Double-blind, randomized study evaluating the glycemic and anti-inflammatory effects of subcutaneous LY2189102, a neutralizing IL-1β antibody, in patients with type 2 diabetes

  • Diabetes Care. 2013 Aug;36(8):2239-46. doi: 10.2337/dc12-1835.
Joanne Sloan-Lancaster  1 ,  Eyas Abu-Raddad ,  John Polzer ,  Jeffrey W Miller ,  Joel C Scherer ,  Andrea De Gaetano ,  Jolene K Berg ,  William H Landschulz
Affiliations
  • 1. 1Chorus, Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, Indiana, USA [email protected]
PMID: 23514733 DOI: 10.2337/dc12-1835
Abstract

Objective: Inflammation is associated with pancreatic β-cell Apoptosis and reduced Insulin sensitivity. Literature suggests that interleukin (IL)-1β may contribute to the pathogenesis of type 2 diabetes mellitus (T2DM). This study aimed to determine the efficacy, safety, and tolerability of LY2189102, a neutralizing IL-1β antibody, in T2DM patients.

Research design and methods: Phase II, randomized, double-blind, parallel, placebo-controlled study of subcutaneous LY2189102 (0.6, 18, and 180 mg) administered weekly for 12 weeks in T2DM patients on diet and exercise, with or without approved antidiabetic medications.

Results: LY2189102 reduced HbA1c at 12 weeks (adjusted mean differences versus placebo: -0.27, -0.38 and -0.25% for 0.6, 18 and 180 mg doses, respectively), and fasting glucose at multiple time points compared with placebo. LY2189102 also reduced postprandial glycemia, and inflammatory biomarkers, including hs-CRP and IL-6. LY2189102 was generally well tolerated.

Conclusions: Weekly subcutaneous LY2189102 for 12 weeks was well tolerated, modestly reduced HbA1c and fasting glucose, and demonstrated significant anti-inflammatory effects in T2DM patients. Neutralizing IL-1β holds promise as a convenient Adjuvant treatment for T2DM.

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