Skip to main content
OpenTrials
Completed

NCT Number: NCT00423215

LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

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%.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis Administrative Office

Netanya, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin Glargine (Lantus)

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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%

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 18, 2007
Registry last updated
Jun 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.