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

NCT00735501 | Completed

• 1 other identifier: NN304-1938
• Study Type: observational
• Target: 314
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse drug reactions, including major hypoglycaemic events

  After 26 weeks

Secondary Outcomes (5)

• Number of all hypoglycaemic events

  at 12 weeks and 26 weeks

• Number of all adverse drug reactions

  after 12 and 26 weeks

• HbA1c

  at 12 and 26 weeks

• Variability in fasting plasma glucose (FPG) values and average FPG levels at visits

  at 12 and 26 weeks

• Weight changes

  at 12 and 26 weeks

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemir DRUG

Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation

Also known as: Levemir®

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Unknown Facility

Copenhagen S, 2300, Denmark

Location

Unknown Facility

Stockholm, 182 88, Sweden

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 15, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

DK (1); SE (1)