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

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT00726674
• Lead Sponsor: Sanofi

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study Start: 2008-08
• Study First Posted: 2008-08-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1229

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in HbA1c level	6 months

Secondary Outcome Measures

Name	Time	Method
Safety measures	7 months

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇮🇱 Natanya, Israel