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

Study Overview
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Brief Summary
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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
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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

Official Title
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Lantus for Diabetic Patients Treated in Clalit Outpatient Clinics

Conditions
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Type 2 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type II Diabetic patients HbA1c >8.0% (result from preceding 4 months) Written informed consent Life expectancy of at least 1 year. Patients' agree to discontinue current long acting insulin (if applicable). Patients who according to their GP are eligible to the study. Exclusion Criteria: Type I diabetes Pregnancy and\or lactation. Allergy to basal insulin Patients suffering from a disease that requires repeated hospitalizations E.g.: severe CHF, sever renal failure, active malignancy. Patients who are not able to give consent. 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in HbA1c level |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes HbA1C