Online citations, reference lists, and bibliographies.
Please confirm you are human
(Sign Up for free to never see this)
← Back to Search

Insulin Detemir Improves Glycaemic Control With Less Hypoglycaemia And No Weight Gain: 52-week Data From The PREDICTIVE Study In A Cohort Of French Patients With Type 1 Or Type 2 Diabetes.

M. Marre, M. Pinget, H. Gin, C. Thivolet, H. Hanaire, J. Robert, P. Fontaine
Published 2009 · Medicine

Save to my Library
Download PDF
Analyze on Scholarcy
Share
AIM 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. METHODS 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. RESULTS 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), by -0.6% and -0.8% in type 1 and type 2 diabetes patients, respectively; fasting blood glucose, by -1.4mmol/L and -1.9mmol/L respectively; and FBG variability, by -0.8mmol/L and -0.3mmol/L, respectively (P<0.0001 for all). CONCLUSION Patients treated with insulin detemir in a clinical healthcare setting improved their glycaemic control with no increases in hypoglycaemia, adverse events or weight compared with baseline.
This paper references
A randomized , 52 - week , treattotarget trial comparing insulin detemir with insulin glargine when administered as add - on to glucoselowering drugs in insulinnaive people with type 2 diabetes
J Rosenstock (2008)
10.1111/j.1464-5491.2007.02407.x
Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal–bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial
P. C. Bartley (2008)
10.1517/14656566.7.3.325
Insulin detemir: from concept to clinical experience
P. Home (2006)
Safety and efficacy of insulin detemir basalbolus therapy in type 1 diabetes patients : 14 - week data from the European cohort of the PREDICTIVETM study
Luddeke H-J (2008)
10.2337/dc08-9016
Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy
D. Nathan (2008)
10.1002/dmrr.762
Refining basal insulin therapy: what have we learned in the age of analogues?
J. DeVries (2007)
10.1007/BF03327587
Control and disordered eating in type 1 diabetes
S. Tierney (2007)
10.1016/J.DIABRES.2007.01.019
The burden of diabetes and its complications: trends and implications for intervention.
N. Chaturvedi (2007)
10.1001/JAMA.295.14.1681
Activation of oxidative stress by acute glucose fluctuations compared with sustained chronic hyperglycemia in patients with type 2 diabetes.
L. Monnier (2006)
10.2337/dc06-1610
The Effect of Glucose Variability on the Risk of Microvascular Complications in Type 1 Diabetes
I. Hirsch (2007)
10.1097/00019616-199903000-00016
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes
UKPDS (2002)
Once - daily insulin detemir improves glycemic control and tolerability in patients with types 1 or 2 diabetes enrolled for 26 weeks in the PREDICTIVETM study
A Dornhorst (2007)
10.1111/j.1463-1326.2004.00373.x
Lower within‐subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes
T. Haak (2005)
10.1602/neurorx.1.3.341
Observationalversus experimental studies: What’s the evidence for a hierarchy?
J. Concato (2011)
10.2337/DIACARE.23.1.45
Fasting plasma glucose variability predicts 10-year survival of type 2 diabetic patients: the Verona Diabetes Study.
M. Muggeo (2000)
10.1111/j.1464-5491.2007.02024.x
Insulin detemir compared with NPH insulin in children and adolescents with Type 1 diabetes
K. Robertson (2007)
10.1038/sj.ijo.0802173
When oral agents fail: practical barriers to starting insulin
M. Korytkowski (2002)
10.1016/J.DIABRES.2004.03.003
Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes.
K. Rašlová (2004)
10.2337/DIACARE.24.4.758
Combination therapies with insulin in type 2 diabetes.
H. Yki–Järvinen (2001)
10.2337/DIACARE.29.04.06.DC05-0053
Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study.
