Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

This study has been completed.

First Received: November 28, 2007 Last Updated: August 22, 2008 History of Changes

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00565162

Purpose

To introduce initiation of glargine insulin treatment in primary care based on a patient education program. To show and compare feasibility of group education to individual education program.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Insulin Glargine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating Lantus(Insulin Glargine) Therapy to Determine Metabolic and Economic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Superiority is based on observing clinically significant difference in glycaemic control (> than or = to 0,5 % HbA1c). Programs are defined as equally successful if the HbA1c differs less than 0,5 %. [ Time Frame: HbA1c values at visits 1, 2, 5 and 10 ]

Enrollment:	124
Study Start Date:	November 2003
Study Completion Date:	June 2005

Intervention Details:

Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Insulin-naive Type 2 Diabetes Mellitus subjects, aged ≥18 years and on stable oral anti-diabetic treatment for >6 months requiring basal long-acting insulin (HbA1c >7.5 % and <12.0 %).

Exclusion Criteria:

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565162

Locations

Finland
Sanofi-aventis
Helsinki, Finland
Netherlands
Sanofi-aventis
Amsterdam, Netherlands
Sweden
Sanofi-aventis
Stockholm, Sweden
United Kingdom
Sanofi-aventis
Leicester, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Sanni Lahdenpera

Sanofi-Aventis

More Information

Additional Information:

clinicalstudyresults.org This link exits the ClinicalTrials.gov site

Publications:

Yki-Järvinen H, Juurinen L, Alvarsson M, Bystedt T, Caldwell I, Davies M, Lahdenperä S, Nijpels G, Vähätalo M. Initiate Insulin by Aggressive Titration and Education (INITIATE): a randomized study to compare initiation of insulin combination therapy in type 2 diabetic patients individually and in groups. Diabetes Care. 2007 Jun;30(6):1364-9. Epub 2007 Mar 23.

Study ID Numbers:	HOE901_4041
Study First Received:	November 28, 2007
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00565162 History of Changes
Health Authority:	Finland: National Agency for Medicines

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 09, 2009