Novel insulin found as effective as insulin glargine in phase 2 trial
Researchers
have announced results from a phase 2 clinical trial of investigational insulin
icodec, a once-weekly basal insulin analog which were presented during the 80th
Scientific Sessions of the American Diabetes Association.
In the trial, adults with type 2 diabetes
randomized to once-weekly insulin icodec achieved similar blood sugar control
and a similar safety profile compared to adults with type 2 diabetes randomized
to once-daily insulin glargine U100.
This 26-week, randomized, double-blind, double-dummy, treat-to-target phase 2 clinical trial involved 247 insulin-naïve adults with type 2 diabetes inadequately controlled with metformin with or without a DPP-4i. 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 (-1.33 vs -1.15 percentage points, respectively, p=0.08).1 Secondary endpoints included change in fasting plasma glucose (FPG) from baseline to week 26, which was similar for insulin icodec and insulin glargine U100 (-58mg/dL and -54mg/dL respectively), and the change from baseline to week 26 of the mean of the nine-point self-monitoring of blood glucose (SMBG) profile, which was greater for icodec (-7.9 mg/dL; p= 0.01).1
“Many people with type 2 diabetes are reluctant to start on insulin therapy due to the need for daily injections," said Dr. Julio Rosenstock, lead trial investigator and clinical professor of medicine, University of Texas Southwestern Medical Center, US. "I'm truly excited about the potential of such innovative treatments which could reduce the number of basal insulin injections for my patients with diabetes."
Hypoglycemia, also known as a hypo or low blood sugar, was similar for both treatment groups (observed rates of level 2 [<54 100="" 3="" 45.6="" 52.5="" adverse="" an="" and="" arms.1="" between="" dl="" event="" events="" exposure="" for="" glargine="" had="" hypoglycemia="" icodec="" identified="" in="" insulin="" issues="" mg="" nbsp="" new="" no="" of="" once-weekly="" patient="" patients="" per="" proportion="" relation="" respectively="" safety="" severe="" similar="" span="" that="" the="" this="" to="" trial.="" u100="" was="" were="" years="">
This 26-week, randomized, double-blind, double-dummy, treat-to-target phase 2 clinical trial involved 247 insulin-naïve adults with type 2 diabetes inadequately controlled with metformin with or without a DPP-4i. 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 (-1.33 vs -1.15 percentage points, respectively, p=0.08).1 Secondary endpoints included change in fasting plasma glucose (FPG) from baseline to week 26, which was similar for insulin icodec and insulin glargine U100 (-58mg/dL and -54mg/dL respectively), and the change from baseline to week 26 of the mean of the nine-point self-monitoring of blood glucose (SMBG) profile, which was greater for icodec (-7.9 mg/dL; p= 0.01).1
“Many people with type 2 diabetes are reluctant to start on insulin therapy due to the need for daily injections," said Dr. Julio Rosenstock, lead trial investigator and clinical professor of medicine, University of Texas Southwestern Medical Center, US. "I'm truly excited about the potential of such innovative treatments which could reduce the number of basal insulin injections for my patients with diabetes."
Hypoglycemia, also known as a hypo or low blood sugar, was similar for both treatment groups (observed rates of level 2 [<54 100="" 3="" 45.6="" 52.5="" adverse="" an="" and="" arms.1="" between="" dl="" event="" events="" exposure="" for="" glargine="" had="" hypoglycemia="" icodec="" identified="" in="" insulin="" issues="" mg="" nbsp="" new="" no="" of="" once-weekly="" patient="" patients="" per="" proportion="" relation="" respectively="" safety="" severe="" similar="" span="" that="" the="" this="" to="" trial.="" u100="" was="" were="" years="">
"Novo
Nordisk continues to be a leader in insulin innovation, advancing research for
nearly 100 years in order to help improve the lives of those living with
diabetes," said Todd Hobbs, vice president and chief medical officer for
Novo Nordisk in the US. "Data from our phase 2 trial of investigational,
once-weekly icodec showed that in terms of efficacy and safety, icodec was
comparable to insulin glargine U100 and could provide those living with type 2
diabetes a new option allowing for a reduction in the amount of basal insulin
injections from seven to once per week."
Novo
Nordisk expects to initiate the phase 3 clinical development program for
once-weekly insulin icodec later in 2020.
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