Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: Insulin Glargine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Sanni Lahdenpera, Study Director, Affiliation: Sanofi-Aventis
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: Treatment, Randomized, Open Label, Parallel Assignment
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
Starting date: November 2003
Ending date: June 2005
Last updated: November 28, 2007
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