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Completed

NCT Number: NCT00726674

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

Treatment of diabetes mellitus type II with basal insulin, for patients treated in Clalit outpatient clinics that are not adequately controlled with current treatment.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sanofi-Aventis Administrative Office

Netanya, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Decrease in HbA1c level

    Time frame: 6 months

Secondary outcomes

  1. Safety measures

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Lantus for Diabetic Patients Treated in Clalit Outpatient Clinics

Acronym: Lapas II

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 1, 2008
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.