QWINT: Once-weekly basal insulin noninferior to daily insulins in type 2 diabetes
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Key takeaways:
- Adults with type 2 diabetes had an HbA1c reduction of 1.31 percentage points with insulin efsitora alfa in QWINT-1.
- In QWINT-3, insulin efsitora alfa lowered HbA1c by 0.86 percentage points at 26 weeks.
A novel once-weekly basal insulin conferred noninferior HbA1c reductions compared with daily insulins for insulin-naive adults with type 2 diabetes and those who switched from daily injections, according to topline results from two trials.
Once-weekly insulin efsitora alfa (Eli Lilly) is being assessed among different patient populations with type 1 or type 2 diabetes in five phase 3 studies as part of the QWINT trial program. As Healio previously reported, insulin efsitora alfa induced noninferior HbA1c reductions vs. once-daily insulins in adults with type 2 diabetes in the QWINT-2 and QWINT-4 trials. In new topline results announced by Eli Lilly, insulin efsitora alfa again met noninferiority endpoints in two more phase 3 trials, QWINT-1 and QWINT-3.
QWINT-1 topline results
In QWINT-1, 796 adults with type 2 diabetes who did not previously use insulin were randomly assigned to receive once-weekly insulin efsitora alfa or once-daily insulin glargine for 1 year. The insulin efsitora alfa group received a starting dose of 100 U per week for 4 weeks followed by a fixed dose escalation to 150 U for weeks 5 to 8, 250 U for weeks 9 to 12 and 400 U for weeks 13 to 16. Dose escalation continued for each participant until a fasting blood glucose between 80 mg/dL and 130 mg/dL was reached. Flexible dosing was prescribed for those who had a fasting blood glucose of more than 130 mg/dL at or after 16 weeks.
Insulin efsitora alfa met the trial’s primary endpoint for a noninferior HbA1c reduction compared with insulin glargine. In the efficacy estimand, the insulin efsitora alfa group had a reduction of 1.31 percentage points in HbA1c from baseline to 1 year compared with a reduction of 1.27 percentage points for the insulin glargine group. At 1 year, the mean HbA1c was 6.92% for adults receiving insulin efsitora alfa and 6.96% for those receiving insulin glargine.
QWINT-3 topline results
In the QWINT-3 trial, 986 adults with type 2 diabetes who were using basal insulin at baseline were randomly assigned, 2:1, to receive once-weekly insulin efsitora alfa or once-daily insulin degludec for 78 weeks. Participants began their randomly assigned treatment following a 3-week lead-in period. The primary endpoint was change in HbA1c from baseline to 26 weeks.
Adults receiving insulin efsitora alfa had a decrease of 0.86 percentage points in HbA1c from baseline to 26 weeks compared with a reduction of 0.75 percentage points for the insulin degludec group in the efficacy estimand. Mean HbA1c at 26 weeks was 6.93% with insulin efsitora alfa and 7.03% with insulin degludec.
In weeks 22 to 26, the insulin efsitora alfa group spent 62.8% of their time in range with a glucose of 70 mg/dL to 180 mg/dL compared with a 61.3% time in range with insulin degludec. Time in tight range with a glucose of 70 mg/dL to 140 mg/dL was 38.3% with insulin efsitora alfa vs. 36.8% with insulin degludec.
The safety profile of insulin efsitora alfa was similar to the daily insulins in both trials. Combined rates of severe or clinically significant hypoglycemia events with a glucose of less than 54 mg/dL were 0.5 per patient-year of exposure with insulin efsitora alfa vs. 0.88 per patient-year of exposure with insulin glargine in the QWINT-1 trial. In QWINT-3, the rate of severe or clinically significant hypoglycemic events was 0.84 per patient-year of exposure with insulin efsitora alfa vs. 0.74 per patient-year of exposure with insulin degludec.
“Once-weekly insulins, like efsitora, have the potential to transform diabetes care as we know it," Jeff Emmick, MD, PhD, senior vice president of product development for Eli Lilly, said in a press release. “Many patients are reluctant to start insulin because of the burden it places on them. With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives."
Detailed results from both trials will be presented at an upcoming meetings and published in a peer-reviewed journal. Findings from the QWINT-2 and QWINT-5 phase 3 studies will be presented at the European Association for the Study of Diabetes annual meeting.
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