Observational Study Describing Conditions for Administering Slow-Acting Insulin Analogue With Oral Antidiabetic Agents in Type 2 Diabetes on Blood Glucose Control. - Full Text View

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.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00700960

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 Mellitus, Type 2	Drug: insulin detemir

MedlinePlus related topics:

Diabetes

Drug Information available for:

Insulin Insulin Detemir Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Observational Study on Efficacy on Glycaemic Control of Slow-Acting Insulin Analogue in Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: After 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	2745
Study Start Date:	June 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 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

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1859
First Received:	June 18, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00700960
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Insulin, Long-Acting

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008