LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

June 12, 2009 updated by: Sanofi

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%

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1007

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Natanya, Israel
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Type II Diabetes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks)
Investigator assessment
Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks)
At the end of the study (i.e. 4 months +/- 2 weeks)
Insulin dose
Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks)
At the end of the study (i.e. 4 months +/- 2 weeks)
Patient's satisfaction
Time Frame: At the end of the study (i.e. 4 months +/- 2 weeks)
At the end of the study (i.e. 4 months +/- 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Nurit Tweezer-Zaks, M.D., Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

January 17, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

June 15, 2009

Last Update Submitted That Met QC Criteria

June 12, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_5062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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