Study Primary Objectives: To compare glycemic control, as measured by hemoglobin A1c (A1C), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin. Study Secondary Objectives : To compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro: * Incidence of hypoglycemia * Change in weight * Change in serum lipid profile * Percentage of subjects achieving A1C levels ≤7%
The planned duration of enrollment is 6 months. The study consists of 2 weeks screening phase and a study period that was planned to be 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
212
solution for subcutaneous injection
suspension for subcutaneous injection
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Change from baseline in hemoglobin A1c (HbA1c) levels at week 24
Time frame: 24 weeks
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 7.0% at Week 24
Time frame: 24 weeks
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) values ≤ 8.0% at Week 24
Time frame: 24 weeks
Change from baseline in fasting plasma glucose (FBG) values at week 24
Time frame: 24 weeks
Change from baseline in serum lipid values at week 24
Time frame: 24 weeks
Number and severity of hypoglycemic events and time of occurrence of hypoglycemic events
Time frame: 24 weeks
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