ONCE-WEEKLY INSULIN APPROVED BY THE FDA
April 2026
On March 26th, the FDA approved Novo Nordisk’s Awiqli (insulin icodec), the first once-weekly basal insulin. It is specifically indicated for treating adults with type 2 diabetes and is not approved for use in type 1 diabetes. By reducing the frequency of basal injections from 365 to 52 per year, insulin icodec aims to address common barriers to insulin therapy, including injection burden and treatment non-adherence. It is supplied in a prefilled FlexTouch pen that delivers doses in 10-unit increments. The maximum single injection is 700 units; doses requiring more than 700 units must be split into two injections. The pen is expected to be available in pharmacies in the second half of 2026.
In a trial (N=984) comparing it to daily insulin glargine, the Awiqli group had a greater reduction in A1C over 52 weeks (-1.55% vs 1.35%, p=0.02). However, rates of combined clinically significant or severe hypoglycemia were higher in the Awiqli group (0.30 events per person-year of exposure vs 0.16 events), underscoring the importance of proper patient selection when prescribing Awiqli.
A question many providers probably have is how to dose Awiqli. Those instructions are provided below.
- Insulin-naïve patients: 70 units once weekly on the same day each week
- Patients currently on daily basal insulin therapy:
- Give the first Awiqli dose on the day after the last dose of daily basal insulin
- Week 1 dosage (switching from daily basal): One-time starting dose equals 1.5 times the total daily basal dose multiplied by 7, rounded to the nearest 10 units
- Week 2 dosage (switching from daily basal): Previous total daily basal dose multiplied by 7, rounded to the nearest 10 units
- Week 3 dosage and beyond: Titrate from the prior weekly dose based on metabolic needs, blood glucose monitoring, and glycemic goals
- Missed doses: If a dose is missed, administer it as soon as possible within 4 days, then resume weekly dosing one week from the day the missed dose was taken; if more than 4 days have passed, skip the missed dose and take the next dose on the scheduled day; increase glucose monitoring with missed doses
| Example for converting from daily basal insulin to Awiqli | ||
|---|---|---|
| Previous total daily dosage of basal insulin (units) | Week 1 dosage of Awiqli (units) | Week 2 dosage of Awiqli (units) |
| 10 | 110 | 70 |
| 15 | 160 | 110 |
| 20 | 210 | 140 |
| 25 | 260 | 180 |
| 30 | 320 | 210 |
| 35 | 370 | 250 |
| 40 | 420 | 280 |
- Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin, NEJM (2023) [PubMed abstract]
- Insulin chart (Awiqli®)
