Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00565162

First received: November 28, 2007

Last updated: August 22, 2008

Last verified: August 2008

History of Changes

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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 Diabetes Medicines Diabetes Type 2

Drug Information available for: Insulin human Insulin glargine

U.S. FDA Resources

Further study details as provided by Sanofi:

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.

Other Name: Lantus

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

Investigators

Study Director:

Sanni Lahdenpera

Sanofi

More Information

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.

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

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine

Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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