Evaluation of Fixed Dose Combination of Glimepiride and Metformin in Chinese Type 2 Diabetes Patients Inadequately Controlled With Metformin

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Glimepiride (HOE490); Drug: Glimepiride and Metformin hydrochloride combination (HOE490)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01457911

EFC11761

U1111-1121-6792 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

• To evaluate the efficacy of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone in terms of glycemic control as reflected by HbA1c during a 20-week treatment period in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin.

Secondary Objectives:

• To evaluate the percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5% of fixed dose combination of 1 mg glimepiride and 250 mg metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
• To evaluate the effect on Fasting Plasma Glucose of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg) in comparison with glimepiride (AMARYL) alone at week 20.
• To assess the safety and tolerability of fixed dose combination of glimepiride and metformin (AMARYL M 1/250mg).

Full description

The study consists of an up to 2-week screening period, a 20-week treatment period, and a 3-day safety follow-up period. Total study duration is up to 23 weeks.

Enrollment: 244 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese patients with type 2 diabetes mellitus, as defined by World Health Organization, diagnosed for at least 1 year at the time of screening visit and inadequately controlled with metformin
• Signed written informed consent

Exclusion criteria

• Type 1 diabetes mellitus
• HbA1c < 7% or > 10%
• Fasting plasma glucose > 250 mg/dL (> 13.9 mmol/L)
• Age <18 years or Age ≥ 80 years
• Patients who have not been on stable daily dose of at least 1500 mg metformin within 3 months prior to screening
• Patients currently receiving or who have received anti-diabetic drugs other than metformin within 3 months prior to screening

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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244 participants in 2 patient groups

AMARYL M (Glimepiride and Metformin hydrochloride combination)

Experimental group

Description:

AMARYL M at a dosage regimen from 1 tablet to 6 tablets, once during a meal or twice during a meal

Treatment:

Drug: Glimepiride and Metformin hydrochloride combination (HOE490)

AMARYL (Glimepiride)

Active Comparator group

Description:

AMARYL at a dosage regimen from 1 mg to 6 mg, once during a meal or twice during a meal

Treatment:

Drug: Glimepiride (HOE490)