Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study

Frías, Juan P.; Chien, Jenny Y.; Cosson, E.; Landschulz, William; Syring, Kristen; Wullenweber, Paula; Haupt, Axel; Kazda, C.

doi:10.1016/s2213-8587(22)00388-6

Cited by 35 publications

(60 citation statements)

References 27 publications

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“…This 26-week, treat-to-target study was conducted using a conservative BIF titration algorithm to assess efficacy and safety in people with T1D. The study was designed prior to the results were available of the phase 2 study in patients with T2D previously treated with basal insulin ( 8 ).…”

Section: Discussionmentioning

confidence: 99%

“…An effective once-weekly basal insulin would need to provide predictable pharmacokinetic and pharmacodynamic profiles without increasing the risk of hypoglycemia for patients with diabetes. Recently, a phase 2 study of patients with type 2 diabetes (T2D) previously treated with basal insulin indicated that BIF is safe and efficacious as a once-weekly treatment ( 8 ). In fact, BIF demonstrated noninferior glycemic control versus daily insulin degludec as measured by HbA 1c change from baseline to treatment end point.…”

Section: Introductionmentioning

confidence: 99%

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Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes

Kazda¹,

Bue-Valleskey

Chien

et al. 2023

Diabetes Care

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OBJECTIVE Basal Insulin Fc (BIF; insulin efsitora alfa; LY3209590), a fusion protein combining a novel single-chain insulin variant with a human IgG Fc domain, is designed for once-weekly basal insulin administration. This phase 2 study assessed safety and efficacy of BIF versus degludec in 265 patients with type 1 diabetes (T1D) using multiple daily injections. RESEARCH DESIGN AND METHODS During this randomized, parallel, open-label study, patients with T1D were randomized (1:1) to receive BIF once weekly or degludec once daily over the 26-week treatment period. Both groups were titrated to a fasting glucose level of 80–100 mg/dL. The primary end point was HbA1c change from baseline to week 26 (noninferiority margin, 0.4%). Secondary end points included percent time in range (TIR) (70–180 mg/dL), continuous glucose monitoring (CGM) fasting glucose (FG) level, and rate of hypoglycemia. RESULTS After 26 weeks, patients receiving BIF had noninferior HbA1c change from baseline versus those receiving degludec, with a statistically significant treatment difference of 0.17% (90% CI 0.01, 0.32; P = 0.07) favoring the comparator. Percent TIR was similar for patients in the BIF (56.1%) and degludec (58.9%; P = 0.112) groups at week 26. FG values were significantly higher for patients receiving BIF (158.8 mg/dL) versus degludec (143.2 mg/dL; P = 0.003). Rates of CGM-derived hypoglycemia were not statistically significantly different for BIF and degludec over 24 h for level 1 (P = 0.960) or level 2 (P = 0.517) hypoglycemia during the treatment period. Occurrence of serious adverse events was similar between the BIF and degludec groups. CONCLUSIONS Once-weekly BIF demonstrated noninferior glycemic control to once-daily degludec (treatment difference: 0.17% favoring degludec) and no difference in hypoglycemia or other safety findings in patients with T1D.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes

Kazda¹,

Bue-Valleskey

Chien

et al. 2023

Diabetes Care

Self Cite

View full text Add to dashboard Cite

show abstract

“…An effective once-weekly basal insulin would need to provide predictable pharmacokinetic and pharmacodynamic profiles without increasing the risk of hypoglycemia for patients with diabetes. Recently, a phase 2 study of patients with type 2 diabetes (T2D) previously treated with basal insulin indicated that BIF is safe and efficacious as a onceweekly treatment (8). In fact, BIF demonstrated noninferior glycemic control versus daily insulin degludec as measured by HbA 1c change from baseline to treatment end point.…”

Section: Discussionmentioning

confidence: 99%

“…This 26-week, treat-totarget study was conducted using a conservative BIF titration algorithm to assess efficacy and safety in people with T1D. The study was designed prior to the results were available of the phase 2 study in patients with T2D previously treated with basal insulin (8).…”

Section: Discussionmentioning

confidence: 99%

Novel Once Weekly Basal Insulin Fc (BIF) Achieved Similar Glycemic Control with A Comparable Safety Profile Versus Insulin Degludec in Patients with Type 1 Diabetes (T1D)

