Basal Insulin for Type 2 Diabetes Patients Treated in Outpatient Clalit Clinics

Type 2 Diabetes Clinical Trial

— Lapas II  

Official title:

Lantus for Diabetic Patients Treated in Clalit Outpatient Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726674
• Other study ID #: LANTU_L_04137
• Status: Completed
• Phase: N/A
• First received: July 30, 2008
• Last updated: March 7, 2012
• Start date: August 2008
• Est. completion date: January 2012

Study information

• Verified date: March 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Treatment of diabetes mellitus type II with basal insulin, for patients treated in Clalit outpatient clinics that are not adequately controlled with current treatment.

Description:

Patients with diabetes treated in outpatient clinics will be recruited by their primary care physician. Recruitment period will be 3 months per center and each patient will be followed for 7 months Diabetes specialists will be responsible for 50-65 primary care physicians. The specialists will advise and direct the primary care physician through the whole study period.

The study protocol includes patients treated with different types of non short- acting insulin. Insulin Lantus (including dose) will be started by the primary physician, if needed after consulting the Diabetes Specialist. The treatment should follow the study protocol.

Patients will have 3 pre-scheduled visits in their clinic: 1. At the beginning of study. 2. After 3 months. 3. At study end (after 6 month). An additional telephone contact will take place 1 month after last visit. to evaluate adherence to therapy Data collecting: Data including HbA1c, FPG,current diabetic treatment, dose of insulin Lantus, and relevant additional diseases\complaints will be collected at each visit. Additional information as demographic data, medical history will be collected at beginning of study.

Safety: Hypoglycaemic episodes will be recorded

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1229
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Type II Diabetic patients

2. HbA1c >8.0% (result from preceding 4 months)

3. Written informed consent

4. Life expectancy of at least 1 year.

5. Patients' agree to discontinue current long acting insulin (if applicable).

6. Patients who according to their GP are eligible to the study.

Exclusion Criteria:

1. Type I diabetes

2. Pregnancy and\or lactation.

3. Allergy to basal insulin

4. Patients suffering from a disease that requires repeated hospitalizations E.g.:

severe CHF, sever renal failure, active malignancy.

5. Patients who are not able to give consent.

6. Patients face difficulties in mobility and/or verbal communication with the treating physician.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
Israel	Sanofi-Aventis Administrative Office	Natanya

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in HbA1c level		6 months	No
Secondary	Safety measures		7 months	No