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
  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:


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

ClinicalTrials.gov processed this record on September 18, 2014