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Grand Rounds

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

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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

METHODS:

  • 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

RESULTS:

  • 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

CONCLUSION:

  • 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

Learn More – Primary Sources:

Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment

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Related ObG Topics:

Treating Type 2 Diabetes
Update from the ACP: New Hemoglobin A1c Targets for Type 2 Diabetes Mellitus
Does Automated Insulin Dosing Guidance Optimize Management in Patients with Type 2 Diabetes?
Multiple Injections or Continuous Insulin Infusion for Type 1 Diabetes Mellitus in Pregnancy?
CONCEPTT Study: Time for Continuous Glucose Monitoring for All Pregnant Women with Type 1 Diabetes?

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