Efficacy and Safety of the Fixed Dose Combination of Glimepiride+Metformin in Type 2 Diabetic Patients Inadequately Controlled (LEGEND)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Glimepiride+metformin (Amaryl M®) - HOE4900

Study type: Interventional

Funder types: Industry

Identifiers

NCT01699932

U1111-1120-0058 (Other Identifier)

GLMET_R_05823

Details and patient eligibility

About

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

Full 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.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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167 participants in 1 patient group

Arm 1

Experimental group

Description:

24-week treatment period: starting dose will be of 2/1000 mg or 4/2000 mg of glimepiride/metformin fixed combination (Amaryl M® ) depending on the previous treatment and dose. The Interventional medicinal product's dose will be increased every 2 weeks up to the maximum tolerated dose of 8/2000 mg of Amaryl M® , and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and \> 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.

Treatment:

Drug: Glimepiride+metformin (Amaryl M®) - HOE4900