This study investigated the safety and efficacy of IDegLira as add-on to SGLT2i. In this 26-week, phase 3b, open-label trial, 420 patients with T2D uncontrolled on SGLT2i ± OADs were randomized 1:1 to receive add-on therapy of IDegLira or IGlar U100 (100 units [U]/mL). Starting doses were 10 U in both treatment arms. Doses were titrated twice-weekly to a fasting glucose target of 72 to 90 mg/dL; only IDegLira had a maximum dose (50 U).

Mean A1C decreased from 8.2% at baseline to 6.3% at week 26 for IDegLira and from 8.4 to 6.7% for IGlar U100; IDegLira superiority confirmed (p<0.0001). IDegLira treatment resulted in unchanged mean body weight vs. 2.0 kg weight gain with IGlar U100 (p<0.0001). The rate of treatment emergent severe or blood glucose confirmed symptomatic hypoglycemic episodes was 58% lower (p=0.0035) with IDegLira (0.37 events/patient-year of exposure [PYE]) vs. IGlar U100 (0.90 events/PYE). Total daily insulin dose after 26 weeks was 36 U for IDegLira vs. 54 U for IGlar U100 (p<0.0001). Adverse event rates were low in both treatment arms with no unexpected safety issues.

In conclusion, superiority of IDegLira vs. IGlar U100 as add-on to SGLT2i was confirmed for glycemic control, body weight, hypoglycemia rate and total daily insulin dose.
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A. Philis-Tsimikas: Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S, Sanofi, Mylan. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Esperion Therapeutics, Ionis Pharmaceuticals, Inc.. Advisory Panel; Self; AstraZeneca. L. Billings: Advisory Panel; Self; Novo Nordisk A/S, Sanofi. Consultant; Self; Novo Nordisk A/S. Research Support; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S, Dexcom, Inc. R.S. Busch: Speaker's Bureau; Self; AbbVie Inc., AstraZeneca. Research Support; Self; Bayer AG, Intarcia Therapeutics, Inc.. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Amgen Inc.. Research Support; Self; Sanofi US. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Amarin Corporation. C. Morales Portillo: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Abbott. Research Support; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Theracos, Inc., Lexicon Pharmaceuticals, Inc.. Speaker's Bureau; Self; Novo Nordisk A/S, Sanofi, Eli Lilly and Company, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Janssen Pharmaceuticals, Inc., AstraZeneca, Abbott. R. Sahay: Advisory Panel; Self; Boehringer Ingelheim, Sanofi, Eli Lilly and Company, Novo Nordisk A/S. Advisory Panel; Spouse/Partner; Intas Pharmaceuticals Ltd., Pfizer Inc.. Speaker's Bureau; Self; Sanofi, Eli Lilly and Company, Boehringer Ingelheim, Dr. Reddys Laboratories, USV Private Limited, Glenmark. Speaker's Bureau; Spouse/Partner; Boehringer Ingelheim. N. Halladin: Employee; Self; Novo Nordisk A/S. R. Juhl: Employee; Self; Novo Nordisk A/S. S. Harris: Advisory Panel; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Amgen Inc., Lilly/Boehringer Ingelheim, Abbott, Janssen. Consultant; Self; Novo Nordisk A/S, Sanofi, Merck, AstraZeneca, Lilly/Boehringer Ingelheim, Abbott, Janssen. Research Support; Self; Novo Nordisk A/S, Sanofi, Merck, Abbott, AstraZeneca, Janssen. Other Relationship; Self; CIHR, CDA, The Lawson Foundation.

© 2018 by the American Diabetes Association.
2018
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