Abstract | OBJECTIVE: 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.
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Authors | Harpreet 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 |
Journal | Diabetes care
(Diabetes Care)
Vol. 44
Issue 7
Pg. 1586-1594
(07 2021)
ISSN: 1935-5548 [Electronic] United States |
PMID | 33875485
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © 2021 by the American Diabetes Association. |
Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin, Long-Acting
- insulin icodec
- Insulin Glargine
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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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