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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00700960
First received: June 18, 2008
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Efficacy on Glycaemic Control of Slow-acting Insulin Analogue in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: After 3 months ] [ Designated as safety issue: No ]

Enrollment: 2700
Study Start Date: June 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: insulin detemir
initiation of an long acting insulin treatment in association with OAD at the discretion of the physician/diabetologist

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with type 2 diabetes

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700960

Locations
France
Paris La Défense, France, 92936
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Sophie GONBERT, MD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700960     History of Changes
Other Study ID Numbers: NN304-1859
Study First Received: June 18, 2008
Last Updated: June 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 May 16, 2013