Kazda¹,

Bue-Valleskey²,

Chien³

et al. 2023

Preprint

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Objective Basal Insulin Fc (BIF; insulin efsitora alfa; LY3209590), a fusion protein combining a novel single-chain insulin variant with a human IgG Fc domain, is designed for once weekly basal insulin administration. This Phase 2 study assessed safety and efficacy of BIF versus degludec in N=265 patients with type 1 diabetes (T1D) using multiple daily injections. Research Design and Methods During this randomized, parallel, open-label study, patients with T1D were randomized (1:1) to receive BIF once weekly or degludec once daily over the 26-week treatment period. Both groups were titrated to fasting glucose 80-100 mg/dL. Primary endpoint was HbA1c change from baseline to Week 26 (non-inferiority margin=0.4%). Secondary endpoints included percent time in range (TIR, 70-180 mg/dL), CGM fasting glucose (FG), and rate of hypoglycemia. Results After 26 weeks, BIF demonstrated non-inferior HbA1c change from baseline versus degludec with a statistically significant treatment difference of 0.17% (90% CI=0.01, 0.32; p=0.07) favoring the comparator. Percent TIR was similar for BIF (56.1%) and degludec (58.9%; p=0.112) at Week 26. FG values were significantly higher for BIF (158.8 mg/dL) versus degludec (143.2 mg/dL; p=0.003). Rates of CGM-derived hypoglycemia were not statistically significantly different for BIF and degludec over 24 hours for Level 1 (p=0.960) or Level 2 (p=0.517) during the treatment period. Occurrence of serious adverse events was similar between BIF and degludec. Conclusions Once weekly BIF demonstrated non-inferior glycemic control to once daily degludec (treatment difference: 0.17% favoring degludec) and no difference in hypoglycemia or other safety findings in patients with T1D.

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“…This low peak-to-trough ratio may result in more stable glucose levels both within and between days. BIF also showed effective glycemic control in a phase 2 study of people with T2D previously treated with a basal insulin ( 7 ). Icodec is a novel basal insulin analog with a half-life of ∼1 week ( 8 ).…”

Section: Introductionmentioning

confidence: 99%

Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial

Bue-Valleskey

Kazda²,

et al. 2023

Diabetes Care

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OBJECTIVE Basal insulin Fc (BIF) (insulin efsitora alfa; LY3209590), a fusion protein combining a novel single-chain insulin variant with a human IgG Fc domain, is designed for once-weekly basal insulin administration. This phase 2 study assessed the safety and efficacy of BIF versus degludec in insulin-naive patients with type 2 diabetes (T2D) previously treated with oral antihyperglycemic medications. RESEARCH DESIGN AND METHODS During this randomized, parallel, open-label study, 278 insulin-naive patients with T2D were randomly assigned (1:1) to receive BIF once weekly or degludec once daily over the 26-week treatment period. Both groups were titrated to fasting glucose of 80–100 mg/dL (4.4 to <5.6 mmol/L). The primary end point was HbA1c change from baseline to week 26 (noninferiority margin 0.4%). Secondary end points included fasting blood glucose (FBG), six-point glucose profiles, and rate of hypoglycemia. RESULTS After 26 weeks of treatment, BIF demonstrated a noninferior HbA1c change from baseline versus degludec, with a treatment difference of 0.06% (90% CI −0.11, 0.24; P = 0.56). Both BIF and degludec treatment led to significant reductions in FBG from baseline. At week 26, the between-treatment difference for BIF versus degludec was 4.7 mg/dL (90% CI 0.1, 9.3; P = 0.09). The rate of level 2 hypoglycemia was low and not significantly different between treatment groups (BIF 0.22 events/patient/year, degludec 0.15 events/patient/year; P = 0.64); there was no severe hypoglycemia. The occurrence of treatment-emergent adverse events was also similar between BIF and degludec. CONCLUSIONS Once-weekly BIF achieved excellent glycemic control similar to degludec, with no concerning hypoglycemia or other safety findings.

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Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study

Cited by 35 publications

References 27 publications

Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes

Novel Once-Weekly Basal Insulin Fc Achieved Similar Glycemic Control With a Safety Profile Comparable to Insulin Degludec in Patients With Type 1 Diabetes

Novel Once Weekly Basal Insulin Fc (BIF) Achieved Similar Glycemic Control with A Comparable Safety Profile Versus Insulin Degludec in Patients with Type 1 Diabetes (T1D)

Once-Weekly Basal Insulin Fc Demonstrated Similar Glycemic Control to Once-Daily Insulin Degludec in Insulin-Naive Patients With Type 2 Diabetes: A Phase 2 Randomized Control Trial

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