (-2.3 to -2.9 kg vs. -1.2 kg; p < 0.01). Frequency of adverse events was generally similar with empagliflozin (29.6-48.6%), placebo (36.6%) and sitagliptin (35.2%). Hypoglycaemia rates were very low and balanced among groups. Most frequent adverse events with empagliflozin were urinary tract infections (4.0% vs. 2.8% with placebo) and pollakiuria (2.5% vs. 1.4% with placebo). Genital infections were reported only with empagliflozin (4.0%). CONCLUSIONS: Once daily empagliflozin as add-on therapy to metformin was well tolerated except for increased genital infections and resulted in reductions in HbA1c, fasting plasma glucose and body weight in patients with type 2 diabetes inadequately controlled on metformin monotherapy. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/23906374/Efficacy_and_safety_of_empagliflozin_a_sodium_glucose_cotransporter_2__SGLT2__inhibitor_as_add_on_to_metformin_in_type_2_diabetes_with_mild_hyperglycaemia_ L2 - https://doi.org/10.1111/dom.12185 DB - PRIME DP - Unbound Medicine ER -