Observational Study in Type 2 Diabetics Treated by an Intensive Insulin Treatment of Levemir®

NCT00806897 | Completed

• 1 other identifier: NN304-3701
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Europe. The aim of this observational study is to gain practical experience with once daily Levemir® administration in type 2 diabetes patients who were previously treated with NPH insulins (e.g. Protaphane®) as basal insulin as part of their IIT under normal clinical practice conditions in Lithuania

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline

  at 24 weeks

Secondary Outcomes (1)

• Change in body weight

  at 12 weeks/24weeks

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemir DRUG

Effectiveness data collection in connection with the use of the drug Levemir® in daily clinical practice.

Also known as: Levemir®, NN304

A

Eligibility Criteria

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

Study Population

Diabetic subjects from specialists' (diabetologists, internists) care who are treated with intensive insulin treatment by prescription in line with governing prescribing rules. At baseline subjects are treated with IIT containing NPH as basal insulin.

You may qualify if:

• Type 2 diabetic subjects on intensive insulin treatment (IIT)
• Eligibility for once daily insulin detemir administration
• Informed consent obtained before any observation-related activities

You may not qualify if:

• Known or suspected allergy to insulin detemir
• Subjects previously enrolled in the observation
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Vilnius, 01112, Lithuania

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

LI (1)