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Switching to Once-Weekly Insulin Icodec Versus Once-Daily Insulin Glargine U100 in Type 2 Diabetes Inadequately Controlled on Daily Basal Insulin: A Phase 2 Randomized Controlled Trial.

AbstractOBJECTIVE:
Insulin icodec (icodec) is a novel once-weekly basal insulin analog. This trial investigated two approaches for switching to icodec versus once-daily insulin glargine 100 units/mL (IGlar U100) in people with type 2 diabetes receiving daily basal insulin and one or more oral glucose-lowering medications.
RESEARCH DESIGN AND METHODS:
This multicenter, open-label, treat-to-target phase 2 trial randomized (1:1:1) eligible basal insulin-treated (total daily dose 10-50 units) people with type 2 diabetes (HbA1c 7.0-10.0% [53.0-85.8 mmol/mol]) to icodec with an initial 100% loading dose (in which only the first dose was doubled [icodec LD]), icodec with no loading dose (icodec NLD), or IGlar U100 for 16 weeks. Primary end point was percent time in range (TIR; 3.9-10.0 mmol/L [70-180 mg/dL]) during weeks 15 and 16, measured using continuous glucose monitoring. Key secondary end points included HbA1c, adverse events (AEs), and hypoglycemia.
RESULTS:
Estimated mean TIR during weeks 15 and 16 was 72.9% (icodec LD; n = 54), 66.0% (icodec NLD; n = 50), and 65.0% (IGlar U100; n = 50), with a statistically significant difference favoring icodec LD versus IGlar U100 (7.9%-points [95% CI 1.8-13.9]). Mean HbA1c reduced from 7.9% (62.8 mmol/mol) at baseline to 7.1% (54.4 mmol/mol icodec LD) and 7.4% (57.6 mmol/mol icodec NLD and IGlar U100); incidences and rates of AEs and hypoglycemic episodes were comparable.
CONCLUSIONS:
Switching from daily basal insulin to once-weekly icodec was well tolerated and provided effective glycemic control. Loading dose use when switching to once-weekly icodec significantly increased percent TIR during weeks 15 and 16 versus once-daily IGlar U100, without increasing hypoglycemia risk.
AuthorsHarpreet S Bajaj, Richard M Bergenstal, Andreas Christoffersen, Melanie J Davies, Amoolya Gowda, Joakim Isendahl, Ildiko Lingvay, Peter A Senior, Robert J Silver, Roberto Trevisan, Julio Rosenstock
JournalDiabetes care (Diabetes Care) Vol. 44 Issue 7 Pg. 1586-1594 (07 2021) ISSN: 1935-5548 [Electronic] United States
PMID33875485 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
Copyright© 2021 by the American Diabetes Association.
Chemical References
  • Blood Glucose
  • Glycated Hemoglobin A
  • Hypoglycemic Agents
  • Insulin, Long-Acting
  • insulin icodec
  • Insulin Glargine
Topics
  • Blood Glucose
  • Blood Glucose Self-Monitoring
  • Diabetes Mellitus, Type 2 (drug therapy)
  • Glycated Hemoglobin (analysis)
  • Humans
  • Hypoglycemic Agents (adverse effects)
  • Insulin Glargine (adverse effects)
  • Insulin, Long-Acting

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