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LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00423215
First received: January 17, 2007
Last updated: June 12, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Insulin glargine (LANTUS)
 Phase 4

Study Type: Observational
Study Design: 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%

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Investigator assessment [ Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks) ] [ Designated as safety issue: No ]
  • Insulin dose [ Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks) ] [ Designated as safety issue: No ]
  • Patient's satisfaction [ Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks) ] [ Designated as safety issue: No ]

Enrollment: 1007
Study Start Date: March 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423215

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00423215     History of Changes
Other Study ID Numbers: HOE901_5062
Study First Received: January 17, 2007
Last Updated: June 12, 2009
Health Authority: Israel: Ministry of Health

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 May 22, 2013