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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00174681
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-10
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇸🇮 Ljubljana, Slovenia