Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control (LANTIT)

November 3, 2010 updated by: Sanofi

Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients

Primary objective:

  • To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients

Secondary objectives:

  • To assess the forced titration on physician and patient satisfaction
  • To evaluate the impact of training tools by means of patient profile

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • T2 insulin naïve patients
  • Patients whom their physician is considering initiation of Lantus treatment
  • Poor glycemic control 7,5 %10 %
  • T2 treatment with OADs more than 3 months
  • BMI<40 kg/m2

Exclusion Criteria:

  • Impaired renal function (Cr>2mg/dl or current renal dialysis)
  • Acute or chronic metabolic acidosis
  • Active liver disease or serum ALT or AST >2,5 than normal
  • History of hypoglycemia unawareness
  • Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
  • Pregnancy, breast feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Insulin glargine
Drug: Insulin glargine
The dose is titrated according to patient needs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c, FBG
Time Frame: after treatment end (6 months)
after treatment end (6 months)
Final dose
Time Frame: after treatment end (6 months)
after treatment end (6 months)
Number of dose adjustment
Time Frame: after treatment end (6 months)
after treatment end (6 months)
Time to dose titration
Time Frame: after treatment end (6 months)
after treatment end (6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Hypoglycemia
Time Frame: after treatment end (6 months)
after treatment end (6 months)
Noctural hypoglycemia
Time Frame: after treatment end (6 months)
after treatment end (6 months)
DTSQ
Time Frame: after treatment end (6 months)
after treatment end (6 months)
Physician Satisfaction Questionnaire
Time Frame: after treatment end (6 months)
after treatment end (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Zeynep Cetin, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

November 4, 2010

Last Update Submitted That Met QC Criteria

November 3, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LANTU_L_03502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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