Effect of anti-IL-1β antibody (canakinumab) on insulin secretion rates in impaired glucose tolerance or type 2 diabetes: Results of a randomized, placebo-controlled trial

Diabetes, Obesity and Metabolism

Volumn 14, Issue 12, 2012, Pages 1088-1096

  Rissanen, Aila ^a,k   Howard, C P ^b   Botha, J ^b   Thuren, T ^b   Proietto, Joseph ^c   Nicholson, Geoffrey ^d   Colman, Peter ^e   Aronson, Ronnie ^f   Goldenberg, Ronald ^g   Khandwala, Hasnain ^h   Dumas, Richard ⁱ   Hallé, Jean Pierre ^j   Keinanen Kiukaanniemi, Sirkka ^l   Laine, Merja ^m   Anderten, Helmut ⁿ   Boeckmann, Uwe ^o   Chevts, Julia ^o   Keuthage, Winfried ^p   Funke, Klaus ^q   Khariouzov, Andrei ^r   Luedemann, Joerg ^o   Martin, Stephan ^s   Rau, Thorsten ^o   Schneider, Reinhold ^o   Steinmaier, Gerhard ^o   Venschott Jordan, Ulrike ^t   Zeissig, Ingo ^u   Jain, Sunil ^v   Dharskar, Aarti ^w   Reddy, Sanjay ^x   Srikanta, Sathyanarayana ^y   Subrahmanyam, Kav ^z   Mohan, V ^aa   Nair, Rajendran K ^ab   Kale, Shailaja ^ac   Dotta, Francesco ^ad   Pontiroli, Antonio ^ae   Pagani, Giorgio ^af   Giaccari, Andrea ^ag   Ronchi, Esio ^ah   Piatti, Piermarco ^ai   Viviani, Giorgio Luciano ^aj   Anderson, Robert ^ak   Arena, Charles M ^al   Burton, Robert ^am   Lane, James ^an   Lewin, Andrew ^ao   Lillestol, Michael ^ap   Mitchell, Jerry R ^aq   Palchick, Bryce ^ar   Rosenstock, Julio ^as   Wittmer, Bret ^at   Lipetz, Robert ^au   more..

^a HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^b NOVARTIS PHARMA AG   (Switzerland)

^c HEIDELBERG REPATRIATION HOSPITAL   (Australia)

^d GEELONG HOSPITAL   (Australia)

^e ROYAL MELBOURNE HOSPITAL   (Australia)

^f LMC Endocrinology Centres (Markham) Ltd   (Canada)

^g Lifestyle Metabolism Centres   (Canada)

^h Lifestyle Metabolism Centre (Etobicoke)   (Canada)

ⁱ Department of Medicine   (Canada)

^j MAISONNEUVE ROSEMONT HOSPITAL   (Canada)

^k Lihavuustutkimusyksikk o   (Finland)

^l ODL Terveys   (Finland)

^m L äak arikeskus Mehil ainen T öol o   (Finland)

ⁿ Gemeinschaftspraxis Dres Anderten und Krok   (Germany)

^o Pro ScientiaMed ^*

^p Pro ScientiaMed   (Germany)

^q Sana Krankenhaus Gerresheim   (Germany)

^r EPO GmbH   (Germany)

^s SANA KLINIKUM OFFENBACH   (Germany)

^t Visakha Diabetes and Endocrine Centre   (Germany)

^u HNO Gemeinschaftspraxis   (Germany)

^v Research Division   (India)

^w Sahyadri Hospital   (India)

^x Bangalore Baptist Hospital   (India)

^y Jnana Sanjeevini Medical Center   (India)

^z Endocrine and Diabetes Centre   (India)

^aa MADRAS DIABETES RESEARCH FOUNDATION   (India)

^ab Azienda Ospedaliera della provincia di Pavia   (India)

^ac Sahyadri Speciality Hospital Pune   (India)

^ad UNIVERSITY HOSPITAL OF SIENA   (Italy)

^ae FATEBENEFRATELLI HOSPITAL   (Italy)

^af OSPEDALI RIUNITI   (Italy)

^ag FONDAZIONE POLICLINICO UNIVERSITARIO A GEMELLI IRCCS   (Italy)

^ah Ospedale C Mira   (Italy)

^ai SAN RAFFAELE HOSPITAL   (Italy)

