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Long-acting insulin degludec improved glucose control when injected three times a week

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New ultra-long-acting insulin degludec injected three times a week provided comparable glycemic control to once-daily insulin degludec and insulin glargine, without additional hypoglycemia, a new study found.

Bernard Zinman, MD, and researchers said insulin degludec has the potential to reduce dosing frequency due to its ultra-long action profile.

Currently in development, insulin degludec (DegludecPlus, Novo Nordisk) is a novel basal insulin that forms soluble multihexamer assemblies following subcutaneous injection, which results in an ultra-long action profile that is still detectable after 96 hours of injection.

Comparable glycemic control

The researchers conducted a 16-week, randomized, open-label, parallel-group, phase 2 trial that examined the safety and efficacy of once-daily and three-times-weekly insulin degludec compared with once-daily insulin degludec (Lantus, Sanofi-Aventis) in insulin-naïve patients with inadequately controlled type 2 diabetes. All participants were aged 18 to 75 years, had a baseline HbA1c of 7% to 11% and were treated at 28 clinical sites in the United States, Canada, India and South Africa.

In combination with metformin, 245 patients were randomly assigned to:

• Insulin degludec three times weekly at a starting dose of 20 U per injection (n=62)
• Insulin degludec (600 nmol/mL formulation) once a day at a starting dose of 10 U (n=60)
• Insulin degludec (900 nmol/mL formulation) once a day at a starting dose of 10 U (n=61)
• Insulin glargine once a day at a starting dose of 10 U (n=62)

At 16 weeks, HbA1c levels were the same across treatment groups, ranging from 7.2% to 7.5%. Compared with insulin glargine, the estimated mean HbA1c treatment difference with insulin degludec three times a week was 0.08% and ranged from 0.17% to 0.28% for the once a day formulations.

Overall, the number of adverse events across the groups was similar, and no apparent treatment-specific pattern emerged. Reports of hypoglycemia, defined as 55.8 mg/dL or lower, were uncommon. Hypoglycemia occurred in 23% of the three-times-weekly insulin degludec and insulin glargine groups, and in 8% to 15% of the once-a-day insulin degludec groups. Nocturnal hypoglycemia was reported in 0% to 5% of the groups.

“This new basal insulin analogue might be a valuable addition to clinical practice,” Zinman said in a press release. “However, the safety, efficacy and optimum use of treatment regimens for insulin degludec will need to be established in larger phase 3 trials.”

Lifestyle and a longer dosing schedule

The researchers concluded that “a three-times-a-week, weekend off, dosing regimen might appeal to some people with type 2 diabetes who are inadequately controlled on oral antidiabetic drug treatments, potentially helping with acceptance and early initiation of insulin therapy.”

Yogish C. Kudva, MBBS, and Ananda Basu, MBBS, both from the Mayo Clinic in Rochester, Minn., wrote in an accompanying editorial that the ultra-long action may also improve adherence and cause less disruption to a patient’s lifestyle.

“In this age of multitasking, which imposes an additional burden on human memory, dosing interval is especially important. …It is extremely worthwhile to remember that therapeutic lifestyle changes are inexpensive and favorable on a risk-benefit basis and need persistent reemphasis, as is being done for the financial benefits accruing to patients from their employer and insurance by doing so,” Kudva and Basu wrote.

The aforementioned results are similar to phase 2 data presented by Zinman at the American Diabetes Association 70^th Scientific Sessions in June 2010. Further, recently published phase 3 results of a study that compared insulin degludec with insulin glargine also showed comparable glycemic control without differing rates of hypoglycemia.

For more information:

• Kudva YC. Lancet. 2011;doi:10.1016/S0140-6736(11)60097-4.
• Zinman B. Lancet. 2011;doi:10.1016/S0140-6736(10)62305-7.

Disclosure: The study was funded by Novo Nordisk. Dr. Zinman has received fees for consultancy and honoraria for membership of advisory boards from Novo Nordisk, GlaxoSmithKline, Merck, Eli Lilly, Amylin and Boehringer Ingelheim and grant support from Novo Nordisk, GlaxoSmithKline and Merck. He has also received travel/accommodation expenses and expense coverage from Novo Nordisk to attend investigator and scientific meetings. Drs. Kudva and Basu report no relevant financial disclosures.

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