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