Phase 2 Trials Demonstrate Efficacy and Tolerability of Once-Weekly Insulin Icodec in Type 2 Diabetes
Novo Nordisk
Insulin Developer and Manufacturer
BAGSVÆRD, Denmark, Sept. 24, 2020 /PRNewswire/ -- Today, Novo Nordisk announced the results of three Phase 2 clinical trials of insulin icodec, an investigational once-weekly basal insulin analogue. The results were presented at the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD) in 2020.
The first study demonstrated that, compared with once-daily insulin glargine U100, switching from other basal insulins to insulin icodec using two different conversion methods was effective and well tolerated, without increasing the risk of clinically significant or severe hypoglycemia.1A total of 154 adult patients with type 2 diabetes inadequately controlled with oral antidiabetic drugs participated in this 16-week Phase 2 clinical trial. Patients were randomly switched from once- or twice-daily basal insulin injections to either once-weekly insulin icodec (with or without a loading dose regimen) or insulin glargine U100.1,2The primary endpoint of this trial was the time in range (TIR) for blood glucose levels of 3.9–10.0 mmol/L at Weeks 15 and 16, which demonstrated that patients receiving icodec insulin with a loading dose regimen had a significantly higher proportion of TIR compared to those using insulin glargine U100 (73% vs. 65%, respectively). In contrast, the proportion of TIR for patients receiving icodec insulin without a loading dose regimen was similar to that of insulin glargine U100 (66% vs. 65%, respectively).1
Dr. Harpreet Bajaj, Chief Investigator and Endocrinology Specialist at the LMC Diabetes and Endocrinology Centre in Ontario, Canada, stated, “We know that many patients with type 2 diabetes prefer simpler treatment regimens—specifically, those requiring fewer injections and offering greater convenience compared to current once- or twice-daily basal insulin therapies.” “This Phase 2 clinical trial demonstrates that icodec can provide potential benefits for patients with type 2 diabetes who require insulin therapy, helping them transition easily to a new treatment regimen, move away from the cumbersome and complex daily routines of current therapies, and even achieve longer periods of glycemic control with a reduced risk of hypoglycemia.”
Important secondary endpoints include those related to HbA1cThe differences from baseline compared with insulin glargine U100 were not statistically significant for insulin icodec administered with or without a loading dose (–0.54%, –0.77, and –0.47 percentage points, respectively). The incidence of clinically significant or severe hypoglycemia was similar between insulin icodec with a loading dose and insulin glargine U100 (exposure-adjusted rates of level 2 [<3 mmol/L] and level 3 [severe] hypoglycemic events were 0.78 and 0.79 events per patient-year of exposure, respectively, in patients receiving insulin icodec and insulin glargine U100), whereas the rate was lower in patients receiving insulin icodec without a loading dose (0.15 events per patient-year of exposure). No new safety concerns were identified with once-weekly insulin icodec, and no severe episodes occurred during the trial.1
The conference also presented comparative data on the efficacy of different titration algorithms for icodec insulin versus those for insulin glargine U100, to better understand the optimal titration dosing of once-weekly basal insulin in patients with type 2 diabetes inadequately controlled by oral antidiabetic drugs. In this 16-week trial, all three once-weekly icodec insulin titration algorithms demonstrated good tolerability and efficacy, achieving a time to target that was either superior or similar to that of once-daily insulin glargine U100, depending on the titration algorithm applied.3,4
At the EASD Annual Meeting, results from a 26-week Phase 2 clinical trial of insulin icodec in insulin-naïve adults with type 2 diabetes were also reported, demonstrating glycemic efficacy and safety profiles similar to those of once-daily insulin glargine U100; the trial results were simultaneously published in《New EngThe LancetOn.5,6These data were previously presented at the 80th Scientific Sessions of the American Diabetes Association in June 2020.7。
Mads Krogsgaard Thomsen, Executive Vice President and Chief Scientific Officer at Novo Nordisk, stated, “As a leader in diabetes innovation, Novo Nordisk fully recognizes the necessity of continuously innovating treatment solutions to help patients with diabetes and improve therapeutic outcomes.” “We are highly encouraged by the Phase 2 trial data on insulin icodec presented at the EASD 2020 and ADA 2020 annual meetings, which demonstrated efficacy and good tolerability, and may offer a simpler treatment regimen for patients with type 2 diabetes who are initiating or switching to insulin therapy.”
The Phase 2 trial will lay the foundation for the design of Phase 3 clinical development trials evaluating once-weekly insulin icodec therapy, which Novo Nordisk plans to initiate in late 2020.
