LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

December 4, 2009 updated by: Sanofi

The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients

The rationale of the study is to determine:

  • the first dose and the titration of basal insulin
  • the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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

  • Hungary
      • Budapest, Hungary
        • Sanofi-Aventis

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
  • BMI >25 kg/m2 , <30 kg/m2
  • HbA1c value >7.0%, <9.0% within one month

Exclusion Criteria:

  • Type 1 Diabetes Mellitus
  • Known malignancy
  • Drug or alcohol abuse
  • Severe liver disease
  • Renal failure (se Creatinine > 150 micro mol/l)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HgbA1c measurement

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: László Erős, MD, 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

September 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

July 7, 2006

First Submitted That Met QC Criteria

July 7, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4059

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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