Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®

NCT00658099 | Completed

• 1 other identifier: NN304-1976
• Study Type: observational
• Target: 699
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in weight

  after 6 months of treatment

Secondary Outcomes (6)

• The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values

  after 6 months of treatment

• The incidence of hypoglycaemic events

  after 6 months of treatment

• Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints.

  after 6 months of treatment

• The general well-being by using the WHO-5 well-being questionnaire.

  after 6 months of treatment

• The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire

  after 6 months of treatment

Study Arms (2)

A

Drug: insulin detemir

B

Drug: insulin NPH

Interventions

insulin detemir DRUG

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

A

insulin NPH DRUG

Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation

B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes patiens failing on oral anti-diabetic agents

You may qualify if:

• Type 2 diabetes
• HbA1c greater than 7.0% and/or hypoglycaemia
• variable FBG and/or weight increase
• the selection of the subjects will be at the discretion of the participating physician

You may not qualify if:

• non-type 2 diabetes
• current treatment with Levemir® or Insulatard®
• hypersensitivity to Levemir® or Insulatard® or to any of the excipients
• women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bucharest, 010031, Romania

Location

Related Publications (1)

• Doina Catrinoiu; Effect of Once-Daily Detemir vs NPH Insulin on Body Weight and Metabolic Control When Added to OADs in Type 2 Diabetes; 2029-PO; 69th Scientific Sessions (2009); American Diabetes Association

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir; Insulin, Isophane

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: April 8, 2008
• First Posted: April 14, 2008
• Study Start: November 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

RO (1)