- In this treat-to-target trial, Tresiba® and insulin glargine U-100 produced similar A1C reductions (–0.36% vs –0.34%, respectively)
- Baseline: Tresiba®, 7.7%; insulin glargine U-100, 7.7%
- End of trial: Tresiba®, 7.3%; insulin glargine U-100, 7.3%
- At week 52, the difference in A1C reduction from baseline between Tresiba® and insulin glargine U-100 was –0.01% (95% CI, -0.14% to 0.11%) and met the prespecified noninferiority margin (0.4%)
Powerful A1C and fasting plasma glucose (FPG) reductions in a 52-week study in adults with type 1 diabetes1
- Tresiba® and insulin glargine U-100 produced similar FPG results in this trial: Tresiba®, –27.6 mg/dL; insulin glargine U-100, –21.6 mg/dL
- Baseline: Tresiba®, 165 mg/dL; insulin glargine U-100, 174 mg/dL
- End of trial: Tresiba®, 141 mg/dL; insulin glargine U-100, 149 mg/dL
bSevere hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
cNovo Nordisk–defined hypoglycemia: a severe hypoglycemia event or an event where laboratory or self-measured glucose calibrated to plasma was <56 mg/dL or where whole blood glucose was <50 mg/dL (ie, with or without the presence of hypoglycemic symptoms).
BEGIN: Basal-Bolus Type 11,2
Population: Adults with type 1 diabetes.
Study design: 52-week, randomized, open-label, multicenter trial comparing the efficacy and safety of once-daily Tresiba® U-100 (n=472) and once-daily insulin glargine U-100 (n=157). Insulin aspart was administered before each meal in both treatment arms. Basal insulin was titrated to an FPG target of 70 to 90 mg/dL according to mean prebreakfast self-measured plasma glucose (SMPG) values (mean of 3 consecutive days). Bolus insulin was titrated to preprandial (of next meal) and bedtime SMPG concentrations of 70 to 90 mg/dL.
Primary endpoint: Change in A1C from baseline after 52 weeks of treatment.
Mean end-of-trial basal insulin dose: Tresiba®, 29 units; insulin glargine U-100, 31 units.
End-of-trial daily bolus insulin dose: Tresiba® arm: Tresiba®, 29 units; insulin aspart, 32 units; insulin glargine U-100 arm: insulin glargine, 31 units; insulin aspart, 35 units.
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aFor up to 24 months. Maximum savings of $500 per prescription. Eligibility and other restrictions apply.
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Adult patients who miss a dose of Tresiba® should inject their daily dose during waking hours upon discovering the missed dose, then continue with their regular dosing schedule. Ensure that at least 8 hours have elapsed between Tresiba® injections.1
dAfter the last of 8 once-daily injections (0.4 units/kg).