Observational Study to Observe the Safety of Levemir® Treatment in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00735501
First received: August 13, 2008
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

This observational study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in subjects with type 2 diabetes during Levemir® treatment.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety of Levemir® (Insulin Detemir) Treatment in Patients With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: After 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of all hypoglycaemic events [ Time Frame: at 12 weeks and 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of all adverse drug reactions [ Time Frame: after 12 and 26 weeks ] [ Designated as safety issue: Yes ]
  • HbA1c [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Variability in fasting plasma glucose (FPG) values and average FPG levels at visits [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
  • Weight changes [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 314
Study Start Date: March 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation
Other Name: Levemir®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients aged 18 or above, with type 2 diabetes, who together with their physician, have decided to switch to Levemir® from human basal insulin treatment

Criteria

Inclusion Criteria:

  • Any patient with type 2 diabetes
  • Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin)
  • Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products.
  • Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months
  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: NCT00735501

Locations
Denmark
Copenhagen S, Denmark, 2300
Sweden
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Erik Christiansen Novo Nordisk Scandinavia AB
Study Director: Jakob Larsen Novo Nordisk Scandinavia AS
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00735501     History of Changes
Other Study ID Numbers: NN304-1938
Study First Received: August 13, 2008
Last Updated: August 12, 2014
Health Authority: Denmark: Danish Medicines Agency
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014