^aj UNIVERSITY OF GENOA   (Italy)

^ak VA NEBRASKA WESTERN IOWA HEALTH CARE SYSTEM   (United States)

^al Preferred Primary Care Physicians   (United States)

^am Crest Clinical Trials Inc   (United States)

^an UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^ao NATIONAL RESEARCH INSTITUTE   (United States)

^ap Lillestol Research LLC   (United States)

^aq Texas Center for Drug Development   (United States)

^ar Preferred Primary Care Physicians   (United States)

^as DALLAS DIABETES AND ENDOCRINE CENTER AT MEDICAL CITY   (United States)

^at Encompass Clinical Research ^*  (United States)

^au Encompass Clinical Research   (United States)

more..

Author keywords

Diabetes mellitus; Glucose intolerance; Insulin; Interleukin 1

Indexed keywords

CANAKINUMAB; GLITAZONE DERIVATIVE; GLUCOSE; INSULIN; METFORMIN; PLACEBO; SULFONYLUREA; 2,4 THIAZOLIDINEDIONE DERIVATIVE; 2,4-THIAZOLIDINEDIONE; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; INTERLEUKIN 1BETA; MONOCLONAL ANTIBODY; SULFONYLUREA DERIVATIVE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DIABETIC PATIENT; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; HYPERGLYCEMIA; HYPERHIDROSIS; HYPOGLYCEMIA; IMPAIRED GLUCOSE TOLERANCE; INFLAMMATION; INSULIN RELEASE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREAS ISLET BETA CELL; PARALLEL DESIGN; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TREMOR; ADOLESCENT; ANTAGONISTS AND INHIBITORS; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION; GLUCOSE INTOLERANCE; IMMUNOLOGY; METABOLISM; MIDDLE AGED; SECRETION (PROCESS); TREATMENT OUTCOME; BLURRED VISION; BRONCHITIS; CONFUSION; DIARRHEA; DIET RESTRICTION; DYSPEPSIA; DYSPHONIA; HORDEOLUM; NAUSEA; PAPULAR RASH; PHARYNGITIS; RHINOPHARYNGITIS; SINGLE DRUG DOSE; VERTIGO; VISUAL IMPAIRMENT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCOSE INTOLERANCE; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INTERLEUKIN-1BETA; MALE; METFORMIN; MIDDLE AGED; SULFONYLUREA COMPOUNDS; THIAZOLIDINEDIONES; TREATMENT OUTCOME;

EID: 84873271227     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2012.01637.x     Document Type: Article

References (28)

1. Wajchenberg BL. Beta-cell failure in diabetes and preservation by clinical treatment. Endocr Rev 2007; 28: 187-218.
2. Gerich JE. Contributions of insulin-resistance and insulin-secretory defects to the pathogenesis of type 2 diabetes mellitus. Mayo Clin Proc 2003; 78: 447-456.
3. Guillausseau PJ, Meas T, Virally M, Laloi-Michelin M, Medeau V, Kevorkian JP. Abnormalities in insulin secretion in type 2 diabetes mellitus. Diabetes Metab 2008; 34(Suppl. 2): S43-S48.
4. Nathan DM, Buse JB, Davidson MB et al. Medical management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193-203.
5. American Diabetes Association. Standards of medical care in diabetes-2011. Diabetes Care 2011; 34(Suppl. 1): S11-S61.
6. Boni-Schnetzler M, Thorne J, Parnaud G et al. Increased interleukin (IL)- 1beta messenger ribonucleic acid expression in beta -cells of individuals with type 2 diabetes and regulation of IL-1beta in human islets by glucose and autostimulation. J Clin Endocrinol Metab 2008; 93: 4065-4074.
7. Venieratos PD, Drossopoulou GI, Kapodistria KD, Tsilibary EC, Kitsiou PV. High glucose induces suppression of insulin signalling and apoptosis via upregulation of endogenous IL-1beta and suppressor of cytokine signalling-1 in mouse pancreatic beta cells. Cell Signal 2010; 22: 791-800.
8. Lachmann HJ, Lowe P, Felix SD et al. In vivo regulation of interleukin 1beta in patients with cryopyrin-associated periodic syndromes. J Exp Med 2009; 206: 1029-1036.
9. Dinarello CA, Donath MY, Mandrup-Poulsen T. Role of IL-1beta in type 2 diabetes. Curr Opin Endocrinol Diabetes Obes 2010; 17: 314-321.
10. Boni-Schnetzler M, Boller S, Debray S et al. Free fatty acids induce a proinflammatory response in islets via the abundantly expressed interleukin-1 receptor I. Endocrinology 2009; 150: 5218-5229.
11. Mandrup-Poulsen T, Pickersgill L, Donath MY. Blockade of interleukin 1 in type 1 diabetes mellitus. Nat Rev Endocrinol 2010; 6: 158-166.
12. Borjesson A, Carlsson C. Altered proinsulin conversion in rat pancreatic islets exposed long-term to various glucose concentrations or interleukin- 1beta. J Endocrinol 2007; 192: 381-387.
13. Emanuelli B, Glondu M, Filloux C, Peraldi P, Van Obberghen E. The potential role of SOCS-3 in the interleukin-1beta-induced desensitization of insulin signaling in pancreatic beta-cells. Diabetes 2004; 53(Suppl. 3): S97-S103.
14. Masters SL, Dunne A, Subramanian SL et al. Activation of the NLRP3 inflammasome by islet amyloid polypeptide provides a mechanism for enhanced IL-1beta in type 2 diabetes. Nat Immunol 2010; 11: 897-904.
15. Mitroulis I, Skendros P, Ritis K. Targeting IL-1beta in disease; the expanding role of NLRP3 inflammasome. Eur J Intern Med 2010; 21: 157-163.
16. Ehses JA, Lacraz G, Giroix MH et al. IL-1 antagonism reduces hyperglycemia and tissue inflammation in the type 2 diabetic GK rat. Proc Natl Acad Sci USA 2009; 106: 13998-14003.
17. Osborn O, Brownell SE, Sanchez-Alavez M, Salomon D, Gram H, Bartfai T. Treatment with an Interleukin 1 beta antibody improves glycemic control in diet-induced obesity. Cytokine 2008; 44: 141-148.
18. Alten R, Gram H, Joosten LA et al. The human anti-IL-1 beta monoclonal antibody ACZ885 is effective in joint inflammation models in mice and in a proof-of-concept study in patients with rheumatoid arthritis. Arthritis Res Ther 2008; 10: R67.
19. Larsen CM, Faulenbach M, Vaag A et al. Interleukin-1-receptor antagonist in type 2 diabetes mellitus. N Engl J Med 2007; 356: 1517-1526.
20. Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB et al. Use of canakinumab in the cryopyrin-associated periodic syndrome. N Engl J Med 2009; 360: 2416-2425.
21. Lachman HJ, Lowe P, Felix SD et al. In vivo regulation on interleukin 1β in patients with cryopyrin-associated periodic syndromes. J Exp Med 2009; 206: 1029-1036.
22. Cobelli C, Mari A, Del Prato S, De Kreutzenberg S, Nosadini R, Jensen I. Reconstructing the rate of appearance of subcutaneous insulin by deconvolution. Am J Physiol 1987; 253(5 Pt. 1): E584-E590.
23. van Cauter E, Mestrez F, Sturis J, Polonsky KS. Estimation of insulin secretion rates from C-peptide levels: comparison of individual and standard kinetic parameters for C-peptide clearance. Diabetes 1992; 41: 368-377.
24. Schlesinger N, De Meulemeester M, Pikhlak A et al. Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study. Arthritis Res Ther 2011; 13: R53.
25. So A, De Meulemeester M, Pikhlak A et al. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: results of a multicenter, phase II, dose-ranging study. Arthritis Rheum 2010; 62: 3064-3076.
26. Kuemmerle-Deschner JB, Ramos E, Blank N et al. Canakinumab (ACZ885, a fully human IgG1 anti-IL-1beta mAb) induces sustained remission in pediatric patients with cryopyrin-associated periodic syndrome (CAPS). Arthritis Res Ther 2011; 13: R34.
27. Masters SL, Latz E, O'Neill LA. The inflammasome in atherosclerosis and type 2 diabetes. Sci Transl Med 2011; 3: 81ps17.
28. Ridker PM, Thuren T, Zalewski A, Libby P. Interleukin-1β inhibition and the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS). Am Heart J 2011; 162: 597-605.