Basal Insulin for Type 2 Diabetes Patients Treated in Outpatient Clalit Clinics (Lapas II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00726674
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):

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.

Condition or disease
Type 2 Diabetes

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 Type : Observational
Actual Enrollment : 1229 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lantus for Diabetic Patients Treated in Clalit Outpatient Clinics
Study Start Date : August 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Decrease in HbA1c level [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety measures [ Time Frame: 7 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type II diabetes.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00726674

Sanofi-Aventis Administrative Office
Natanya, Israel
Sponsors and Collaborators
Study Director: Nurit Tweezer-Zaks Sanofi

Responsible Party: Sanofi Identifier: NCT00726674     History of Changes
Other Study ID Numbers: LANTU_L_04137
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Sanofi:
Diabetes HbA1C

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases