Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565162
• Other study ID #: HOE901_4041
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2007
• Last updated: August 22, 2008
• Start date: November 2003
• Est. completion date: June 2005

Study information

• Verified date: August 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin Glargine
Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.

Locations

Country	Name	City	State
Finland	Sanofi-Aventis	Helsinki
Netherlands	Sanofi-Aventis	Amsterdam
Sweden	Sanofi-Aventis	Stockholm
United Kingdom	Sanofi-Aventis	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Finland,  Netherlands,  Sweden,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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