M. Peyrot (2005)
10.2337/dc08-9025
Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy
D. Nathan (2009)
10.1111/j.1464-5491.2006.01862.x
Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes
K. Kølendorf (2006)
10.1111/j.1464-5491.2005.01545.x
Comparison of three multiple injection regimens for Type 1 diabetes: morning plus dinner or bedtime administration of insulin detemir vs. morning plus bedtime NPH insulin
T. Pieber (2005)
10.2337/dc07-2052
Diabetes Care: Moving (a Little) in the Winds of Change
V. Fonseca (2008)
10.1016/S0149-2918(04)90072-0
Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen.
D. Russell-Jones (2004)
10.1007/s00125-007-0911-x
A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes
J. Rosenstock (2007)
10.1016/J.CLINTHERA.2006.10.020
Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes.
A. Philis-Tsimikas (2006)
10.2337/DIACARE.26.3.590
Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart.
P. Vague (2003)
10.1056/NEJM199309303291401
The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long‐Term Complications in Insulin‐Dependent Diabetes Mellitus
D. Nathan (1993)
10.1111/j.1463-1326.2007.00756.x
Towards peakless, reproducible and long‐acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies
T. Heise (2007)
10.2337/DIACARE.22.12.1956
Eating habits, body weight, and insulin misuse. A longitudinal study of teenagers and young adults with type 1 diabetes.
K. Bryden (1999)
10.2337/dc06-1738
The Effect of Glucose Variability on the Risk of Microvascular Complications in Type 1 Diabetes
(2007)
10.1016/j.pcd.2008.01.005
Initiating insulin in primary care--the role of modern premixed formulations.
R. Ligthelm (2008)
10.1002/PDI.568
Diabetes service provision in primary care: a baseline survey in a city primary care trust (PCT)
A. Farooqi (2004)
10.1185/030079908X260835
Safety and efficacy of insulin detemir basal-bolus therapy in type 1 diabetes patients: 14-week data from the European cohort of the PREDICTIVE study
A. Dornhorst (2008)
10.2337/dc08-0332
Comparison of Once- Versus Twice-Daily Administration of Insulin Detemir, Used With Mealtime Insulin Aspart, in Basal-Bolus Therapy for Type 1 Diabetes
J. Le Floch (2009)
10.1177/0145721706294259
Insulin Treatment and the Problem of Weight Gain in Type 2 Diabetes
C. Carver (2006)
10.1111/j.1463-1326.2004.00363.x
Insulin detemir used in basal‐bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin
I. D. De Leeuw (2005)
10.2337/DIACARE.27.5.1081
Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial.
P. Home (2004)
10.1016/S0084-3741(08)70010-6
A 26-Week, Randomized, Parallel, Treat-to-Target Trial Comparing Insulin Detemir With NPH Insulin as Add-On Therapy to Oral Glucose-Lowering Drugs in Insulin-Naïve People With Type 2 Diabetes
L. Kennedy (2007)
10.1111/j.1463-1326.2007.00816.x
Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal‐only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14‐week follow‐up data from PREDICTIVE™
A. Dornhorst (2008)
10.1016/J.CLINTHERA.2007.07.004
Importance of observational studies in clinical practice.
R. Ligthelm (2007)
10.2337/diacare.17.10.1178
Insulin Omission in Women With IDDM
W. Polonsky (1994)
10.2337/db08-1084
The Barrier of Hypoglycemia in Diabetes
P. Cryer (2008)
10.2337/dc06-1594
The Effect of Glucose Variability on the Risk of Microvascular Complications in Type 1 Diabetes
L. Monnier (2007)
10.1111/j.1742-1241.2007.01316.x
Safety and efficacy of insulin detemir in clinical practice: 14‐week follow‐up data from type 1 and type 2 diabetes patients in the PREDICTIVETM European cohort
A. Dornhorst (2007)
10.1007/s00125-008-1157-y
Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy
D. Nathan (2008)
10.1111/j.1463-1326.2006.00677.x
PREDICTIVE™– a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort
H. Lüddeke (2007)
Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group.
