BOSTON — People with type 1 diabetes treated with basal insulin peglispro demonstrated significantly lower HbA1c levels at 26 and 52 weeks than those treated with insulin glargine, according to data presented at the American Diabetes Association (ADA) 75th Scientific Sessions.
At the conference, researchers reported data from the IMAGINE-1 and IMAGINE-3 clinical trials evaluating basal insulin peglispro in comparison to insulin glargine in patients with type 1 diabetes.
In IMAGINE-1, which is a phase 3, open-label, 78-week study, the researchers randomly assigned 455 patients with type 1 diabetes to bedtime basal insulin peglispro (n=295) or insulin glargine (n=160) in combination with mealtime insulin.
IMAGINE-3 is a phase 3, double-blind, 52-week study in which the researchers randomly assigned 1,114 patients with type 1 diabetes to bedtime basal insulin peglispro (n=664) or insulin glargine (n=45) with prandial insulin lispro.
In IMAGINE -1, results indicated that patients taking basal insulin peglispro had lower HbA1c at the primary endpoint of 26 weeks than those taking insulin glargine (7.1% vs. 7.4%). Similar results were noted in the IMAGINE-3 trial at the primary endpoint of 52 weeks (7.4% vs. 7.6%), according to the data.
Further, significantly more patients taking basal insulin peglispro, as compared with insulin glargine, reached the recommended target HbA1c of less than 7% in the IMAGINE-1 trial at 26 weeks (44.9% vs. 27.5%) as well as in the IMAGINE-3 trial at 52 weeks (35.3% vs. 26.1%).
Additionally, basal insulin peglispro was associated with a decreased risk for nocturnal hypoglycemia in the trials when compared with insulin glargine, with 1.7 events vs. 2.7 events per patient per 30 days at 26 weeks in IMAGINE-1. In IMAGINE-3, at 52 weeks, there were 1.3 events vs. 2.5 events per patient per 30 days in the basal insulin peglispro vs. insulin glargine groups, respectively.
However, basal insulin peglispro was linked to higher rates of total hypoglycemia, as compared with insulin glargine. At 26 weeks in IMAGINE-1, there were 16.0 events vs. 12.4 events per patient per 30 days, respectively, and at 52 weeks in IMAGINE-3, there were 15.3 events vs. 13.9 events per patient per 30 days, respectively.
An analysis of both trials revealed no significant differences in rates of severe hypoglycemia between the basal insulin peglispro group and the insulin glargine group, but patients taking basal insulin peglispro had higher rates of severe hypoglycemia than those taking insulin glargine in IMAGINE-1 at 26 weeks (39.0 events vs. 16.2 events per 100 patient-years) and similar rates of severe hypoglycemia in IMAGINE-3 at 52 weeks (19.7 events vs. 22.5 events per 100 patient-years).
In terms of weight loss, patients taking basal insulin peglispro experienced weight loss, whereas patients taking insulin glargine experienced weight gain in both IMAGINE-1 at 26 weeks (–2.6 kg vs. +0.7 kg) and IMAGINE-3 at 52 weeks (–0.6 kg vs. +1.2 kg).
Also, in both trials, patients taking basal insulin peglispro vs. insulin glargine experienced an increase in triglycerides. In IMAGINE-3 specifically, patients in the basal insulin peglispro group demonstrated an increase in LDL cholesterol, a decrease in HDL cholesterol and increases in systolic and diastolic blood pressure (BP), as compared with insulin glargine.
However, rates of major adverse cardiac events (MACE), including cardiovascular (CV) death, nonfatal stroke, nonfatal MI and hospitalization for unstable angina, was lower for those taking basal insulin peglispro vs. insulin glargine in IMAGINE-3. No MACE events occurred in IMAGINE-1, according to a press release.
The liver enzyme alanine aminotransferase (ALT) was also increased among those taking basal insulin peglispro in both IMAGINE-1 and IMAGINE-3. These levels decreased toward baseline about 4 weeks after discontinuation. Additionally, liver fat as measured by MRI in a subset of patients in both studies was higher among those treated with basal insulin peglispro vs. insulin glargine.
“In many people with type 1 diabetes, current insulin treatments may not be optimal for a variety of reasons,” Melanie Davies, MD, professor of diabetes medicine at the University of Leicester in the United Kingdom, said in the release.
“Results from the IMAGINE trials showed that [basal insulin peglispro] has a unique combination of benefits, including superior glycemic control, reduced nocturnal hypoglycemia and weight loss, all of which could be beneficial for people who need basal insulin treatment.”
- Garg SK et al. Abstract 95-OR: Greater HbA1c Reduction with Basal Insulin Peglispro (BIL) vs. Insulin Glargine (GL) in an Open-Label, Randomized Study in T1D Patients (pts): IMAGINE-1.
- Bergenstal RM et al. Abstract 986-P: Superior Reduction of HbA1c in a Double-Blind, Randomized Study of Basal Insulin Peglispro (BIL) vs. Insulin Glargine (GL) in Patients (pts) with T1D: IMAGINE-3. Both presented at: American Diabetes Association (ADA) 75th Scientific Sessions; June 5-9, 2015; Boston.