Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary objective: To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients Secondary objective: To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
Interventions
DRUGInsulin glargine
Once daily in the morning
DRUGGlimepiride
Once daily in the morning
DRUGMetformin
At least 1000 mg/day
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
List of Inclusion and
Exclusion criteria
Inclusion Criteria: * Type 2 Diabetes Mellitus patients on metformin monotherapy * 7% ≤ HbA1c ≤ 12% * 20 kg/m² ≤BMI ≤ 35 kg/m² * Diabetes duration: at least 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ß-cell Function parameter | From the signature of the Informed Consent Form (ICF) up to the end of study |
| Glucose Homeostasis and glycemic control status | From the signature of the Informed Consent Form (ICF) up to the end of study |
Secondary
| Measure | Time frame |
|---|---|
| Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine | End of the study |
Countries
South Korea
Outcome results
None listed