Sotagliflozin added to optimized insulin therapy leads to HbA1c reduction without weight gain in adults with type 1 diabetes: A pooled analysis of inTandem1 and inTandem2

Diabetes, Obesity and Metabolism

Volumn 22, Issue 11, 2020, Pages 2089-2096

  Rodbard, Helena W ^a   Giaccari, Andrea ^b   Lajara, Rosemarie ^c   Stewart, John ^d   Strumph, Paul S ^e,g   Oliveira, Juliana ^f,h   Lapuerta, Pablo ^e   Castro, Rita ^f  

^a Endocrine and Metabolic Consultants   (United States)

^b FONDAZIONE POLICLINICO UNIVERSITARIO A GEMELLI IRCCS   (Italy)

^c Diabetes America   (United States)

^d Sanofi   (Canada)

^e LEXICON PHARMACEUTICALS INC   (United States)

^f SANOFI   (France)

^g Metavant Sciences   (United States)

^h Viking Therapeutics   (United States)

Author keywords

HbA1c, insulin, personalized medicine, sotagliflozin, type 1 diabetes, weight reduction

Indexed keywords

HEMOGLOBIN A1C; INSULIN; PLACEBO; SOTAGLIFLOZIN; (2S,3R,4R,5S,6R)-2-(4-CHLORO-3-(4-ETHOXYBENZYL)PHENYL)-6-(METHYLTHIO)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; ANTIDIABETIC AGENT; GLYCOSIDE; GLYCOSYLATED HEMOGLOBIN;

ADULT; ARTICLE; BODY WEIGHT GAIN; CONTROLLED STUDY; DIABETIC KETOACIDOSIS; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DRUG EFFICACY; DRUG SAFETY; DUAL ENERGY X RAY ABSORPTIOMETRY; ENERGY METABOLISM; ENVIRONMENTAL FACTOR; FATTY ACID METABOLISM; FUNGAL GENITAL INFECTION; GLUCOSE INTAKE; GLYCEMIC CONTROL; GLYCOLYSIS; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; LIPOLYSIS; MAJOR CLINICAL STUDY; OUTCOME ASSESSMENT; PREVALENCE; PROCESS OPTIMIZATION; SYSTOLIC BLOOD PRESSURE; URINARY TRACT INFECTION; COMBINATION DRUG THERAPY; DOUBLE BLIND PROCEDURE; META ANALYSIS;

ADULT; DIABETES MELLITUS, TYPE 1; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; GLYCATED HEMOGLOBIN A; GLYCOSIDES; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; WEIGHT GAIN;

EID: 85088599184     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.14127     Document Type: Article

References (30)

1. Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D exchange clinic registry. Diabetes Care. 2015;38(6):971-978.
2. The Diabetes Control Complications Trial Research Group, Nathan DM, Genuth S, et al. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329(14):977-986.
3. Bode BW, Garg SK. The emerging role of adjunctive noninsulin antihyperglycemic therapy in the management of type 1 diabetes. Endocr Pract. 2016;22(2):220-230.
4. Chillaron JJ, Flores Le-Roux JA, Benaiges D, Pedro-Botet J. Type 1 diabetes, metabolic syndrome and cardiovascular risk. Metabolism. 2014;63(2):181-187.
5. Weinstock RS, Schutz-Fuhrmann I, Connor CG, et al. 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.
6. Dobbins RL, Greenway FL, Chen L, et al. Selective sodium-dependent glucose transporter 1 inhibitors block glucose absorption and impair glucose-dependent insulinotropic peptide release. Am J Physiol Gastrointest Liver Physiol. 2015;308(11):G946-G954.
7. Mudaliar S, Polidori D, Zambrowicz B, Henry RR. Sodium-glucose cotransporter inhibitors: effects on renal and intestinal glucose transport: from bench to bedside. Diabetes Care. 2015;38(12):2344-2353.
8. Buse JB, Garg SK, Rosenstock J, et al. Sotagliflozin in combination with optimized insulin therapy in adults with type 1 diabetes: the north American inTandem1 study. Diabetes Care. 2018;41(9):1970-1980.
9. Danne T, Cariou B, Banks P, et al. HbA1c and hypoglycemia reduction at 24 and 52 weeks with sotagliflozin in combination with insulin in adults with type 1 diabetes: the European inTandem2 study. Diabetes Care. 2018;41(9):1981-1990.
10. Sands AT, Zambrowicz BP, Rosenstock J, et al. Sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct therapy to insulin in type 1 diabetes. Diabetes Care. 2015;38(7):1181-1188.
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(24):2337-2348.
12. Bode B, Banks P, Sawhney S, Strumph P. Efficacy and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, as adjunct to insulin in young adults with poorly controlled type 1 diabetes (JDRF study; NCT02383940). Pediatr Diabetes. 2017;18(S25):25-26.
13. Baker C, Wason S, Banks P, et al. Dose-dependent glycometabolic effects of sotagliflozin on type 1 diabetes over 12 weeks: the inTandem4 trial. Diabetes Obes Metab. 2019;21(11):2440-2449.
14. Flegal KM, Carroll MD, Kuczmarski RJ, Johnson CL. Overweight and obesity in the United States: prevalence and trends, 1960-1994. Int J Obes Relat Metab Disord. 1998;22(1):39-47.
15. Foster NC, Beck RW, Miller KM, et al. State of type 1 diabetes management and outcomes from the T1D exchange in 2016-2018. Diabetes Technol Ther. 2019;21(2):66-72.
16. El Masri D, Ghosh S, Jaber LA. Safety and efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes: a systematic review and meta-analysis. Diabetes Res Clin Pract. 2018;137:83-92.
17. Pettus JH, Weinzimer SA, McCrimmon RJ, et al. Sotagliflozin in combination with optimized insulin therapy reduced HbA1c levels with a decreased daily insulin requirement after 52 weeks in adults with T1D. Diabetes. 2018;67:5-LB.
18. Ferrannini E, Baldi S, Frascerra S, et al. Shift to fatty substrate utilization in response to sodium-glucose cotransporter 2 inhibition in subjects without diabetes and patients with type 2 diabetes. Diabetes. 2016;65(5):1190-1195.
19. Santos-Gallego CG, Requena-Ibanez JA, San Antonio R, et al. Empagliflozin ameliorates adverse left ventricular remodeling in nondiabetic heart failure by enhancing myocardial energetics. J Am Coll Cardiol. 2019;73(15):1931-1944.
20. Song P, Onishi A, Koepsell H, Vallon V. Sodium glucose cotransporter SGLT1 as a therapeutic target in diabetes mellitus. Expert Opin Ther Targets. 2016;20(9):1109-1125.
21. Seidelmann SB, Feofanova E, Yu B, et al. Genetic variants in SGLT1, glucose tolerance, and cardiometabolic risk. J Am Coll Cardiol. 2018;72(15):1763-1773.
22. Wright EM, Loo DD, Hirayama BA. Biology of human sodium glucose transporters. Physiol Rev. 2011;91(2):733-794.
23. Mathieu C, Dandona P, Gillard P, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 study): 24-week results from a randomized controlled trial. Diabetes Care. 2018;41(9):1938-1946.
24. Dandona P, Mathieu C, Phillip M, et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes: the DEPICT-1 52-week study. Diabetes Care. 2018;41(12):2552-2559.
25. Rosenstock J, Marquard J, Laffel LM, et al. Empagliflozin as adjunctive to insulin therapy in type 1 diabetes: the EASE trials. Diabetes Care. 2018;41(12):2560-2569.
26. National Institute for Health and Care Excellence. Sotagliflozin with insulin for treating type 1 diabetes. 2020. https://www.nice.org.uk/guidance/ta622/chapter/1-Recommendations [accessed March 10, 2020].
27. National Institute for Health and Care Excellence. Dapagliflozin with insulin for treating type 1 diabetes. 2020. https://www.nice.org.uk/guidance/ta597/chapter/1-Recommendations [accessed March 10, 2020].
28. European Medicines Agency. Zynquista (sotagliflozin). 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/zynquista [accessed March 10, 2020].
29. European Medicines Agency. Forxiga (dapagliflozin). 2020. https://www.ema.europa.eu/en/medicines/human/EPAR/forxiga [accessed March 10, 2020].
30. Danne T, Garg S, Peters AL, et al. International consensus on risk management of diabetic ketoacidosis in patients with type 1 diabetes treated with sodium-glucose cotransporter (SGLT) inhibitors. Diabetes Care. 2019;42(6):1147-1154.