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AWARD-PEDS trial investigating use of Trulicity in youth and adolescents with type 2 diabetes showed superiority in A1C reduction vs placebo.- Eli Lilly

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Published:5th Jun 2022

In the phase III AWARD-PEDS clinical trial from Eli Lilly, Trulicity (dulaglutide) (at 0.75 mg and 1.5 mg doses) led to superior A1C reductions at 26 weeks versus placebo in youth and adolescents (ages 10 to 17 years old) with type 2 diabetes inadequately controlled with diet and exercise, with or without metformin and/or basal insulin.

The study met all of its primary and secondary glycemic control objectives: percent of patients achieving A1C of <7%, fasting plasma glucose (fpg) change from baseline and mean change in a1c in the individual dose groups. significant reductions in both a1c and fasting glucose were observed through week 26 compared to placebo.></7%,>

Among patients treated with Trulicity (pooled data), 51.5% reached an A1C of <7% based on treatment regimen estimand.></7%>

The study achieved this primary objective, and both doses of Trulicity (0.75 mg and 1.5 mg) achieved superior and statistically significant A1C reductions from baseline compared to placebo and also achieved significant results for key secondary endpoints of glycemic control at 26 weeks.

For the efficacy estimand, results showed : i. Adjusted (least squares mean) A1C reduction compared to placebo: -1.0% (p=0.002, Trulicity 0.75 mg), -1.5% (p<0.001, trulicity 1.5 mg), -1.3% (p><0.001, trulicity pooled doses). patients assigned to placebo had an adjusted (least squares mean) a1c increase from baseline of +0.5% ii. percent of participants achieving a1c><7%: 60.0% (p><0.001, trulicity 0.75 mg), 53.2% (p><0.001, trulicity 1.5 mg), 56.5% (p><0.001, trulicity pooled doses), 18.4% (placebo). iii. adjusted (least squares mean) fasting glucose reduction compared to placebo: -25.9 mg dl (p="0.021," trulicity 0.75 mg), -45.1 mg dl (p><0.001, trulicity 1.5 mg), -35.5 mg dl (p><0.001, trulicity pooled doses). patients assigned to placebo had an adjusted (least squares mean) fasting glucose increase from baseline of +17.3 mg dl. iv. rescue therapy administration compared to placebo: 2.9% (trulicity), 17.6% (placebo). v. adjusted (least squares mean) change in bmi: -0.2 kg m2 (trulicity 0.75 mg), -0.1 kg m2 (trulicity 1.5 mg), -0.1 kg m2 (trulicity pooled doses), 0.0 kg m2 (placebo). trulicity did not have significant effect versus placebo on bmi through 26 weeks.></0.001,></0.001,></0.001,></0.001,></0.001,></7%:></0.001,></0.001,>

The treatment-regimen estimand results showed: i. Adjusted (least squares mean) A1C reduction compared to placebo: -1.2% (p<0.001, trulicity 0.75 mg), -1.5% (p><0.001, trulicity 1.5 mg), -1.4% (p><0.001, trulicity pooled doses). patients assigned to placebo had an adjusted (least squares mean) a1c increase from baseline of +0.6%. ii percent of participants achieving a1c><7%: 54.9% (p><0.001, trulicity 0.75 mg), 48.1% (p><0.001, trulicity 1.5 mg), 51.5% (p><0.001, trulicity pooled doses), 13.7% (placebo).iii. adjusted (least squares mean) fasting glucose reduction compared to placebo: -29.9 mg dl (p="0.005," trulicity 0.75 mg), -42.0 mg dl (p><0.001, trulicity 1.5 mg), -35.9 mg dl (p><0.001, trulicity pooled doses). patients assigned to placebo had an adjusted (least squares mean) fasting glucose increase from baseline of +17.1 mg dl. the overall safety profile of trulicity in the award-peds trial was consistent with its known safety profile in adults with type 2 diabetes. the study was presented in a poster at the american diabetes association's (ada) 82nd scientific sessions and simultaneously published in the new england journal of medicine.></0.001,></0.001,></0.001,></0.001,></0.001,></7%:></0.001,></0.001,></0.001,>

See- "Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes": Silva A. Arslanian, M.D., Tamara Hannon, M.D., Philip Zeitler, M.D., Ph.D. et al., for the AWARD-PEDS Investigators.-June 4, 2022. DOI: 10.1056/NEJMoa2204601.

Condition: Diabetes Type 2
Type: drug

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