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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)

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ClinicalTrials.gov Identifier: NCT00700960
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type : Observational
Actual Enrollment : 2745 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on Efficacy on Glycaemic Control of Slow-acting Insulin Analogue in Type 2 Diabetes
Study Start Date : June 2007
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Drug: insulin detemir
initiation of an long acting insulin treatment in association with OAD at the discretion of the physician/diabetologist



Primary Outcome Measures :
  1. HbA1c [ Time Frame: After 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700960


Locations
France
Novo Nordisk Investigational Site
Paris La Défense, France, 92936
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00700960     History of Changes
Other Study ID Numbers: NN304-1859
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs