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 A/S
ClinicalTrials.gov Identifier:
NCT00700960
First received: June 18, 2008
Last updated: June 26, 2012
Last verified: June 2012
  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:


Further study details as provided by Novo Nordisk A/S:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700960

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

Additional Information:
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 July 28, 2014