Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00565162
First received: November 28, 2007
Last updated: August 22, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: Insulin Glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 %. [ Time Frame: HbA1c values at visits 1, 2, 5 and 10 ]

Enrollment: 124
Study Start Date: November 2003
Study Completion Date: June 2005
Intervention Details:
    Drug: Insulin Glargine
    Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.
    Other Name: Lantus
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565162

Locations
Finland
Sanofi-Aventis
Helsinki, Finland
Netherlands
Sanofi-Aventis
Amsterdam, Netherlands
Sweden
Sanofi-Aventis
Stockholm, Sweden
United Kingdom
Sanofi-Aventis
Leicester, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Sanni Lahdenpera Sanofi
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00565162     History of Changes
Other Study ID Numbers: HOE901_4041
Study First Received: November 28, 2007
Last Updated: August 22, 2008
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014