R. Turner (1998)
10.1007/s00125-004-1365-z
Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with Type 1 diabetes
K. Hermansen (2004)
10.2337/DIACARE.28.11.2673
Resistance to Insulin Therapy Among Patients and Providers Results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study
M. Peyrot (2005)



This paper is referenced by
10.1016/j.medcli.2012.03.004
[Hypoglycemia in older patients with diabetes].
Jorge Manzarbeitia Arambarri (2012)
Predictors and Consequences of Severe Hypoglycemia in Adults with Diabetes - A Systematic Review of the Evidence
H. Bloomfield (2012)
10.1055/s-0034-1383646
Are insulin analogues detemir or glulisine used preferentially in overweight/obese subjects? A German multicentre analysis of 38560 type 2 diabetic patients from the DPV registry.
B. Bohn (2014)
10.18865/ed.27.1.45
Insulin Detemir in Combination with Oral Antidiabetic Drugs Improves Glycemic Control in Persons with Type 2 Diabetes in Near East Countries: Results from the Lebanese Subgroup.
A. Echtay (2017)
10.1007/s12325-015-0245-x
Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study
J. Gautier (2015)
10.1007/s00125-011-2055-2
Chronic insulin therapy reduces adipose tissue macrophage content in LDL-receptor-deficient mice
J. Yoon (2011)
Willingness-to-Pay for a New Pharmaceutical : Is it Worth the Money ? Whose Money ?
Michèle Sennhauser (2010)
Современные базальные инсулины: продолжение истории или начало новой эры?
I. Dedov (2015)
10.1016/j.ijbiomac.2013.03.009
A newly identified polysaccharide from Ganoderma atrum attenuates hyperglycemia and hyperlipidemia.
Ke-Xue Zhu (2013)
10.1517/14656566.2011.626766
Improved glycemic control with weight loss and a low risk of hypoglycemia with insulin detemir: insights from the Italian cohort of the PREDICTIVE study after 6-month observation in type 2 diabetic subjects
G. Perriello (2011)
10.7365/JHPOR.2014.2.9
Risk of Severe hypoglycaemia for Various Treatment Regimens - A Systematic Review and Meta-analysis of Observational Studies
M. Jakubczyk (2014)
10.1007/s11892-017-0965-1
Reporting Severe Hypoglycemia in Type 1 Diabetes: Facts and Pitfalls
U. Pedersen-Bjergaard (2017)
10.1111/j.1464-5491.2012.03580.x
Audit of insulin detemir in pregnancy: a retrospective case series
V. V. Shenoy (2012)
10.2165/11470200-000000000-00000
Insulin Detemir
G. Keating (2012)
10.1007/S40275-014-0010-9
Ist ein neues Arzneimittel sein Geld wert? Wessen Geld? – Bewertung eines neuen Diabetes-Präparats mit Hilfe eines Discrete-Choice-Experiments
Michèle Sennhauser (2013)
10.1016/J.MEDCLI.2012.03.004
Hipoglucemia en ancianos con diabetes
J. M. Arámbarri (2012)
10.1007/s11606-011-1849-8
Interventions to Improve Veterans’ Access to Care: A Systematic Review of the Literature
Shannon M. Kehle (2011)
[Screening for subclinical complications in children and adolescents with type 1 diabetes: experience acquired in Brussels].
H. Dorchy (2010)
10.11648/J.IJDE.20190403.11
Cost Change After Initiating Basal Insulin for 6 Months in Patients with Type 2 Diabetes: A Registry Study in China
Dong-shan Zhu (2019)
10.1185/03007995.2011.630998
Insulin analogues: how observational studies provide key insights into management of patients with type 2 diabetes mellitus
R. Ligthelm (2011)
10.1186/s12902-015-0052-z
Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis
M. Czech (2015)
Semantic Scholar Logo Some data provided by SemanticScholar