Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary objective: * To determine the optimal treatment algorithm for the clinical use of insulin glargine based on the incidence of severe hypoglycaemia. Secondary objectives: * To determine for each treatment algorithm the incidence of asymptomatic, symptomatic and nocturnal hypoglycaemia. * To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between the treatment algorithms. * To determine the difference in glycaemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment. * To obtain safety data on the use of insulin glargine in each treatment algorithm. * To measure change in subject weight and insulin dose between baseline and end of treatment. * To determine subject quality of life and treatment satisfaction (sub-study)
Interventions
DRUGInsulin glargine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with Type 2 Diabetes Mellitus, * Subjects on antidiabetic treatment (oral and/or insulin therapy) for \> 6 months, * Subjects who require a basal long-acting insulin for the control of hyperglycaemia, * HbA1c values \> 7.0% and \< 12 %, * BMI \< 40 kg/m². 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 |
|---|---|
| Incidence of severe hypoglycaemia | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of symptomatic hypoglycaemia | — |
| Incidence of nocturnal hypoglycaemia | — |
| Incidence of asymptomatic hypoglycaemia | — |
| Adjusted mean change in Hb1Ac (%) | — |
| Adjusted mean change in fasting blood glucose (FBG) (mg/dl) | — |
| Adjusted mean change in nocturnal blood glucose (NBG) (mg/dl) | — |
| Adjusted mean change in mean daily blood glucose (MBG) (mg/dl) | — |
| Incidence of any hypoglycaemia | — |
| % of subjects at v12 with Hb1Ac < or = 7.0 % | — |
| % of subjects at v12 with FBG < or = 100 mg/dl | — |
| Weight change (kg) | — |
| Change in insulin glargine dose v2 - v12 (IU) | — |
| Safety data | — |
| Quality of Life and treatment satisfaction before, during and at the end of treatment using the Diabetes Treatment Satisfaction Questionnaire | — |
| % of subjects at v12 with Hb1Ac < or = 6.5 % | — |
Outcome results
None listed