For more informationNovo NordiskNovo Nordisk participationEASD 2020More Thoughts on the Annual MeetingFor news and media materials, please visit: https://www.epresspack.net/novonordiskEASD2020/phase-2-once-weekly-insulin
About2Scheduled ResectionSwitching Trial
This 16-week, randomized, open-label Phase 2 clinical trial of targeted therapy enrolled 154 patients with inadequate glycemic control (HbA1c7.0–10.0%) in patients with type 2 diabetes, comparing the efficacy and safety of once-weekly insulin icodec therapy administered with and without a loading dose versus once-daily insulin glargine U100*. Using insulin glargine U100 as the comparator, the study evaluated unit-to-unit conversion with and without an initial 100% loading dose of insulin icodec (or a 20% dose reduction for patients who had been receiving twice-daily basal insulin or insulin glargine U300 prior to randomization). Insulin doses were titrated weekly to a target range of 4.4–7.2 mmol/L based on the lowest value (if below target) or the average of three self-measured pre-breakfast blood glucose values. The primary endpoint was assessed at Weeks 15 and 19 using continuous glucose monitoring (Dexcom G6®, Dexcom Inc., California, USA) with a target range of 3.9–10.0 mmol/L (70–180 mg/dL). Secondary endpoints included HbA1cand the difference in body weight from baseline persisted through Week 16, weekly insulin doses during Weeks 15 and 16, and hypoglycemia.1,2
AbouticodecPancreasInsulin
Icodec insulin is an investigational long-acting basal insulin analog with a half-life of approximately one week.8Following injection, icodec binds firmly and reversibly to albumin. This enables sustained, slow, and stable release of the therapeutic agent, effectively lowering blood glucose levels throughout the week. Due to its concentrated formulation, the once-weekly dose of icodec is equivalent to the daily dose of insulin glargine U100.9
AboutNovo Nordisk
Novo Nordisk is a global healthcare leader founded in 1923 and headquartered in Denmark. Our vision is to defeat diabetes and other serious chronic diseases, such as obesity, rare blood disorders, and endocrine disorders, through continuous innovation. We achieve this vision through scientific breakthroughs, expanding access to our medicines, and integrating prevention with treatment. Novo Nordisk employs approximately 43,500 people across 80 countries, and its products are sold in 170 countries. For more information, please visitnovonordisk.com、Facebook、Twitter、LinkedIn、YouTube。
More Information
Media:
Mette Kruse Danielsen
+45 3079 3883
Investors:
Daniel Muusmann Bohsen
+45 3075 2175
Valdemar Borum Svarrer
+45 3079 0301
Ann Søndermølle Rendbæk
+45 3075 2253
Mark Joseph Root
+45 3079 4211
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*NCT03922750: A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
References
1. Bajaj HS, Isendahl J, Gowda A, et alEfficacy and Safety of Switching to Insulin Icodec, a Once-Weekly Basal Insulin, vs Insulin Glargine U100 in Patients with T2D Inadequately Controlled on OADs and Basal Insulin. Abstract 657. Presented at the symposium “The impact of new basal insulins” during the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD), September 22, 2020, 12:00–13:00 CEST.
2. ClinicalTrials.gov. A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine. Article link:https://clinicaltrials.gov/ct2/show/NCT03922750. Last read: September 2020.
3. Lingvay I, Koefoed MM, Stachlewska K, et al. Effect of Three Different Titration Algorithms of Insulin Icodec vs. Insulin Glargine U100 on Time in Range in Patients with T2D Inadequately Controlled on OADs. Abstract 658. Presented at the symposium “The impact of new basal insulins” during the 56th European Association for the Study of Diabetes (EASD) Annual Meeting, held online in 2020, on September 22, 2020, 12:00–13:00 CEST.
4. ClinicalTrials.gov. A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before. Article link:https://clinicaltrials.gov/ct2/show/NCT03951805. Last read: September 2020
5. Rosenstock J, Kjærsgaard MIS, Møller DV, et al.Once-Weekly Basal Insulin Icodec Offers Comparable Efficacy and Safety vs Once-Daily Insulin Glargine U100 in Insulin Naïve Patients with T2D Inadequately Controlled on OADs. Abstract 56. Presented at the “Developing better insulins” session of the 56th European Association for the Study of Diabetes (EASD) Annual Meeting 2020, held online, September 22, 2020, 14:45–15:00 CEST.
6. Rosenstock J, Bajaj HS, Janez A, et al. Once-Weekly Insulin for Type 2 Diabetes Without Previous Insulin Treatment. New England Journal of Medicine. 2020; preprint; DOI: 10.1056/NEJMoa2022474. Article link:https://www.nejm.org/doi/full/10.1056/NEJMoa2022474。
7. Rosenstock J, Kjærsgaard MIS, Møller DV, et alOnce-Weekly Basal Insulin Icodec Offers Comparable Efficacy and Safety vs Once-Daily Insulin Glargine U100 in Insulin Naïve Patients with T2D Inadequately Controlled on OADs. Abstract 238-OR. Presented at the “Insulin Therapies” session of the American Diabetes Association’s 80th Scientific Sessions, held online, June 14, 2020, 18:15–18:30 Central Time (US).
8. Hövelmann U, Brøndsted L, Kristensen NR. et al. Insulin Icodec: An Insulin Analog Suited for Once-Weekly Dosing in Type 2 Diabetes. Abstract 237-OR. Presented at the “Insulin Therapies” session of the 80th Scientific Sessions of the American Diabetes Association, June 14, 2020, 18:00–18:15 Central Time (US).
9. Nishimura E, Kjeldsen T, Hubálek F, et al. Molecular and Biological Properties of Insulin Icodec, a New Insulin Analog Designed to Give a Long Half-Life Suitable for Once-Weekly Dosing. Presented in the “Insulin Therapies” session at the 80th Scientific Sessions of the American Diabetes Association, June 14, 2020, 17:45–18:00 Central Time (US).