Once-weekly Basal Insulin Fc (BIF) demonstrated similar glycaemic control to once-daily Insulin Degludec (IDeg) in insulin-naïve patients with Type 2 Diabetes (T2D)

Question How does once-weekly Basal Insulin Fc (BIF) compare against once-daily Insulin Degludec (IDeg) in normalising glycaemic control in insulin-naïve patients with type 2 diabetes (T2D)?

Methodology This randomized, parallel, open-label phase 2 study assessed safety and efficacy of BIF vs IDeg in insulin-naïve patients with T2D previously treated with oral anti-hyperglycaemic medication. BIF was injected once-weekly, and IDeg was injected once-daily. Both groups were titrated to achieve a fasting blood glucose (FBG) ≤ 100mg/dL. The primary endpoint was HbA1c change from baseline (CFBL) to Week 26 (non-inferiority margin=0.4%).

Results Patients were randomized to BIF (N=129) or IDeg (N=135) with a mean age of 58.4 years and baseline HbA1c of 8.0%. After 26 weeks, BIF showed non-inferiority vs IDeg for HbA1c CFBL, with a treatment difference of 0.06% [90% CI=-0.11, 0.24]; p=.56, and both groups had > 75% time in range (70-180mg/dL) on average at week 24-26 CGM assessment. BIF and IDeg significantly reduced FBG from baseline (treatment difference BIF vs IDeg=4.7mg/dL [90% CI=0.1, 9.3]; p=.09). Rate of Level 2 hypoglycaemia was low and not significantly different (BIF=0.22; Deg=0.15 events/pt/yr; p=0.64). No severe hypoglycaemia events were reported. Occurrence of treatment-emergent adverse events was similar between BIF and IDeg.

Conclusions Once-weekly BIF achieved excellent glycaemic control similar to IDeg with no concerning hypoglycaemia or other safety findings, supporting continued development of BIF in Phase 3.

 

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Interessenkonflikt

Juliana Bue-Valleskey: Employee; Stock/Shareholder, Eli Lilly and Company; Christof Kazda: Employee; Stock/Shareholder, Eli Lilly and Company.; Chenchen Ma: Employee; Stock/Shareholder, Eli Lilly and Company.; Jenny Chien: Employee; Stock/Shareholder, Eli Lilly and Company.; Qianyi Zhang: Employee; Stock/Shareholder, Eli Lilly and Company.; Emmanuel Chigutsa: Employee; Stock/Shareholder, Eli Lilly and Company.; William Landschulz: Employee; Stock/Shareholder, Eli Lilly and Company.; Axel Haupt: Employee; Stock/Shareholder, Eli Lilly and Company.; Juan Pablo Frias: Advisory Panel; Altimmune, Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi. Consultant; 89bio, Inc., Akero Therapeutics, Inc., Altimmune, Becton, Dickinson and Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Sanofi. Research Support; Afimmune Limited, Akero Therapeutics, Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi. Speaker's Bureau; Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi

Publication History

Article published online:
02 May 2023