Grand Rounds

RCT Results: Once-Weekly Insulin Injection for Type 2 Diabetes

BACKGROUND AND PURPOSE:

There is often a delay in escalation to insulin treatment in patients with type 2 diabetes (T2D)
- Less frequent injections could improve initiation timing and adherence
- Insulin icodec (proposed international nonproprietary name) is a basal insulin analogue in development that is designed for once-weekly administration
Rosenstock et al. (NEJM, 2020) report on results from a phase 2 clinical trial investigating the efficacy and safety of once-weekly insulin icodec as vs once-daily insulin glargine

26-week, randomized, double-blind, double-dummy, phase 2 trial
Participants
- Patients with T2D who had not previously received long-term insulin treatment and were inadequately controlled with metformin +/- a dipeptidyl peptidase 4 inhibitor
Adequately control definition: A1C level 7.0 to 9.5%
Hypoglycemia definitions
- Clinically significant (level 2): <54 mg per deciliter (<3.0 mmol per liter)
- Severe (level 3): Severe cognitive impairment requiring external assistance for recovery
Interventions
- Once-weekly insulin icodec
- Once-daily insulin glargine U100
Primary outcome
- Change in A1C from baseline to week 26
Safety outcomes
- Episodes of hypoglycemia
- Insulin-related adverse events

247 participants
- Baseline A1C levels were similar in the two groups
  - Icodec: 8.09%
  - Glargine: 7.96%
Estimated mean change from baseline
- Icodec: -1.33 percentage points
- Glargine: -1.15 percentage points
Estimated mean levels at 26 weeks
- Icodec: 6.69%
- Glargine: 6.87%
Estimated between-group difference in the change from baseline was not statistically significant (P=0.08)
- −0.18 percentage points (95% CI, –0.38 to 0.02)
- Nor were there statistical differences between groups in the percentage of patients achieving A1C levels ≤7% or ≤6.5%
Rates of level 2 or 3 hypoglycemia were low and did not statistically differ between groups
- Icodec: 0.53 events per patient-year
- Glargine: 0.46 events per patient year
- Estimated rate ratio 1.09 (95% CI, 0.45 to 2.65)
There was no between-group difference in insulin-related key adverse events
- Rates of hypersensitivity and injection-site reactions were also low
- Most adverse events were mild, and no serious events were deemed to be related to the trial medications

Once-weekly insulin icodec treatment was as effective as once-daily glargine U100 for lowering glucose levels in patients with type 2 diabetes
In addition, both treatments had similar safety profiles

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