EASD and ADA recommend the addition of basal insulin for people with T2DM who do not achieve glycemic goals on a GLP-1 RA-based regimen.*2,3
RESTORE-G: Real-world analysis in insulin-naïve adults with T2DM on GLP-1 RA ± OAD(s), intensifying their therapy by starting basal insulin and discontinuing GLP-1 RA, or adding basal insulin to ongoing GLP-1 RA, or initiating a FRC product and discontinuing current GLP-1 RA†1.
~40% of people with T2DM on GLP-1 RA required intensification with basal insulin after a median of ~2 years (primary endpoint).‡1&nbsp;Following intensification with basal insulin, a significant reduction in HbA1c was seen§ and no severe hypoglycemia was recorded.¥1
Toujeo®&nbsp;was associated with greater HbA1c&nbsp;and FBG reductions, and similar weight change vs degludec, in people with T2DM switching from GLP-1 RA therapy to basal insulin.

<h4>Greater HbA1c&nbsp;reduction with Toujeo®&nbsp;vs degludec was also seen in the propensity score matched sensitivity analysis (p=0.02)†‡1</h4>

BMI, body mass index; DPPIV, dipeptidyl peptidase-4; FBG, fasting blood glucose; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HbA1c, hemoglobin A1c&nbsp;; SGLT2, sodium-glucose cotransporter-2.

Baseline characteristics of the populations selected for the comparative effectiveness analysis of Toujeo®&nbsp;vs degludec1

BI, basal insulin; FRC, fixed-ratio combination; GLP-1 RA, glucagon-like peptide-1 receptor agonist; OAD, oral antidiabetic drug; T2DM, type 2 diabetes mellitus.
<h4>Primary endpoint:</h4>
proportion of GLP-1 RA ± OAD treated patients who switched to BI or FRC, or added on BI among all GLP-1 RA-treated patients changing their therapy.
<h4>Secondary endpoints:</h4>
<ul>
 <li>Use of other antidiabetic drugs</li>
 <li>Effectiveness and safety of the different intensification strategies with BI</li>
</ul>

Study design

Each study cohort was stratified by type of BI/FRC prescribed at baseline. Among second generation BIs, cohorts were further stratified by Toujeo®&nbsp;and degludec 100 U/mL.1&nbsp;Propensity score (PS) adjustment was applied. PS was estimated taking into consideration age, gender, diabetes duration, baseline HbA1c, BMI, FBG, BI dose, eGFR &lt;60 mL/min*1.73 m2&nbsp;, history of diabetes complications, concomitant glucose-lowering treatments.1,2&nbsp;Propensity score adjustment was applied only for comparisons including a minimum of 100 patients per group.1
BI, basal insulin; BMI, body mass index; eGFR, estimated glomerular filtration rate; FRC, fixed-ratio combination; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HbA1c, hemoglobin A1c; PS, propensity score.
References:&nbsp;1. Napoli R, et al. RESTORE-G poster presented at the 83rd Scientific Sessions of the American Diabetes Association 2023; June 23–26; San Diego, CA, US. 779-P. 2. Candido R, et al. RESTORE-G poster presented at the 83rd Scientific Sessions of the American Diabetes Association 2023; June 23–26; San Diego, CA, US. 84-LB.

<h4 id="grey-block">2nd&nbsp;generation basal insulins were associated with greater HbA1c&nbsp;and FBG reductions, and similar weight change vs 1st&nbsp;generation analogs, in people with T2DM adding basal insulin to GLP-1 RA therapy.</h4>

Real-world analysis in insulin-naïve adults with T2DM on GLP-1 RA ± OAD(s), intensifying their therapy by adding basal insulin (second- or a first-generation analog) to ongoing GLP-1 RA.1,2

*This predefined sub-analysis is propensity score adjusted taking into account baseline differences. All models were adjusted for propensity scores estimated taking into account age, gender, diabetes duration, baseline HbA1c, BMI, FBG, basal insulin dose, eGFR &lt;60 mL/min*1.73m2, history of diabetes complication, concomitant glucose lowering treatments. Rates of hypoglycemia were not assessed in this comparative sub-analysis.2&nbsp;Propensity score adjustment was applied only for comparisons including a minimum of 100 patients per group.2
1st-gen BIs, first-generation basal insulins; 2nd-gen BIs, second-generation basal insulins, BI, basal insulin; BMI, body mass index; CI, confidence interval; eGFR, estimated glomerular filtration rate; FBG, fasting blood glucose; GLP-1 RA, glucagon-like peptide-1 receptor agonist; HbA1c, hemoglobin A1c; OAD, oral antidiabetic drug; T2DM, type 2 diabetes mellitus.
References:&nbsp;1. Napoli R, et al. Diabetes. 2023;72(Supplement_1):779-P. 2. Napoli R, et al. RESTORE-G poster presented at the 83rd Scientific Sessions of the American Diabetes Association 2023; June 23–26; San Diego, CA, US. 779-P.

Identification of cohorts eligible for predefined and post-hoc comparative effectiveness sub-analyses1,2

1st&nbsp;BI, first-generation basal insulin; 2nd&nbsp;BI, second-generation basal insulin, BMI, body mass index; DPPIV, dipeptidyl peptidase-4; FBG, fasting blood glucose; GLP-1 RA, glucagon-like peptide-1 receptor agonist;
HbA1c, hemoglobin A1c&nbsp;; SGLT2, sodium-glucose cotransporter-2.
Reference:&nbsp;1. Napoli R, et al. RESTORE-G poster presented at the 83rd&nbsp;Scientific Sessions of the American Diabetes Association 2023; June 23–26; San Diego, CA, US. 779-P.

<h4 id="grey-block">Despite significant advances in diabetes management, over 50% of people with diabetes remain uncontrolled.*3,4</h4>

Prevent long-term complications of T2DM
<ol>
 <li>Each 1% reduction in HbA1c&nbsp;is associated with a significant decrease of long-term complications of T2DM5</li>
</ol>

Review &amp; intensify treatment
<ol>
 <li>People with T2DM should have their response to treatment reviewed at a regular intervals4,5</li>
 <li>People with T2DM who do not achieve adequate control on GLP-1-RA should have their treatment intensified with the addition of basal insulin†6,7</li>
</ol>

In real-world practice, adding Toujeo®&nbsp;to GLP-1-RA8
<ol>
 <li>Significantly improved glycemic control</li>
 <li>Without increasing hypoglycemia</li>
 <li>Did not significantly change weight‡</li>
</ol>

Baseline characteristics of the populations selected for the comparative effectiveness analysis of 2nd&nbsp;vs 1st generation BIs1

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RESTORE-G: Real-world analysis in insulin-naïve adults with T2D on GLP-1 RA ± OAD(s), intensifying their therapy by starting basal insulin and discontinuing GLP-1 RA, or adding basal insulin to ongoing GLP-1 RA, or initiating a FRC product and discontinuing current GLP-1 RA†2

The RESTORE-G Real World Evidence Study

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