Correction: Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial (The Lancet Diabetes & Endocrinology (2018) 6(5) (370–381) (S2213858718300238) (10.1016/S2213-8587(18)30023-8));Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial

The Lancet Diabetes and Endocrinology

Volumn 6, Issue 5, 2018, Pages 370-381

  Ludvik, Bernhard ^a   Frías, Juan P ^b   Tinahones, Francisco J ^c   Wainstein, Julio ^d   Jiang, Honghua ^e   Robertson, Kenneth E ^e   García Pérez, Luis Emilio ^e   Woodward, D Bradley ^e   Milicevic, Zvonko ^e  

^a KRANKENANSTALT RUDOLFSTIFTUNG   (Austria)

^b NATIONAL RESEARCH INSTITUTE   (United States)

^c HOSPITAL UNIVERSITARIO VIRGEN DE LA VICTORIA   (Spain)

^d TEL AVIV UNIVERSITY   (Israel)

^e ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DAPAGLIFLOZIN; DULAGLUTIDE; EMPAGLIFLOZIN; GLUCOSE; HEMOGLOBIN A1C; METFORMIN; PLACEBO; SODIUM GLUCOSE COTRANSPORTER 2 INHIBITOR; ANTIDIABETIC AGENT; FUSION PROTEIN; GLUCAGON LIKE PEPTIDE; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; IMMUNOGLOBULIN FC FRAGMENT;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADD ON THERAPY; ARTICLE; BACKACHE; BODY MASS; BODY WEIGHT CHANGE; BODY WEIGHT LOSS; CONTROLLED STUDY; DIABETIC KETOACIDOSIS; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FRACTURE; GENITAL TRACT INFECTION; GLUCOSE BLOOD LEVEL; HEADACHE; HUMAN; HYPOTENSION; INCIDENCE; INJECTION SITE HYPERSENSITIVITY; INJECTION SITE REACTION; LOW DRUG DOSE; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; TREATMENT RESPONSE; URTICARIA; UTERUS CARCINOMA; VOMITING; ANALOGS AND DERIVATIVES; BLOOD; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DOUBLE BLIND PROCEDURE; FEMALE; MALE; MIDDLE AGED; TREATMENT OUTCOME;

DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; GLUCAGON-LIKE PEPTIDES; GLYCATED HEMOGLOBIN A; HUMANS; HYPOGLYCEMIC AGENTS; IMMUNOGLOBULIN FC FRAGMENTS; MALE; MIDDLE AGED; RECOMBINANT FUSION PROTEINS; SODIUM-GLUCOSE TRANSPORTER 2 INHIBITORS; TREATMENT OUTCOME;

EID: 85042458412     PISSN: 22138587     EISSN: 22138595     Source Type: Journal    
DOI: 10.1016/S2213-8587(18)30152-9     Document Type: Erratum

References (37)

