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Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus

Intervention: Insulin Glargine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Sanni Lahdenpera, Study Director, Affiliation: Sanofi


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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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 %.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Sanofi-Aventis, Helsinki, Finland

Sanofi-Aventis, Amsterdam, Netherlands

Sanofi-Aventis, Stockholm, Sweden

Sanofi-Aventis, Leicester, United Kingdom

Additional Information

Related 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.

Starting date: November 2003
Last updated: August 22, 2008

Page last updated: August 23, 2015

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