Observational Study to Evaluate the Safety of Levemir® in Diabetes - Full Text View

Purpose

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.

Condition	Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2	Drug: insulin detemir

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1 Diabetes Type 2

Drug Information available for: Insulin human Insulin detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events [ Time Frame: Months 0-12 ] [ Designated as safety issue: No ]
The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.

Enrollment:	51170
Study Start Date:	June 2004
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Type 1 diabetes Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.	Drug: insulin detemir Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.
Type 2 diabetes Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.	Drug: insulin detemir Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659295

Show 26 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

M. V. Srishyla

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided by Novo Nordisk

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Niskanen L, Virkamäki 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. Epub 2009 Sep 10.

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. Epub 2009 Jun 2.

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.

Sreenan S, Virkamäki 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.

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00659295 History of Changes
Other Study ID Numbers:	NN304-1677
Study First Received:	April 10, 2008
Results First Received:	June 16, 2011
Last Updated:	July 20, 2011
Health Authority:	Denmark: Danish Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory India: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Russia: Federal Ethics Committee South Africa: Medicines Control Council South Korea: Korea Food and Drug Administration (KFDA) Sweden: Medical Products Agency Ireland: Irish Medicines Board Italy: Ethics Committee Japan: Ministry of Health, Labour and Welfare (MHLW) Belgium: Federal Agency for Medicines and Health Products Austria: Agency for Health and Food Safety Brazil: National Committee of Ethics in Research Czech Republic: State Institute for Drug Control Finland: Ethics Committee France: French National Agency for Health Israel: Ministry of Health Luxembourg: Le Gouvernement du Grand-Duché de Luxembourg Slovenia: Agency for Medicinal Products Tunisia: Direction of Pharmacy and Medicines Turkey: Ethics Committee Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases

Immune System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

Observational Study to Evaluate the Safety of Levemir® in Diabetes (PREDICTIVE™)