Objective: To evaluate the effect of anti-IL-21 and liraglutide, alone and in combination, compared to placebo, on preservation of β-cell function after 54 weeks of treatment in adults with recently diagnosed type 1 diabetes. Methods: This was a multicenter, double-dummy, double-blind, efficacy, safety and pharmacokinetic randomized control trial (NCT02443155) in adults recently diagnosed with type 1 diabetes and non-fasting C-peptide peak ≥0.2 nmol/L, comprising a 54-week treatment period followed by a 26-week observation period. Primary endpoint: area under the curve (AUC)0-4h for meal-stimulated C-peptide at week 54 relative to baseline. Results: At week 54, combination treatment was associated with a significant improvement of 48% in meal-stimulated C-peptide secretion versus placebo (Table). The insulin requirement was significantly lowered by 0.13 U/kg. Trends for better glycemic control and lower risk of hypoglycemic episodes at 54 weeks compared to placebo were also observed. No safety concerns were identified. Treatment benefits were not sustained at 26 weeks after end of treatment. Conclusion: Treatment with anti-IL-21 and liraglutide for 54 weeks was safe and resulted in sustained insulin secretion and lower insulin dose. Trends for improved glucose control and fewer hypoglycemic episodes compared to placebo were observed. Disclosure M.G. von Herrath: Employee; Self; Novo Nordisk A/S. S.C. Bain: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp & Dohme Corp., Napp Pharmaceuticals, Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; AstraZeneca. B.W. Bode: Advisory Panel; Self; InPen, Medtronic. Consultant; Self; ADOCIA, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Pfizer Inc. Research Support; Self; Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Gan & Lee Pharmaceuticals, Medtronic, Novo Nordisk A/S, Provention Bio, Inc., Senseonics, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., InPen, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, Novo Nordisk A/S, Sanofi, Sanofi, Senseonics, Xeris Pharmaceuticals, Inc. Stock/Shareholder; Self; Glytec. J. Clausen: Other Relationship; Self; Novo Nordisk A/S. K. Coppieters: Other Relationship; Self; Novo Nordisk A/S. L. Gaysina: None. J. Gumprecht: Consultant; Self; Astra, Bioton, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Polfa Tarchomin S.A., Sanofi, Servier. Speaker’s Bureau; Self; Astra, Bioton, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Polfa Tarchomin S.A., Sanofi, Servier. T.K. Hansen: None. C. Mathieu: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intrexon, MannKind Corporation, Medtronic, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk Inc., Pfizer Inc., Roche Diagnostic USA, Sanofi. Research Support; Self; Intrexon, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk Inc., Sanofi. C. Morales Portillo: Board Member; Self; Novo Nordisk, Lilly, MSD, Astra, Sanofi, Abbot. Research Support; Self; Novo Nordisk, Sanofi, AstraZeneca, Pzifer, Lilly, Merck, Lexicon, FPS, Hanmi, Janssen, Boehringer, Takeda, Roche, Theracos. Speaker’s Bureau; Self; Sanofi, Novo Nordisk, AstraZeneca, Roche, Lilly, Boehringer, MSD, Ferrer, Janssen, Abbot. O. Mosenzon: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Novo Nordisk A/S. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Teva Pharmaceutical Industries Ltd. S. Segel: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. G.M. Tsoukas: Advisory Panel; Self; Amgen, Novo Nordisk Inc. Speaker’s Bureau; Self; Amgen Canada. T. Pieber: Advisory Panel; Self; ADOCIA, Arecor, AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Novo Nordisk A/S. Speaker’s Bureau; Self; Novo Nordisk A/S, Roche Diagnostics K.K. Funding Novo Nordisk A/S
May 14, 2014 marks 200 years since the establishment of the Medical Department of the Imperial Kazan University (now Kazan State Medical University, KSMU). Since the XIX century, scientists of the Kazan Medical School studied physiology and pathology of the endocrine system. The first researchers were interested in the problems of endemic goitre, diabetes mellitus, and function of the adrenal glands. In 1976, the Endocrinology Department was organised in the Kazan State Medical Institute, the first among universities of the RSFSR. The head of the Department, V.V. Talantov, became the chief non-staff endocrinologist of the Ministry of Health of the Republic of Tatarstan (RT) and organiser of the Association of Endocrinologists in the RT. Moreover, he contributed to the organisation of the endocrine service in the republic and endocrinology began to be taught as an independent discipline. V.V. Talantov was a member of the Scientific Council of Endocrinology of the Russian Academy of Medical Sciences, Deputy Chairman of the Committee of Endocrinology Problems of the Ministry of Health, and a member of the editorial boards of four medical journals. The research in the field of endocrinology is now actively continued on the endocrinology course at KSMU. In-depth study of various aspects of the pathogenesis of diabetes and its complications was selected as the first-priority.
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