tulip study: testing the usefulness of lantus when initiated prematurely in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

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.


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.