A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar With Type 2 Diabetes Mellitus (AT-LANTUS)

August 30, 2010 updated by: Sanofi

A Multicentre, Multinational, Randomised, Open Study to Establish the Optimal Method for Initiating and Maintaining Lantus® (Insulin Glargine) Therapy Based on a Comparison of Two Treatment Algorithms to Determine Optimal Metabolic Outcomes, Safety, and Satisfaction in Subjects With Type 2 Diabetes Mellitus.

Primary objective:

  • To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia.

Secondary objectives:

  • To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia.
  • To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms.
  • To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment.
  • To obtain safety data on the use of insulin glargine in each treatment algorithm.
  • To measure change in subject weight and insulin dose between baseline and end of treatment.
  • To determine subject quality of life and treatment satisfaction (sub-study)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

7376

Phase

  • Phase 4

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:

  • Subjects with Type 2 Diabetes Mellitus,
  • Subjects on antidiabetic treatment (oral and/or insulin therapy) for > 6 months,
  • Subjects who require a basal long-acting insulin for the control of hyperglycaemia,
  • HbA1c values > 7.0% and < 12 %,
  • BMI < 40 kg/m².

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
Incidence of severe hypoglycaemia

Secondary Outcome Measures

Outcome Measure
Safety data
Incidence of any hypoglycaemia
Incidence of symptomatic hypoglycaemia
Incidence of nocturnal hypoglycaemia
Incidence of asymptomatic hypoglycaemia
Adjusted mean change in Hb1Ac (%)
Adjusted mean change in fasting blood glucose (FBG) (mg/dl)
Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl)
Adjusted mean change in mean daily blood glucose (MBG) (mg/dl)
% of subjects at v12 with Hb1Ac < or = 6.5 %
% of subjects at v12 with Hb1Ac < or = 7.0 %
% of subjects at v12 with FBG < or = 100 mg/dl
Weight change (kg)
Change in insulin glargine dose v2 - v12 (IU)
Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire

Collaborators and Investigators

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

Sponsor

Sanofi

Investigators

  • Study Director: Patrick Sinnassamy, MD, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2002

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

November 14, 2006

First Submitted That Met QC Criteria

November 14, 2006

First Posted (Estimate)

November 15, 2006

Study Record Updates

Last Update Posted (Estimate)

August 31, 2010

Last Update Submitted That Met QC Criteria

August 30, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_3504

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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