LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

NCT00423215 | Completed

• 1 other identifier: HOE901_5062
• Study Type: observational
• Target: 1,007
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Measure of Glycolysated Haemoglobin (HbA1c) level reduction

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

Secondary Outcomes (4)

• Measure of Fasting Blood Glucose (FBG) level reduction

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

• Investigator assessment

  At the end of the study (i.e. 4 months +/- 2 weeks)

• Insulin dose

  At the end of the study (i.e. 4 months +/- 2 weeks)

• Patient's satisfaction

  At the end of the study (i.e. 4 months +/- 2 weeks)

Study Arms (1)

Patients with Type II diabetes

Drug: Insulin glargine (LANTUS)

Interventions

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.

Patients with Type II diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Type II Diabetes

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Netanya, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nurit Tweezer-Zaks, M.D.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: March 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 15, 2009

Record last verified: 2009-06

Locations

IL (1)