Opposing Step-by-step Insulin Reinforcement to Intensified Strategy
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00174642
- Lead Sponsor
- Sanofi
- Brief Summary
Primary objectives :
* To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
* To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
Secondary objectives :
* To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c \<= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 811
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 insulin secretagogue Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue 1 Insulin Glargine Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin 1 Insulin Glulisine Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin 1 Metformin Insulin Glargine + 3 bolus of Insulin Glulisine + Metformin 2 Insulin Glargine Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin 2 Insulin Glulisine Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin 2 Metformin Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin 3 Insulin Glargine Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue 3 Insulin Glulisine Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue 3 Metformin Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue
- Primary Outcome Measures
Name Time Method HbA1c From the beginning to the end of the study 24-hour blood glucose levels From the beginning to the end of the study symptomatic hypoglycemia (diurnal and nocturnal) From the beginning to the end of the study Severe hypoglycemia (diurnal and nocturnal), From the beginning to the end of the study Insulin doses From the beginning to the end of the study
- Secondary Outcome Measures
Name Time Method Vital signs From the beginning to the end of the study Adverse events From the beginning to the end of the study
Trial Locations
- Locations (1)
Sanofi-Aventis
🇬🇧Guildford, United Kingdom