Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary objective: To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level Secondary objective: To compare the incidence of hypoglycemia in each treatment group
Interventions
DRUGGlimepiride
Once a day before breakfast
DRUGMetformin
After breakfast and supper
DRUGInsulin Glargine
Injection in the morning
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes for at least 6 months * Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit * 7.0 \< HbA1c \< 11 % * Fasting serum C-peptide \> 0.33 nmol/L * BMI \< 30 kg/m² * Patients who is willing to monitor BG using SMBG
Exclusion criteria
* Type 1 Diabetes * Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range * Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females * Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry) * History of alcohol or other substance abuse * Pregnancy or not using contraceptive in childbearing aged women * Breast feeding women * History of hypersensitivity to the study drugs or to drugs with a similar chemical structure * Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c values | At baseline to end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycemia events | From inclusion to end of study |
| Percentage of patients with HbA1c < 7% | At the end of the study |
| Fasting Blood Glucose level | At the end of the study |
Countries
South Korea
Outcome results
None listed