Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: * To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin. Secondary Objectives: * To evaluate the percentage of patients reaching HbA1c \< 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20. * To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20. * To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).
Detailed description
The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks.
Interventions
DRUGGlimepiride and Metformin hydrochloride combination (HOE490)
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin * Signed written informed consent
Exclusion criteria
* Type 1 diabetes mellitus * HbA1c \< 7% or \> 10% * Fasting plasma glucose \> 250 mg/dL (\> 13.9 mmol/L) * Age \<18 years or Age ≥ 80 years * Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening * Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening 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 |
|---|---|
| Absolute change in HbA1c | 20 weeks, from baseline to week 20 |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in Fasting Plasma Glucose | 20 weeks, from baseline to week 20 |
| Number of patients reporting adverse events | 20 weeks, from baseline to week 20 |
| Number of patients reporting serious adverse events | 20 weeks, from baseline to week 20 |
| Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%, respectively | 20 weeks, at week 20 |
| Vital signs | 20 weeks, from baseline to week 20 |
| Hematology, Serum chemistry and lipids | 20 weeks, from baseline to week 20 |
| Hypoglycemia | 20 weeks, from baseline to week 20 |
Countries
China
Outcome results
None listed