ClinicalTrials.gov
ClinicalTrials.gov Menu

Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00565162
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : August 25, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Insulin Glargine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2003
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Insulin Glargine
    Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.
    Other Name: Lantus


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00565162     History of Changes
Other Study ID Numbers: HOE901_4041
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: August 25, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs