Clinical trial NCT00659295: Observational Study to Evaluate the Safety of Levemir® in Diabetes
Official title: A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study: Predictable Results and Experience in Diabetes Through Intensification and Control to Target: an International Variability Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 51170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® (insulin detemir) as new treatment and as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions.

Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.


Eligibility criteria: Inclusion Criteria:

* Age according to approved label in each country and physician discretion
* Type 1 or 2 diabetes
* Recently started treatment with insulin detemir at the discretion of the investigator. Before initiation of insulin detemir they should not have been treated with insulin
* Selection at the discretion of the physician

Exclusion Criteria:

* Current treatment with Levemir® (insulin detemir)
* Previously enrolled in the study
* Hypersensitivity to Levemir® (insulin detemir)

Primary outcomes:
measure: Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
timeFrame: Months 0-12
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Novo Nordisk Investigational Site
city: Prague
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Copenhagen S
country: Denmark
facility: Novo Nordisk Investigational Site
city: Espoo
country: Finland
facility: Novo Nordisk Investigational Site
city: Paris La défense cedex
country: France
facility: Novo Nordisk Investigational Site
city: Vouliagment
country: Greece
facility: Novo Nordisk Investigational Site
city: Dublin 2
country: Ireland
facility: Novo Nordisk Investigational Site
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Crawley
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Dornhorst A, Luddeke HJ, Honka M, Ackermann RW, Merilainen M, Gallwitz B, Sreenan S; PREDICTIVE Study Group. 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. Curr Med Res Opin. 2008 Feb;24(2):369-76. doi: 10.1185/030079908x260835.
citation: Honka M. [Results of the PREDICTIVE project in the Czech Republic]. Vnitr Lek. 2008 Apr;54(4):361-7. Czech.
citation: Dornhorst A, Luddeke HJ, Koenen C, Merilainen M, King A, Robinson A, Sreenan S; PREDICTIVE Study Group. 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. Diabetes Obes Metab. 2008 Jan;10(1):75-81. doi: 10.1111/j.1463-1326.2007.00816.x. Epub 2007 Nov 22.
citation: Dornhorst A, Luddeke HJ, Sreenan S, Koenen C, Hansen JB, Tsur A, Landstedt-Hallin L. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort. Int J Clin Pract. 2007 Mar;61(3):523-8. doi: 10.1111/j.1742-1241.2007.01316.x.
citation: Dornhorst A, Luddeke HJ, Sreenan S, Kozlovski P, Hansen JB, Looij BJ, Meneghini L; PREDICTIVE Study Group. Insulin detemir improves glycaemic control without weight gain in insulin-naive patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract. 2008 Apr;62(4):659-65. doi: 10.1111/j.1742-1241.2008.01715.x.
citation: Luddeke HJ, Sreenan S, Aczel S, Maxeiner S, Yenigun M, Kozlovski P, Gydesen H, Dornhorst A; PREDICTIVE Study Group. 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. Diabetes Obes Metab. 2007 May;9(3):428-34. doi: 10.1111/j.1463-1326.2006.00677.x.
citation: Sreenan S, Virkamaki A, Zhang K, Hansen JB; PREDICTIVE study group. Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE study. Int J Clin Pract. 2008 Dec;62(12):1971-80. doi: 10.1111/j.1742-1241.2008.01939.x.
citation: Palmer JL, Goodall G, Nielsen S, Kotchie RW, Valentine WJ, Palmer AJ, Roze S. Cost-effectiveness of insulin aspart versus human soluble insulin in type 2 diabetes in four European countries: subgroup analyses from the PREDICTIVE study. Curr Med Res Opin. 2008 May;24(5):1417-28. doi: 10.1185/030079908x297295. Epub 2008 Apr 8.
citation: Valentine WJ, Goodall G, Aagren M, Nielsen S, Palmer AJ, Erny-Albrecht K. Evaluating the cost-effectiveness of therapy conversion to insulin detemir in patients with type 2 diabetes in Germany: a modelling study of long-term clinical and cost outcomes. Adv Ther. 2008 Jun;25(6):567-84. doi: 10.1007/s12325-008-0069-z.
citation: Hermansen K, Lund P, Clemmensen K, Breum L, Kleis Moller M, Mette Rosenfalck A, Christiansen E; Danish PREDICTIVE study group. 3-Month Results from Denmark within the Globally Prospective and Observational Study to Evaluate Insulin Detemir Treatment in Type 1 and Type 2 Diabetes: The PREDICTIVE Study. Rev Diabet Stud. 2007 Summer;4(2):89-97. doi: 10.1900/RDS.2007.4.89. Epub 2007 Aug 10.
citation: Fontaine P, Gin H, Pinget M, Thivolet C, Hanaire H, Robert JJ, Marre M, Venkatanarasimhachar S. Effect of insulin detemir dose frequency on clinical outcomes in patients with diabetes in PREDICTIVE. Adv Ther. 2009 May;26(5):535-51. doi: 10.1007/s12325-009-0033-6. Epub 2009 Jun 2.
citation: Hermansen K, Dornhorst A, Sreenan S. Observational, open-label study of type 1 and type 2 diabetes patients switching from human insulin to insulin analogue basal-bolus regimens: insights from the PREDICTIVE study. Curr Med Res Opin. 2009 Nov;25(11):2601-8. doi: 10.1185/03007990903262885.
citation: Niskanen L, Virkamaki A, Hansen JB, Saukkonen T. Fasting plasma glucose variability as a marker of nocturnal hypoglycemia in diabetes: evidence from the PREDICTIVE study. Diabetes Res Clin Pract. 2009 Nov;86(2):e15-8. doi: 10.1016/j.diabres.2009.08.005. Epub 2009 Sep 10.
citation: Yenigun M, Honka M. Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the PREDICTIVE study. Int J Clin Pract. 2009 Mar;63(3):425-32. doi: 10.1111/j.1742-1241.2008.01973.x.
citation: Perriello G, Caputo S, De Pergola G, Di Carlo A, Grassi G, Lapolla A, Pata P, Solerte SB, Zaccardi F. 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. Expert Opin Pharmacother. 2011 Nov;12(16):2449-55. doi: 10.1517/14656566.2011.626766.
citation: Yang L, Christensen T, Sun F, Chang J. Cost-effectiveness of switching patients with type 2 diabetes from insulin glargine to insulin detemir in Chinese setting: a health economic model based on the PREDICTIVE study. Value Health. 2012 Jan-Feb;15(1 Suppl):S56-9. doi: 10.1016/j.jval.2011.11.018.
citation: Sreenan S, Andersen M, Thorsted BL, Wolden ML, Evans M. Increased Risk of Severe Hypoglycemic Events with Increasing Frequency of Non-severe Hypoglycemic Events in Patients with Type 1 and Type 2 Diabetes. Diabetes Ther. 2014 Dec;5(2):447-58. doi: 10.1007/s13300-014-0075-x. Epub 2014 Jul 15.