Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: -To demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of HbA1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus. Secondary Objective: To assess the effects of the fixed combination of glimepiride and metformin at week 24 on: * Percentage of patients reaching HbA1c \<7% * Percentage of patients reaching HbA1c \<6.5%. * Fasting Plasma Glucose (FPG) * Safety and tolerability
Detailed description
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.
Interventions
DRUGGlimepiride+metformin (Amaryl M®) - HOE4900
Pharmaceutical form:tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (SU) alone or metformin alone or a free combination of SU and metformin prior to the study entry. * Signed informed consent, obtained prior any study procedure
Exclusion criteria
* Age \< legal age of adulthood * HbA1c \< 7% or ≥ 11% * BMI \> 35 kg/m2 * Treatment with a stable dose of maximally tolerated SU alone or metformin alone or the free combination of SU and metformin for less than 12 weeks prior to the screening visit. * Patients who received any anti-diabetic drug other than SU or metformin within 12 weeks prior to the screening visit. * Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake…) 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 |
|---|---|
| Change in HbA1c | from baseline to week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with HbA1c < 7% | at week 24 |
| Percentage of patients with HbA1c < 6.5% | at week 24 |
| Change in Fasting Plasma Glucose (FPG) | from baseline to week 24 |
| Number of patients with adverse events | over the 24-week treatment period |
| Hypoglycemia | over the 24-week treatment period |
Countries
Lebanon, Russia, Ukraine
Outcome results
None listed