Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGInsulin Glargine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving HbA1c < 7% at the end of the study. | — |
Countries
Croatia, Czechia, France, Romania, Russia, Slovenia
Outcome results
None listed