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Promising Data on Once-Weekly Insulin, Phase 3 Study Ongoing

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Two new phase 2 studies show encouraging findings with the investigational once-weekly basal insulin analogue icodec (Novo Nordisk) for people with type 2 diabetes who require insulin.

Insulin icodec works by reversibly binding to albumin, which slows the release of the active insulin analogue. It has a half life of about 1 week. The glucose-lowering effect is distributed nearly evenly over the course of that week.

Ildiko Lingvay, MD, of the University of Texas Southwestern Medical Center, Dallas, Texas, who is an author of both new articles, said:

“A weekly insulin is a game changer that will decrease the treatment burden for patients while also improving compliance.”

She noted that these studies demonstrate optimal approaches to initiating treatment with icodec and serve “as the steppingstones for a large phase 3 clinical trial program that is currently ongoing…which is designed to evaluate the efficacy of once-weekly insulin administration in patients with either type 1 or type 2 diabetes.”

Another advantage of the formulation, Lingvay pointed out in a press release from her institution, is that it could decrease the burden on caregivers of patients with diabetes who require insulin.

“For example, for patients who need help injecting, those living in long-term care facilities, and those with memory problems, a once-weekly insulin will facilitate treatment and decrease the burden on the care providers,” she explained.

Titration Balances Glycemic Control With Hypoglycemic Risk Reduction

The first phase 2 trial, published online April 19 in Diabetes Care, was an open-label, 16-week, treat-to-target study that involved 205 insulin-naive adults with type 2 diabetes whose A1c levels were 7% to 10% while using oral glucose-lowering medications.

They were randomly assigned to one of three once-weekly icodec titration groups:

  • Group A ― Fasting glucose target of 80–130 mg/dL with adjustments ±21 units/wk

  • Group B ― Fasting glucose target of 80–130 mg/dL with ±28 units/wk

  • Group C ― Fasting glucose target of 70–108 mg/dL, adjusting by ±28 units/wk or to once-daily glargine U100 with a fasting glucose target of 80–130 mg/dL with adjustments of ±4 units/d

The percentage of time in the ideal glucose range of 70–180 mg/dL, assessed by continuous glucose monitoring during weeks 15–16, improved from baseline levels of 57.0%, 55.2%, 51.0% for groups A, B, and C, respectively, and from 55.3% for glargine to 76.6%, 83.0%, 80.9%, and 75.9%, respectively.

There were no unexpected safety problems. Hypoglycemia episodes of glucose levels <54 mg/dL occurred in 0.05, 0.15, 0.38. and 0.00 per patient-year for the four groups, respectively. None were severe (ie, required assistance).

The titration for patients in group A (80–130 mg/dL, ±21 units/wk) yielded the best balance between glycemic control and risk for hypoglycemia, Lingvay and colleagues say.

Use of Loading Dose When Switching to Icodec Improves Time in Range

In the other phase 2 trial, also published online April 19 in Diabetes Care, Harpreet S. Bajaj, MD, of Mount Sinai Hospital, Toronto, Canada, and colleagues, with Lingvay as a co-author, examined two methods of switching to icodec. This multicenter, open-label, treat-to-target study included 154 patients with A1c levels of 7.0% to 10.0% who were already receiving basal insulin daily and at least one oral glucose-lowering medication.

Parients were randomly assigned to one of three treatment approaches: a 100% loading dose of icodec (only the first dose was doubled), no loading dose, or once-daily glargine.

The primary endpoint was time in range (70–180 mg/dL) during weeks 15 and 16. This was achieved with 72.9% of patients receiving the icodec loading dose, 66.0% of patients receiving icodec without the loading dose, and 65.0% of patients receiving daily glargine. The difference between the icodec loading dose method and glargine was significant, Bajaj and colleagues report.

The mean A1c level was reduced from an overall average of 7.9% at baseline to 7.1% in the icodec loading dose group and to 7.4% in both the no-loading dose and glargine groups.

Rates of adverse events and hypoglycemic episodes did not differ significantly among the groups.

Previous phase 2 data showing that the efficacy and safety of icodec were comparable to that of once-daily insulin glargine U100 in 247 insulin-naive patients with type 2 diabetes were published in November 2020 in The New England Journal of Medicine and were presented at the European Association for the Study of Diabetes (EASD) 2020 Annual Meeting, as reported by Medscape Medicdal News.

Both studies were funded by Novo Nordisk. Lingvey has received research funding, advisory/consulting fees, or other support from Novo Nordisk, Eli Lilly, Sanofi, AstraZeneca, Boehringer Ingelheim, Janssen, Intercept, Intarcia, Target RWE, Merck, Pfizer, Novartis, GI Dynamics, Mylan, Mannkind, Valeritas, Bayer, and Zealand Pharma. Bajaj has received speaking fees from AstraZeneca, Eli Lilly and Company, Janssen Pharmaceuticals, Merck, and Novo Nordisk and research funding paid to LMC Healthcare for serving as principal investigator on clinical trials from Amgen, AstraZeneca Boehringer Ingelheim, Ceapro Inc, Eli Lilly and Company, Gilead Sciences, Inc, Janssen Pharmaceuticals, Kowa Pharmaceuticals Co. Ltd., Madrigal Pharmaceuticals, Merck, Novo Nordisk, Sanofi, and Tricida, Inc.

Diabetes Care. Published online April 19, 2021. Lingvay et al, Abstract; Bajaj et al, Abstract

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape. Other work of hers has appeared in the Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She can be found on Twitter @MiriamETucker.

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