Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: \- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives: \- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone 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 where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.
Interventions
DRUGGLIMEPIRIDE
Pharmaceutical form: oral Route of administration: oral
DRUGMETFORMIN
Pharmaceutical form: oral 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 78 Years
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes mellitus, as defined by the World Health Organization (WHO), diagnosed within one year prior to the screening visit * Signed informed consent, obtained prior to any study procedure
Exclusion criteria
* Age \< 18 and =\> 78 years old * HbA1c \< 7.6% or \> 9% * BMI \> 35 kg/m2 * Diabetes other than type 2 diabetes (e.g.: type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...) * Subjects currently receiving or who have received any hypoglycemic agent within 3 months before screening visit 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 week 24 |
| Number of patients reporting adverse events | overt the 24-weeks treatment period |
| Frequence and incidence of hypoglycemia | over the 24-weeks treatment period |
Countries
Algeria, Colombia, Egypt, Guatemala, India, Iran, Lebanon, Mexico, Russia, South Africa, Tunisia, Turkey (Türkiye), Ukraine, United Arab Emirates
Outcome results
None listed