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LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00423215
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : June 15, 2009
Sponsor:
Information provided by:
Sanofi

Brief Summary:
The objective of this protocol is to confirm the efficacy and safety profile of Lantus in every day medical practice, in type 2 diabetic patients, have been treated with any other insulin but who did not reach the target of A1c = 7%.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Insulin glargine (LANTUS)

Study Type : Observational
Actual Enrollment : 1007 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Therapeutic Observational Evaluation of the Efficacy and Safety Profile of Lantus in Everyday Medical Practice in Type 2 Diabetes Mellitus Patients, Who Start Receiving Lantus - Treated With Any Other Insulin, With A1c>7%
Study Start Date : March 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with Type II diabetes Drug: Insulin glargine (LANTUS)

The patients will receive Lantus administered by subcutaneous injection, once daily at any time but at the same time each day.

Treatment duration: 4 months.




Primary Outcome Measures :
  1. Measure of Glycolysated Haemoglobin (HbA1c) level reduction [ Time Frame: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks) ]

Secondary Outcome Measures :
  1. Measure of Fasting Blood Glucose (FBG) level reduction [ Time Frame: Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks) ]
  2. Investigator assessment [ Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks) ]
  3. Insulin dose [ Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks) ]
  4. Patient's satisfaction [ Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Type II Diabetes
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus,
  • Having been treated with any other insulin, but who did not reach the target of A1c=7%.
  • Ability and willingness to perform Self Monitoring Blood Glucose measurement

Exclusion Criteria:

  • Will follow the prescribing information (Summary of Product Characteristics).

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): NCT00423215


Locations
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nurit Tweezer-Zaks, M.D. Sanofi

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00423215     History of Changes
Other Study ID Numbers: HOE901_5062
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: June 15, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs