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
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, see Learn About Clinical Studies.

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
Insulin, Globin Zinc
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014