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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00659295
First received: April 10, 2008
Last updated: August 15, 2014
Last verified: August 2014
  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:


Further study details as provided by Novo Nordisk A/S:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 26 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: 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: August 15, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Committee of Ethics in Research
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Ethics Committee
France: French National Agency for Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
India: Ministry of Health
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Ministry of Health, Labour and Welfare (MHLW)
South Korea: Korea Food and Drug Administration (KFDA)
Lebanon: Ministry of Public Health
Luxembourg: Le Gouvernement du Grand-Duché de Luxembourg
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Federal Ethics Committee
Saudi Arabia: Ministry of Health
Slovenia: Agency for Medicinal Products
South Africa: Medicines Control Council
Sweden: Medical Products Agency
Tunisia: Direction of Pharmacy and Medicines
Turkey: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory

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, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014