Observational Study Describing Conditions for Intensification of Insulin Therapy in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00712478

Purpose

This study is conducted in Europe. The aim of this observational study is to determine diabetes control improvement, during the third month of follow-up after insulin intensification to at least 3 daily insulin injections, in assessing the proportion of uncontrolled fasting and postprandial glycaemia values recorded on a diary.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: insulin

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections in Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements [ Time Frame: After 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements [ Time Frame: After first 2 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1200
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Men and women aged 40 years old and more with type 2 diabetes

Criteria

Inclusion Criteria:

Type 2 diabetes patients
Treatment with two insulin daily injections and needing insulin intensification regimen to at least three daily injections
HbA1c greater than or equal to 8.0%

Exclusion Criteria:

Patients not performing glycaemia self-measurements
Secondary diabetes
Requirement of or use of an insulin pump
Treatment with corticoids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712478

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

France
	Recruiting
Paris La Défense, France, 92936

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Nathalie GIAUQUE, MD

Novo Nordisk Pharmaceutique SAS

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:	BIASP-1866
Study First Received:	June 30, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00712478
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

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 January 14, 2009