Abstract
PREDICTIVE (an ongoing multinational observational study) provides an opportunity to explore the impact of insulin detemir use in routine clinical practice. Here, we report on long-term (52-week) data from a French cohort of patients (n=1772), comprising 643 with type 1 diabetes and 1129 with type 2 diabetes. Patients were prescribed insulin detemir at their physician's discretion and assessed at various visits (baseline, 12 weeks, 26 weeks and 52 weeks). The primary endpoint was the frequency of serious adverse drug reactions, including major hypoglycaemia. Secondary endpoints included minor and nocturnal hypoglycaemia, glycaemic control (HbA(1c), fasting blood glucose and variability of fasting blood glucose) and weight change. The incidence of serious adverse drug reactions was low throughout the study, seen in 10 patients with type 1 diabetes (14 events, 1.6%) and seven with type 2 diabetes (seven events, 0.6%). In both type 1 and type 2 diabetes cohorts, the overall minor and nocturnal hypoglycaemic events were reduced from baseline (P<0.001), with no clinically significant changes in weight from baseline to endpoint. After 52 weeks of treatment with insulin detemir, glycaemic control improved, with reductions in: HbA(1c),...Continue Reading
References
Aug 1, 1994·The Journal of Pediatrics
Dec 10, 1999·Diabetes Care·K S BrydenD B Dunger
Jun 17, 2000·Diabetes Care·M MuggeoG Verlato
Apr 24, 2001·Diabetes Care·H Yki-Järvinen
Aug 14, 2002·International Journal of Obesity and Related Metabolic Disorders : Journal of the International Association for the Study of Obesity·M Korytkowski
Mar 1, 2003·Diabetes Care·Philippe VagueEberhard Draeger
Apr 28, 2004·Diabetes Care·Philip HomeUNKNOWN Study to Evaluate the Administration of Detemir Insulin Efficacy, Safety and Suitability (STEADINESS) Study Group
Jun 29, 2004·Clinical Therapeutics·David Russell-JonesJan Bolinder
Aug 10, 2004·Diabetologia·K HermansenM A Gall
Nov 10, 2004·Diabetes Research and Clinical Practice·K RaslováN Hâncu
Jan 12, 2005·Diabetes, Obesity & Metabolism·T HaakW Waldhäusl
Jan 12, 2005·Diabetes, Obesity & Metabolism·I De LeeuwJ W F Elte
Feb 5, 2005·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Therese M Chapman, Caroline M Perry
Feb 18, 2005·NeuroRx : the Journal of the American Society for Experimental NeuroTherapeutics·John Concato
Jun 25, 2005·Diabetic Medicine : a Journal of the British Diabetic Association·T R PieberV Grill
Oct 27, 2005·Diabetes Care·Mark PeyrotUNKNOWN International DAWN Advisory Panel
Feb 2, 2006·Expert Opinion on Pharmacotherapy·Philip Home, Peter Kurtzhals
Apr 13, 2006·JAMA : the Journal of the American Medical Association·Louis MonnierClaude Colette
May 30, 2006·Diabetes Care·Kjeld HermansenPhilip Home
Jun 28, 2006·Diabetes Care·Eric S KilpatrickStephen L Atkin
Jul 18, 2006·Diabetic Medicine : a Journal of the British Diabetic Association·K KølendorfS R Heller
Nov 15, 2006·The Diabetes Educator·Catherine Carver
Dec 13, 2006·Clinical Therapeutics·Athena Philis-TsimikasBirger Thorsteinsson
Jan 18, 2007·Diabetic Medicine : a Journal of the British Diabetic Association·K J RobertsonJ Ludvigsson
Mar 9, 2007·Diabetes Research and Clinical Practice·Nish Chaturvedi
Mar 30, 2007·Diabetes, Obesity & Metabolism·H-J LüddekeUNKNOWN PREDICTIVE Study Group
Jul 7, 2007·Eating and Weight Disorders : EWD·S Tierney
Aug 2, 2007·Diabetes/metabolism Research and Reviews·J H DevriesT R Pieber
Nov 27, 2007·Clinical Therapeutics·Robert J LigthelmPaul Valensi
Dec 22, 2007·Current Medical Research and Opinion·Anne DornhorstUNKNOWN PREDICTIVE Study Group
Jan 22, 2008·Diabetologia·J RosenstockG Schernthaner
Apr 5, 2008·Diabetic Medicine : a Journal of the British Diabetic Association·P C BartleyA Philotheou
Aug 8, 2008·Primary Care Diabetes·Robert Ligthelm, Jaime Davidson
Nov 27, 2008·Diabetes·Philip E Cryer
Citations
Feb 18, 2011·Diabetologia·J YoonA Chait
Nov 1, 2012·Drugs·Gillian M Keating
Oct 13, 2011·Expert Opinion on Pharmacotherapy·Gabriele PerrielloFrancesco Zaccardi
Nov 4, 2011·Current Medical Research and Opinion·Robert J Ligthelm
May 11, 2012·Medicina clínica·Jorge Manzarbeitia Arambarri, Leocadio Rodríguez Mañas
Jan 18, 2012·Diabetic Medicine : a Journal of the British Diabetic Association·V V ShenoyH D McIntyre
Oct 2, 2015·Advances in Therapy·Jean-Francois GautierPierre Gourdy
Oct 16, 2015·BMC Endocrine Disorders·Marcin CzechMichał Jakubczyk
Oct 31, 2017·Current Diabetes Reports·Ulrik Pedersen-Bjergaard, Birger Thorsteinsson
Jul 8, 2015·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Grace LedetTarun K Mandal