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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin Glargine

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.