Primary Objective: To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL). Secondary Objective: A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of: * Glycaemic parameters: 7 blood glucose profiles * Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia * Change in lipid status
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
345
Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day. The dose adjustments will be based on the results of self-monitoring.
Sanofi-Aventis Administrative Office
Berlin, Germany
Health Assessment, Patient treatment satisfaction and Quality-of-Life
Time frame: At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint)
Glycaemic parameters assessment
Time frame: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Anteropometric data (Weight, waist circumference) assessment
Time frame: At baseline (visit 2: randomization), 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Lipid assessment
Time frame: At 24 weeks after the randomization (visit 7) and 48 weeks after the randomization (visit 12: endpoint)
Hypoglycemia assessment
Time frame: Throughout the study from starting until the week 48
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