Primary Objective: To investigate the efficacy(HbA1c) at 6 months after adding basal insulin therapy (insulin glargine) to dipeptidyl peptidase-IV (DPP-IV) and metformin plus or minus sulphonylurea Secondary Objectives: 1. To assess the efficacy by adding insulin glargine 2. To assess insulin dose 3. Safety
28 weeks (Screening: About 2 weeks/Treatment: 24 weeks (6 months)/Follow-up: 2 weeks)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
109
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Sanofi-Aventis Administrative Office
Seoul, South Korea
Response rate (percentage of patients who meet the target HbA1c ≤7%) at week 24 (6 months) after adding insulin therapy
Time frame: week 24 (6 months)
Percentage of patients with HbA1c ≤7%
Time frame: week 12 (3 months)
Change from baseline in HbA1c
Time frame: week 12 (3 months), week 24 (6 months)
Percentage of patients with HbA1c ≤6.5%
Time frame: week 12 (3 months), week 24 (6 months)
Change from baseline in Fasting Plasma glucose (FPG), 2hr-Postprandial Plasma Glucose
Time frame: week 12 (3 months), week 24 (6 months)
Total daily insulin dose
Time frame: week 24 (6 months)
Fasting blood glucose (FBG) values
Time frame: During 3 consecutive days before baseline, week 12, Week 24
7-point Self Monitoring of Blood Glucose
Time frame: During 2 days within 7 days before baseline, week 12, week 24
Weight change from baseline
Time frame: week 24 (6 months)
Number of Patients with Hypoglycemic Events
Time frame: up to 6 months
Number of Patients with Adverse Events
Time frame: up to 6 months
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Pharmaceutical form: tablet Route of administration: oral