NCT00565162

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started Nov 2003

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2007

Completed
Last Updated

August 25, 2008

Status Verified

August 1, 2008

First QC Date

November 28, 2007

Last Update Submit

August 22, 2008

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Insulin GlargineDRUG

Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.

Also known as: Lantus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 %).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sanofi-Aventis

Helsinki, Finland

Location

Sanofi-Aventis

Amsterdam, Netherlands

Location

Sanofi-Aventis

Stockholm, Sweden

Location

Sanofi-Aventis

Leicester, United Kingdom

Location

Related Publications (1)

  • Yki-Jarvinen H, Juurinen L, Alvarsson M, Bystedt T, Caldwell I, Davies M, Lahdenpera S, Nijpels G, Vahatalo 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. doi: 10.2337/dc06-1357. Epub 2007 Mar 23.

    PMID: 17384341BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Sanni Lahdenpera

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 29, 2007

Study Start

November 1, 2003

Study Completion

June 1, 2005

Last Updated

August 25, 2008

Record last verified: 2008-08

Locations

NL(1)SE(1)GB(1)FI(1)