Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

Phase 4

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00565162
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study Completion: 2005-06
• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-28
• Study First Posted: 2007-11-29
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-22
• Last Update Posted: 2008-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 %).

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 %.	HbA1c values at visits 1, 2, 5 and 10

Trial Locations

Locations (1)

Sanofi-Aventis; 🇬🇧 Leicester, United Kingdom