1. American Diabetes Association. Standards of medical care in diabetes—2017. Summary of revisions. Diabetes Care 40:suppl 1 (2017), S4–S5.
2. Marso, SP, Daniels, GH, Brown-Frandsen, K, et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med 375 (2016), 311–322.
3. Zinman, B, Wanner, C, Lachin, JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med 373 (2015), 2117–2128.
4. Neal, B, Perkovic, V, Mahaffey, KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med 377 (2017), 644–657.
5. Blonde, L, Jendle, J, Gross, J, et al. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet 385 (2015), 2057–2066.
6. Dungan, KM, Povedano, ST, Forst, T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet 384 (2014), 1349–1357.
7. Giorgino, F, Benroubi, M, Sun, JH, Zimmermann, AG, Pechtner, V, Efficacy and safety of once-weekly dulaglutide versus insulin glargine in patients with type 2 diabetes on metformin and glimepiride (AWARD-2). Diabetes Care 38 (2015), 2241–2249.
8. Meier, JJ, GLP-1 receptor agonists for individualized treatment of type 2 diabetes mellitus. Nat Rev Endocrinol 8 (2012), 728–742.
9. Nauck, M, Weinstock, RS, Umpierrez, GE, Guerci, B, Skrivanek, Z, Milicevic, Z, Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5). Diabetes Care 37 (2014), 2149–2158.
10. Pozzilli, P, Norwood, P, Jodar, E, et al. Placebo-controlled, randomized trial of the addition of once-weekly glucagon-like peptide-1 receptor agonist dulaglutide to titrated daily insulin glargine in patients with type 2 diabetes (AWARD-9). Diabetes Obes Metab 19 (2017), 1024–1031.
11. Umpierrez, G, Tofe Povedano, S, Perez Manghi, F, Shurzinske, L, Pechtner, V, Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care 37 (2014), 2168–2176.
12. Weinstock, RS, Guerci, B, Umpierrez, G, Nauck, MA, Skrivanek, Z, Milicevic, Z, Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab 17 (2015), 849–858.
13. Wysham, C, Blevins, T, Arakaki, R, et al. Efficacy and safety of dulaglutide added onto pioglitazone and metformin versus exenatide in type 2 diabetes in a randomized controlled trial (AWARD-1). Diabetes Care 37 (2014), 2159–2167.
14. Holst, JJ, Orskov, C, Nielsen, OV, Schwartz, TW, Truncated glucagon-like peptide I, an insulin-releasing hormone from the distal gut. FEBS Lett 211 (1987), 169–174.
15. Kreymann, B, Williams, G, Ghatei, MA, Bloom, SR, Glucagon-like peptide-1 7-36: a physiological incretin in man. Lancet 2 (1987), 1300–1304.
16. Inzucchi, SE, Bergenstal, RM, Buse, JB, 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 35 (2012), 1364–1379.
17. Boehringer Ingelheim Pharmaceuticals. Jardiance (empagliflozin). US package insert. http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Jardiance/jardiance.pdf, 2016 (accessed May 18, 2017).
18. Janssen Pharmaceuticals. Invokana (canagliflozin). US package insert. http://www.invokana.com/prescribing-information.pdf, 2016 (accessed May 18, 2017).
19. AstraZeneca. Farxiga (dapagliflozin). US package insert. http://www.azpicentral.com/farxiga/pi_farxiga.pdf#page=1, 2016 (accessed May 18, 2017).
20. Frías, JP, Guja, C, Hardy, E, et al. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol 4 (2016), 1004–1016.
21. Inzucchi, SE, Bergenstal, RM, Buse, JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 38 (2015), 140–149.
22. US Food and Drug Administration. FDA drug safety communication. FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function. https://www.fda.gov/drugs/drugsafety/ucm493244.htm, 2016 (accessed June 12, 2017).
23. European Medicines Agency. Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Metformin_and_metformin-containing_medicines/human_referral_000397.jsp&mid=WC0b01ac05805c516f, 2016 (accessed Oct 13, 2017).
24. Fleming, TR, Addressing missing data in clinical trials. Ann Intern Med 154 (2011), 113–117.
25. Seaquist, ER, Anderson, J, Childs, B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 36 (2013), 1384–1395.
26. Jendle, J, Grunberger, G, Blevins, T, Giorgino, F, Hietpas, RT, Botros, FT, Efficacy and safety of dulaglutide in the treatment of type 2 diabetes: a comprehensive review of the dulaglutide clinical data focusing on the AWARD phase 3 clinical trial program. Diabetes Metab Res Rev 32 (2016), 776–790.
27. Bretz, F, Posch, M, Glimm, E, Klinglmueller, F, Maurer, W, Rohmeyer, K, Graphical approaches for multiple comparison procedures using weighted Bonferroni, Simes, or parametric tests. Biom J 53 (2011), 894–913.
28. Gerstein, HC, Colhoun, HM, Dagenais, GR, et al. Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. Diabetes Obes Metab 20 (2018), 42–49.
29. Fulcher, G, Matthews, DR, Perkovic, V, et al. Efficacy and safety of canagliflozin when used in conjunction with incretin-mimetic therapy in patients with type 2 diabetes. Diabetes Obes Metab 18 (2016), 82–91.
30. Saroka, RM, Kane, MP, Busch, RS, Watsky, J, Hamilton, RA, SGLT-2 inhibitor therapy added to GLP-1 agonist therapy in the management of T2DM. Endocr Pract 21 (2015), 1315–1322.
31. Yu, M, Mody, R, Fernandez Landa, L, et al. Characteristics associated with the choice of first injectable therapy among us patients with type 2 diabetes. Clin Ther 39 (2017), 2399–2408.
32. Hansen, L, Iqbal, N, Ekholm, E, Cook, W, Hirshberg, B, Postprandial dynamics of plasma glucose, insulin, and glucagon in patients with type 2 diabetes treated with saxagliptin plus dapagliflozin add-on to metformin therapy. Endocr Pract 20 (2014), 1187–1197.
33. Defronzo, R, Martinez, R, Al-Jabori, H, Adams, J, Triplitt, C, Cersosimo, E, Liraglutide fails to offset the rise in hepatic glucose production (HGP) seen with SGLT2i treatment. June 9–13, 2017, American Diabetes Association, San Diego, CA Poster number 1075-P.
34. Novo Nordisk. Victoza (liraglutide). US package insert. http://www.novo-pi.com/victoza.pdf, 2016 (accessed May 18, 2017).
35. Sanofi-Aventis. Adlyxin (lixisenatide). US package insert. http://products.sanofi.us/adlyxin/adlyxin.pdf, 2016 (accessed Nov 19, 2017).
36. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129256.pdf, 2012 (accessed Nov 28, 2017).
37. US Food and Drug Administration. Guidance for industry—diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071624.pdf, 2008 (accessed Nov 28, 2017).