The new long-term *** has a low risk of hypoglycemia

Several studies reported at the annual meeting of the American Diabetes Association (ADA) have shown that research-based ultra-long-acting insulin degludec improves insulin control and has a low risk of hypoglycemia. Many of these patients are obese and require larger doses of insulin.

Derdogol (IDeg), produced by Novo Nordisk, is a basal insulin that forms soluble polyhexamers after subcutaneous injection, making its half-life significantly longer than 24 h. Endocrinologist Helena W of Maryland. Dr. Rodbard pointed out that due to the stability of the blood insulin concentration produced, the risk of hypoglycemia in patients with type 1 and type 2 diabetes using Degu insulin was significantly lower than those who used insulin glargine. The U.S. Food and Drug Administration (FDA) is currently considering whether to approve the drug.

Richard M, Executive Director, International Diabetes Center, Minneapolis. Dr. Bergenstal pointed out that about one-third of people with type 2 diabetes in the United States need more than 60 U of basal insulin daily, and many even require 80 or 100 U. This situation promoted the development of new basal insulin to meet the requirements of longer-term and more stable.

The meta-analysis reported by Dr. Rodbard involved five Phase IIIA, open, randomized, treatment-compliant, confirmatory, 26- to 52-week trials with 2,262 patients undergoing insulin treatment and 1,110 patients receiving insulin glargine. Treatment of patients with type 2 diabetes were given once daily. As of the end of the trial, 35% and 34% of the patients in the insulin and insulin glargine groups, respectively, required daily use of more than 60 U of basal insulin.

At the end of the study, the glycosylated hemoglobin A1c values ​​were similar between the two groups, with an estimated treatment difference (ETD) of only 0.05% (P=0.44). The mean fasting plasma glucose was lower in the insulin-deficient group, with an ETD of –5.9 mg/dl. Among patients who required more than 60 U basal insulin per day, patients in the insulin-detergent group confirmed that the overall hypoglycaemia and nocturnal hypoglycemia rates were lower than those in the insulin glargine group. Confirmation of overall hypoglycemia was defined as self-tested blood glucose lower than 56 mg/dl (plasma calibration) or episodes requiring intervention, confirming that nocturnal hypoglycemia was defined as any confirmed episode occurring between midnight and 6 am.

Compared with the insulin glargine group, the Degu insulin group confirmed that the overall incidence of hypoglycemia was reduced by 21% (P=0.02), confirming that the incidence of nocturnal hypoglycemia was reduced by 52% (P<0.0001).

At the same time, Novo Nordisk is developing a 200 U/ml insulin solution for patients with high insulin demand. This dosage form is called IDeg U200, and 100 U/ml dosage forms contain the same amount of insulin, and the amount of liquid is only half of the latter, so that the patient can obtain a larger dose of insulin through a single injection (up to 160 U).

Dr. Bergenstal reported the results of a 26-week open, therapeutic compliance trial comparing the efficacy and safety of IDeg U200 and 100 U/ml insulin glargine once a day, both with oral hypoglycemic drugs. Joint use. The trial included 457 patients with newly diagnosed insulin type 2 diabetes who were all eligible for insulin therapy. These patients were randomized and given either IDeg U200 or insulin glargine, all in combination with metformin, and some patients also used other drugs.

As of week 26, IDeg U200 reduced HbA1c by 1.30% (8.3% at baseline), not worse than insulin glargine, with an ETD of 0.04%. The fasting blood glucose levels in both groups were similarly reduced. The IDeg U200 group confirmed that the overall incidence of hypoglycemia (defined as <56 mg/dl, or episodes requiring intervention) was lower with 1.22 events/patient-year compared with 1.42 events/patient in the insulin glargine- year. The IDeg U200 group confirmed that the incidence of nocturnal hypoglycemia was also lower (0.18 vs. 0.28 events/patient-year). No severe hypoglycemia occurred in either group.

After 26 weeks, the average daily insulin dose was similar between the two groups (IDeg U200 vs. Glargine: 0.62 U/kg vs. 0.66 U/kg). While HbA1c decreased, both groups experienced weight gain, with an average increase of 1.9 kg and 1.5 kg, respectively. Adverse events were similar and rare in both groups.

All the above studies were funded by Novo Nordisk.