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Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

NCT ID: NCT00565162

Last Updated: 2008-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-06-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Insulin Glargine

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

Intervention Type DRUG

Other Intervention Names

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Lantus

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Principal Investigators

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Sanni Lahdenpera

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Helsinki, , Finland

Site Status

Sanofi-Aventis

Amsterdam, , Netherlands

Site Status

Sanofi-Aventis

Stockholm, , Sweden

Site Status

Sanofi-Aventis

Leicester, , United Kingdom

Site Status

Countries

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Finland Netherlands Sweden United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 17384341 (View on PubMed)

Other Identifiers

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HOE901_4041

Identifier Type: -

Identifier Source: org_study_id