Glimepiride+metformin (Amaryl M®) - HOE4900
DrugPharmaceutical form:tablet
Route of administration: oral
NCT Number: NCT01699932
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 3
Investigational Site Number 422-002, Beirut, Lebanon
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pharmaceutical form:tablet
Route of administration: oral
Time frame: from baseline to week 24
Time frame: at week 24
Time frame: at week 24
Time frame: from baseline to week 24
Time frame: over the 24-week treatment period
Time frame: over the 24-week treatment period
Sanofi
Industry
A Multinational, Open Label, Non Comparative, 24-week Study to Evaluate the Blood Glucose Lowering Efficacy and Safety of a Fixed Dose Combination of Glimepiride and Metformin in Patients With Inadequately Controlled Type 2 Diabetes
Acronym: LEGEND
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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