Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients (RECOMMEND)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: METFORMIN; Drug: GLIMEPIRIDE

Study type: Interventional

Funder types: Industry

Identifiers

NCT01459809

GLIME_R_05809

U1111-1119-9984 (Other Identifier)

Details and patient eligibility

About

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

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 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.

Enrollment: 538 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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538 participants in 3 patient groups

ARM 1: glimepiride alone

Experimental group

Description:

24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline \< 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, 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

ARM 2: metformin alone

Experimental group

Description:

24-week treatment period: After randomization, starting dose will be of 500 mg of metformin twice a day during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 2000 mg, and adjusted throughout the 24-week treatment period according to fasting 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: METFORMIN

ARM3: Glimepiride/metformin free combination

Experimental group

Description:

24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if FPG at baseline \< 180 mg/dL (10 mmol/L) taken once in the morning and 500 mg of metformin twice a day taken during or after meals. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg of glimepiride and 2000 mg of metformin, and adjusted throughout the 24-week treatment period according to fasting SMPG values in the objective to obtain values ≤.

Treatment:

Drug: METFORMIN

Drug: GLIMEPIRIDE