Basal Insulin for Type 2 Diabetes Patients Treated in Outpatient Clalit Clinics (Lapas II)
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Purpose
Treatment of diabetes mellitus type II with basal insulin, for patients treated in Clalit outpatient clinics that are not adequately controlled with current treatment.
| Condition |
|---|
|
Type 2 Diabetes |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Lantus for Diabetic Patients Treated in Clalit Outpatient Clinics |
- Decrease in HbA1c level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Safety measures [ Time Frame: 7 months ] [ Designated as safety issue: No ]
| Enrollment: | 1229 |
| Study Start Date: | August 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Type II diabetes.
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00726674 History of Changes |
| Other Study ID Numbers: | LANTU_L_04137 |
| Study First Received: | July 30, 2008 |
| Last Updated: | March 7, 2012 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Sanofi:
|
Diabetes HbA1C |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013