Tulip Study: Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes

January 10, 2011 updated by: Sanofi

Testing the Usefulness of Lantus When Initiated Prematurely In Patients With Type 2 Diabetes

Primary objective:

The primary objective of this trial is:

  • To evaluate the efficacy of initiating Lantus in combination with oral antidiabetics drugs compared to oral antidiabetic treatment optimised by enhancing hygienic and dietary measures in type 2 diabetics whose blood glucose control is acceptable but not optimal on maximum oral treatment, based on the number of patients achieving a HbA1c value < 7% at the end of treatment.

Secondary objectives:

The secondary objectives of this trial are to compare between the two treatment groups:

  • The variation in HbA1c between baseline and end of trial.
  • The frequency of episodes of symptomatic hypoglycaemia (diurnal and nocturnal), severe hypoglycaemia (diurnal and nocturnal) and asymptomatic hypoglycaemia.
  • Mean blood glucose levels at different times of the day.
  • The variation in weight and lipid in each group between baseline and end of trial.
  • The incidence of adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

390

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

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

Subjects fulfilling all of the following criteria will be eligible for inclusion in the trial:

  • Type 2 diabetes
  • 24 ≤ BMI ≤ 35 kg/m2
  • 7 % ≤ HbA1c ≤ 8 %
  • Treated with OAD for at least 2 years
  • Treated with at least two oral antidiabetics including one sulphonylurea at the maximum tolerated dosages and metformin at the maximum tolerated dosages
  • Not treated with a glinide or thiazolidinedione.
  • Capable of performing blood glucose self-monitoring and a self-injection of insulin.
  • Funduscopy within the previous year at the time of inclusion.

Exclusion Criteria:

Patient with any of the following criteria will not be included in the trial:

  • Type 1 diabetics
  • Insulin-treated type 2 diabetics or having previously received long-term insulin, or treated with a thiazolidinedione or glinide
  • Fasting blood glucose < 1.20 g/l.
  • Pregnancy (non-menopausal women must have a pregnancy test before the inclusion visit and effective contraception).
  • Lactation.
  • History of hypersensitivity to the investigational product or to drugs with similar chemical structures.
  • Systemic treatment with corticosteroids irrespective of the dose and irrespective of the previous or anticipated duration of treatment.
  • Treatment with another product under development in the 2 months preceding the date of inclusion in the study.
  • Subject likely to receive treatments prohibited in the protocol during the trial.
  • Cardiovascular, hepatic, neurological, endocrine or any other disease making it difficult to carry out the protocol or interpret the results.
  • Proliferative or rapidly progressive or unstable retinopathy for at least 6 months after treatment by surgery or laser, or requiring surgery or laser in the 3 months following inclusion in the study.
  • Hepatic impairment:ALT and/or AST more than three times the upper limit of normal at the initial assessment.
  • Renal insufficiency:Serum creatinine >177 µmol/l (>20 mg/l) or creatinine clearance <60 ml/min.
  • Previous or current history of alcohol or drug abuse.
  • Mental state rendering the subject incapable of understanding the nature, objectives and possible consequences of the trial.
  • Inability to undertake blood glucose self-monitoring and the injection of insulin alone.
  • Subject unable to accept the restrictions of the protocol (uncooperative, unable to attend the follow-up visits and probably incapable of completing the trial).
  • Subjects deprived of freedom by an administrative or judicial decision.

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
Percentage of subjects achieving HbA1c < 7% at the end of the study.

Collaborators and Investigators

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

Sponsor

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

April 1, 2003

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOE901_4042

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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