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

NCT ID: NCT00174681

Last Updated: 2011-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Insulin Glargine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Valérie Pilorget, MD

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Zagreb, , Croatia

Sanofi-Aventis

Prague, , Czechia

Sanofi-Aventis

Paris, , France

Sanofi-Aventis

Bucharest, , Romania

Sanofi-Aventis

Moscow, , Russia

Sanofi-Aventis

Ljubljana, , Slovenia

Countries

Croatia; Czechia; France; Romania; Russia; Slovenia

Other Identifiers

HOE901_4042

Identifier Type: -

Identifier Source: org_study_id