Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes

Diabetes Research and Clinical Practice

Volumn 110, Issue 1, 2015, Pages 82-90

  Haering, Hans Ulrich ^a   Merker, Ludwig ^b   Christiansen, Anita Vedel ^c   Roux, Flavien ^d   Salsali, Afshin ^e   Kim, Gabriel ^c   Meinicke, Thomas ^c   Woerle, Hans J ^c   Broedl, Uli C ^c  

^a UNIVERSITY OF TÜBINGEN   (Germany)

^b Diabetes und Nierenzentrum   (Germany)

^c BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^d BOEHRINGER INGELHEIM   (France)

^e BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

Empagliflozin; Glycaemic control; Metformin; SGLT2 inhibitor; Sulphonylurea

Indexed keywords

EMPAGLIFLOZIN; HEMOGLOBIN A1C; METFORMIN; PLACEBO; SULFONYLUREA; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; GLUCOSE BLOOD LEVEL; GLUCOSIDE; GLYCOSYLATED HEMOGLOBIN; SULFONYLUREA DERIVATIVE;

ACUTE HEART INFARCTION; ADD ON THERAPY; ARTICLE; BACKACHE; BODY WEIGHT; BRONCHITIS; CONTROLLED STUDY; COUGHING; DIZZINESS; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GENITAL TRACT INFECTION; GLYCEMIC CONTROL; HEADACHE; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INFLUENZA; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; RHINOPHARYNGITIS; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URIC ACID BLOOD LEVEL; URINARY TRACT INFECTION; WEIGHT REDUCTION; ADULT; AGED; BLOOD; BLOOD PRESSURE; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DIABETES MELLITUS, TYPE 2; DOUBLE BLIND PROCEDURE; DRUG EFFECTS; GLUCOSE BLOOD LEVEL; METABOLISM; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; PROCEDURES; RANDOMIZED CONTROLLED TRIAL;

ADULT; AGED; BENZHYDRYL COMPOUNDS; BLOOD GLUCOSE; BLOOD PRESSURE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GLUCOSIDES; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; MALE; METFORMIN; MIDDLE AGED; SULFONYLUREA COMPOUNDS; TREATMENT OUTCOME;

EID: 84943200890     PISSN: 01688227     EISSN: 18728227     Source Type: Journal    
DOI: 10.1016/j.diabres.2015.05.044     Document Type: Article

References (21)

1. Inzucchi S.E., Bergenstal R.M., Buse J.B., Diamant M., Ferrannini E., Nauck M., et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012, 35:1364-1379.
2. DeFronzo R.A. Banting lecture from the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes 2009, 58:773-795.
3. Riedel A.A., Heien H., Wogen J., Plauschinat C.A. Secondary failure of glycemic control for patients adding thiazolidinedione or sulfonylurea therapy to a metformin regimen. Am J Manage Care 2007, 13:457-463.
4. Grempler R., Thomas L., Eckhardt M., Himmelsbach F., Sauer A., Sharp D.E., et al. Empagliflozin, a novel selective sodium glucose cotransporter-2 (SGLT-2) inhibitor: characterisation and comparison with other SGLT-2 inhibitors. Diabetes Obes Metab 2012, 14:83-90.
5. Heise T., Seewaldt-Becker E., Macha S., Hantel S., Pinnetti S., Seman L., et al. Safety, tolerability, pharmacokinetics and pharmacodynamics following 4 weeks' treatment with empagliflozin once daily in patients with type 2 diabetes. Diabetes Obes Metab 2013, 15:613-621.
6. DeFronzo R.A., Davidson J.A., del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab 2012, 14:5-14.
7. Roden M., Weng J., Eilbracht J., Delafont B., Kim G., Woerle H.J., et al. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol 2013, 1:208-219.
8. Barnett A.H., Mithal A., Manassie J., Jones R., Rattunde H., Woerle H.J., et al. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol 2014, 2:369-384.
9. Haering H.U., Merker L., Seewaldt-Becker E., Weimer M., Meinicke T., Woerle H.J., et al. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care 2013, 36:3396-3404.
10. Haering H.U., Merker L., Seewaldt-Becker E., Weimer M., Meinicke T., Broedl U.C., et al. Empagliflozin as add-on to metformin in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care 2014, 37:1650-1659.
11. Kovacs C.S., Seshiah V., Swallow R., Jones R., Rattunde H., Woerle H.J., et al. Empagliflozin improves glycaemic and weight control as add-on therapy to pioglitazone or pioglitazone plus metformin in patients with type 2 diabetes: a 24-week, randomized, placebo-controlled trial. Diabetes Obes Metab 2014, 16:147-158.
12. Rosenstock J., Jelaska A., Frappin G., Salsali A., Kim G., Woerle H.J., et al. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care 2014, 37:1815-1823.
13. American Diabetes Association American Diabetes Association Standards of medical care in diabetes-2013. Diabetes Care 2013, 36(Suppl 1):S11-S66.
14. Marrett E., Stargardt T., Mavros P., Alexander C.M. Patient-reported outcomes in a survey of patients treated with oral antihyperglycaemic medications: associations with hypoglycaemia and weight gain. Diabetes Obes Metab 2009, 11:1138-1144.
15. McIntosh B., Cameron C., Singh S.R., Yu C., Dolovich L., Houlden R. Choice of therapy in patients with type 2 diabetes inadequately controlled with metformin and a sulphonylurea: a systematic review and mixed-treatment comparison meta-analysis. Open Med 2012, 6:e62-e74.
16. Hirst J.A., Farmer A.J., Dyar A., Lung T.W., Stevens R.J. Estimating the effect of sulfonylurea on HbA1c in diabetes: a systematic review and meta-analysis. Diabetologia 2013, 56:973-984.
17. European Medicines Agency Jardiance (empagliflozin) summary of product characteristics 2014, 〈http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002677/WC500168592.pdf〉 (Last accessed 13 October 2014).
18. US Food and Drug Administration Jardiance (empagliflozin) highlights of prescribing information 2014, 〈http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204629s000lbl.pdf〉. (Last accessed 13 October 2014).
19. Blonde L., Klein E.J., Han J., Zhang B., Mac S.M., Poon T.H., et al. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes Obes Metab 2006, 8:436-447.
20. Hollander P.L., Li J., Frederich R., Allen E., Chen R. Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus. Diab Vasc Dis Res 2011, 8:125-135. CV181013 Investigators.
21. Strojek K., Yoon K-H., Hruba V., Sugg J., Langkilde A.M., Parikh S. Dapagliflozin added to glimepiride in patients with type 2 diabetes mellitus sustains glycemic control and weight loss over 48 weeks: a randomized, double-blind, parallel-group, placebo-controlled trial. Diabetes Ther 2014, 5:267-283.