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
| Autor: | Andrea De Gaetano, William H. Landschulz, John Polzer, Jeffrey W. Miller, Eyas Abu-Raddad, Jolene K. Berg, Joel C Scherer, Joanne Sloan-Lancaster |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Blood Glucose Male medicine.medical_specialty endocrine system diseases Endocrinology Diabetes and Metabolism Interleukin-1beta Anti-Inflammatory Agents Type 2 diabetes Antibodies Monoclonal Humanized Placebo Gastroenterology law.invention Placebos Double-Blind Method Randomized controlled trial law Internal medicine Diabetes mellitus Internal Medicine medicine Humans Hypoglycemic Agents Aged Original Research Glycemic Glycated Hemoglobin Advanced and Specialized Nursing business.industry Clinical Care/Education/Nutrition/Psychosocial Research nutritional and metabolic diseases Type 2 Diabetes Mellitus Middle Aged medicine.disease Antibodies Neutralizing Endocrinology Postprandial Diabetes Mellitus Type 2 Tolerability Female business |
| Zdroj: | Diabetes Care |
| ISSN: | 1935-5548 0149-5992 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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