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

January 17, 2007
June 12, 2009
March 2006
May 2008   (final data collection date for primary outcome measure)
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 ]
HBA1C
Complete list of historical versions of study NCT00423215 on ClinicalTrials.gov Archive Site
  • 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 ]
FBG
Not Provided
Not Provided
 
LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus
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%.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with Type II Diabetes

Diabetes Mellitus, Type 2
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.

Patients with Type II diabetes
Intervention: Drug: Insulin glargine (LANTUS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1007
May 2008
May 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00423215
HOE901_5062
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Nurit Tweezer-Zaks, M.D. Sanofi
Sanofi
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP