Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment
Research has shown that type 2 diabetics prefer fewer injections. Insulin icodec is developed to treat patients with diabetes. Icodec insulin has a half-life of approximately one week. The authors’ Julio Rosenstock and colleagues (2020) conducted a 26-week, randomized, double-blind, double-dummy, phase 2 trial, entitled, “Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment” published in “The New England Journal of Medicine”. The summary of the trial is given below
Objective:
To investigate the efficacy and safety of once-weekly icodec insulin in comparison to once-daily glargine U100 insulin.
Method:
A randomised, double-dummy, double-blind trial was conducted for 26 weeks. Patients who were not on insulin treatment and who have inadequately controlled diabetes despite being on metformin treatment with or without a dipeptidyl peptidase 4 inhibitors were included in this trial. Patients were divided into a 1:1 ratio. They were randomly assigned to receive once-daily subcutaneous glargine plus once-weekly placebo or once-weekly subcutaneous icodec plus once-daily placebo.
Changes in glycated haemoglobin levels were the primary outcome of the study. Hypoglycemic events, insulin affected outcomes, and safety endpoints were also assessed.
Findings:
In this 26-week trial study, results report that once-weekly subcutaneous icodec and once-daily subcutaneous glargine leads to similar glycemic control. In both the treatment, the clinical relevance of hypoglycemia (levels 2 and 3) was unaffected. Additionally, reduction in glycated haemoglobin to less than 7% in more than two-thirds of patients, reduced fasting glucose levels was observed in both groups. On the other hand, patients with once-weekly insulin icodec showed an improved 9-point patient-measured blood glucose profile than those with once-daily glargine. Favourable side effects were reported in the insulin icodec group and no unexpected safety findings were observed. Patient with icodec seems to spend an ample amount of time with tight glycemic control (70 to 140 mg/dl) than the other group with glargine. Hypoglycemic events with level 1 were higher inpatient in icodec group than glargine. No change in body weight was observed whereas there was a high mean weekly insulin dose reported in the glargine group as compare to icodec.
Limitation:
As per the authors, this study was not designed to investigate the significant differences in treatment for any endpoint. They also add that insulin adjustment was not specifically tailored for each treatment and patients with sulfonylureas treatment were excluded from the study.
Authors acknowledge future studies with larger sample sizes and diverse populations to investigate the hypoglycemic profile of icodec.
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