Empagliflozin as adjunctive to insulin therapyin type 1 diabetes: The EASE trials

Diabetes Care

Volumn 41, Issue 12, 2018, Pages 2560-2569

  Rosenstock, Julio ^a   Marquard, Jan ^b   Laffel, Lori M ^c   Neubacher, Dietmar ^b   Kaspers, Stefan ^b   Cherney, David Z ^d   Zinman, Bernard ^e   Skyler, Jay S ^f   George, Jyothis ^b   Soleymanlou, Nima ^g   Perkins, Bruce A ^e  

^a Dallas Diabetes and Endocrine Center at Medical City   (United States)

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

^c HARVARD MEDICAL SCHOOL   (United States)

^d UNIVERSITY OF TORONTO   (Canada)

^e MOUNT SINAI HOSPITAL   (Canada)

^f UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^g BOEHRINGER INGELHEIM CANADA LTD   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

EMPAGLIFLOZIN; GLUCOSE; GLYCOSYLATED HEMOGLOBIN; PLACEBO; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; GLUCOSIDE; INSULIN;

ADULT; ARTICLE; BODY WEIGHT; CLINICAL EVALUATION; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATALITY; FEMALE; FRACTURE; GENITAL TRACT INFECTION; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; KETOACIDOSIS; KIDNEY DISEASE; LEG AMPUTATION; LIVER DISEASE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; RISK REDUCTION; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; URINARY TRACT INFECTION; AGED; BLOOD; BODY WEIGHT LOSS; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DRUG EFFECT; GLUCOSE BLOOD LEVEL; METABOLISM; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADULT; AGED; BENZHYDRYL COMPOUNDS; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 1; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GLUCOSIDES; GLYCATED HEMOGLOBIN A; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; MALE; MIDDLE AGED; PLACEBOS; TREATMENT OUTCOME; WEIGHT LOSS;

EID: 85056803685     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc18-1749     Document Type: Article

References (33)

