Observational Study Describing Conditions for Administering Slow-acting Insulin Analogue With Oral Antidiabetic Agents in Type 2 Diabetes on Blood Glucose Control

NCT00700960 | Completed

• 1 other identifier: NN304-1859
• Study Type: observational
• Target: 2,745
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in Europe. The aim of this observational study is to describe the conditions for the concomitant administration of a slow-acting insulin analogue with oral antidiabetics (OADs) in order to improve blood glucose control in type 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  After 3 months

Study Arms (1)

A

Drug: insulin detemir

Interventions

insulin detemir DRUG

initiation of an long acting insulin treatment in association with OAD at the discretion of the physician/diabetologist

A

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes

You may qualify if:

• Type 2 diabetes
• HbA1c level greater than 7% despite treatment with two (or three) oral antidiabetic drugs (OADs) at an optimal dose level
• Patient agreeing to take part in the study and capable of completing a self-questionnaire.

You may not qualify if:

• Hypersensitivity to insulin or to one of the excipients
• Treatment with insulin for at least 6 months
• Participant in a clinical trial for diabetes on entry into the observational study

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Paris La Défense, 92936, France

Location

Related Publications (1)

• Verges B, Brun JM, Tawil C, Alexandre B, Kerlan V. Strategies for insulin initiation: insights from the French LIGHT observational study. Diabetes Metab Res Rev. 2012 Jan;28(1):97-105. doi: 10.1002/dmrr.1288.

  PMID: 22218757 RESULT

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: June 18, 2008
• First Posted: June 19, 2008
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

FR (1)