Healthcare company Novo Nordisk stated on Friday that its once-weekly insulin icodec showed comparable efficacy and safety to once-daily insulin glargine U100 in a randomized, double-blind, double-dummy, treat-to-target phase 2 clinical trial.
This 26-week, randomized, double-blind, double-dummy, treat-to-target phase 2 clinical trial in 247 insulin-naïve adults with type 2 diabetes controlled with metformin with or without a DPP-4i were randomized to once-weekly insulin icodec, achieving a similar blood sugar control and safety profile over adults with type 2 diabetes randomized to once-daily insulin glargine U100, revealed the company.
The company added the primary endpoint showed that the change from baseline to week 26 in blood sugar control (A1C) was similar in participants receiving once-weekly insulin icodec compared to once-daily insulin glargine U100.
Hypoglycemia, also known as a hypo or low blood sugar, was similar for both treatment groups and severe hypoglycemia were 52.5 and 45.6 events per 100 patient years of exposure for insulin icodec and insulin glargine U100 respectively.
Insulin icodec is an investigational, long-acting basal insulin analogue with a half-life of 196 hours. Once injected, insulin icodec binds strongly but reversibly to albumin. This results in a continuous, slow and steady reduction of blood sugar over the week, said the company.
In conjunction, the company plans to launch the phase 3 clinical development programme for once-weekly insulin icodec later in 2020.
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