1. International Diabetes Federation. IDF Diabetes Atlas, 8th edition. International Diabetes Foundation, 2017
2. Livingstone SJ, Levin D, Looker HC, et al.; Scottish Diabetes Research Network epidemiology group; Scottish Renal Registry. Estimated life expectancy in a Scottish cohort with type 1 diabetes, 2008-2010. JAMA 2015;313:37-44
3. McKnight JA, Wild SH, Lamb MJ, et al. Gly-caemic control of type 1 diabetes in clinical practice early in the 21st century: an international comparison. Diabet Med 2015;32:1036-1050
4. Nathan DM, Bayless M, Cleary P, et al.; DCCT/ EDIC Research Group. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study at 30 years: advances and contributions. Diabetes 2013;62: 3976-3986
5. Miller KM, Foster NC, Beck RW, et al.; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care 2015;38:971-978
6. Weinstock RS, Schütz-Fuhrmann I, Connor CG, et al.; T1D Exchange Clinic Network; DPV Initiative. Type 1 diabetes in older adults: Comparing treatments and chronic complications in the United States T1D Exchange and the German/ Austrian DPV registries. Diabetes Res Clin Pract 2016;122:28-37
7. Petrie JR. SGLT2 inhibitors in type 1 diabetes: knocked down, but up again? Lancet Diabetes Endocrinol 2017;5:841-843
8. Akturk HK, Rewers A, Garg SK. SGLT inhibition: a possible adjunctive treatment for type 1 diabetes. Curr Opin Endocrinol Diabetes Obes 2018;25:246-250
9. Yamada T, Shojima N, Noma H, Yamauchi T, Kadowaki T. Sodium-glucose co-transporter-2 inhibitors as add-on therapy to insulin for type 1 diabetes mellitus: systematic review and meta-analysis of randomized controlled trials. Diabetes Obes Metab 2018;20:1755-1761
10. Dandona P, Mathieu C, Phillip M, et al.; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol 2017;5:864-876
11. Garg SK, Henry RR, Banks P, et al. Effects of sotagliflozin added to insulin in patients with type 1 diabetes. N Engl J Med 2017;377:2337-2348
12. Buse JB, Garg SK, Rosenstock J, et al. Sotagli-flozin in combination with optimized insulin therapy in adults with type 1 diabetes: the North American inTandem1 study. Diabetes Care 2018;41:1970-1980
13. 1c and hypoglycemia reductions at 24 and 52 weeks with sotagliflozin in combination with insulin in adults with type 1 diabetes: the European in-Tandem2 study. Diabetes Care 2018;41:1981-1990
14. Nathan DM. Adjunctive treatments for type 1 diabetes. N Engl J Med 2017;377:2390-2391
15. Mondick J, Riggs M, Kaspers S, Soleymanlou N, Marquard J, Nock V. Population pharmaco-kinetic-pharmacodynamic analysis to characterize the effect of empagliflozin on renal glucose threshold in patients with type 1 diabetes mellitus. J Clin Pharmacol 2018;58:640-649
16. Zinman B, Wanner C, Lachin JM, et al.; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 2015;373:2117-2128
17. Cherney DZ, Perkins BA, Soleymanlou N, et al. The effect of empagliflozin on arterial stiffness and heart rate variability in subjects with uncomplicated type 1 diabetes mellitus. Cardiovasc Diabetol 2014;13:28
18. Cherney DZ, Perkins BA, Soleymanlou N, et al. Renal hemodynamic effect of sodium-glucose cotransporter 2 inhibition in patients with type 1 diabetes mellitus. Circulation 2014;129:587-597
19. Cherney DZ, Perkins BA, Soleymanlou N, et al. Sodium glucose cotransport-2 inhibition and intrarenal RAS activity in people with type 1 diabetes. Kidney Int 2014;86:1057-1058
20. Famulla S, Pieber TR, Eilbracht J, et al. Glucose exposure and variability with empagliflozin as adjunct to insulin in patients with type 1 diabetes: continuous glucose monitoring data from a 4-week, randomized, placebo-controlled trial (EASE-1). Diabetes Technol Ther 2017;19:49-60
21. Perkins BA, Cherney DZ, Partridge H, et al. Sodium-glucose cotransporter 2 inhibition and glycemic control in type 1 diabetes: results of an 8-week open-label proof-of-concept trial. Diabetes Care 2014;37:1480-1483
22. Perkins BA, Cherney DZ, Soleymanlou N, et al. Diurnal glycemic patterns during an 8-week open-label proof-of-concept trial of empagliflozin in type 1 diabetes. PLoS One 2015; 10:e0141085
23. Pieber TR, Famulla S, Eilbracht J, et al. Empagliflozin as adjunct to insulin in patients with type 1 diabetes: a 4-week, randomized, placebo-controlled trial (EASE-1). Diabetes Obes Metab 2015;17:928-935
24. Shimada A, Hanafusa T, Yasui A, et al. Empagliflozin as adjunct to insulin in Japanese participants with type 1 diabetes: results of a 4-week, double-blind, randomized, placebo-controlled phase 2 trial. Diabetes Obes Metab 2018;20:2190-2199
25. Arora S, Henderson SO, Long T, Menchine M. Diagnostic accuracy of point-of-care testing for diabetic ketoacidosis at emergency-department triage: beta-hydroxybutyrate versus the urine dipstick. Diabetes Care 2011;34:852-854
26. Weinstock RS, Xing D, Maahs DM, et al.; T1D Exchange Clinic Network. Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: results from the T1D Exchange clinic registry. J Clin Endocrinol Metab 2013;98:3411-3419
27. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industryddiabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention [Internet], February 2008. Available from https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM071624.pdf. Accessed 15 August 2018
28. Ahrén B, Hirsch IB, Pieber TR, et al.; ADJUNCT TWO Investigators. Efficacy and safety of liraglutide added to capped insulin treatment in subjects with type 1 diabetes: the ADJUNCT TWO randomized trial. Diabetes Care 2016;39:1693-1701
29. Mathieu C, Zinman B, Hemmingsson JU, et al.; ADJUNCT ONE Investigators. Efficacy and safety of liraglutide added to insulin treatment in type 1 diabetes: the ADJUNCT ONE treat-to-target randomized trial. Diabetes Care 2016; 39:1702-1710
30. Younk LM, Mikeladze M, Davis SN. Pramlin-tide and the treatment of diabetes: a review of the data since its introduction. Expert Opin Pharmacother 2011;12:1439-1451
31. Henry RR, Rosenstock J, Edelman S, et al. Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study. Diabetes Care 2015;38:412-419
32. Aiello LP; DCCT/EDIC Research Group. Diabetic retinopathy and other ocular findings in the Diabetes Control and Complications Trial/ Epidemiology of Diabetes Interventions and Complications study. Diabetes Care 2014;37:17-23
33. Laffel LM, Wentzell K, Loughlin C, Tovar A, Moltz K, Brink S. Sick day management using blood 3-hydroxybutyrate (3-OHB) compared with urine ketone monitoring reduces hospital visits in young people with T1DM: a randomized clinical trial. Diabet Med 2006;23:278-284