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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00726674
First received: July 30, 2008
Last updated: March 7, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Decrease in HbA1c level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type II diabetes.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726674

Locations
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nurit Tweezer-Zaks Sanofi
  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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014