Initiation and Titration of Amaryl (AMIT KZ)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: GLIMEPIRIDE + METFORMIN

Study type: Interventional

Funder types: Industry

Identifiers

NCT01144728

U1111-1116-9956 (Other Identifier)

GLMET_L_04718

Details and patient eligibility

About

Primary Objective:

• To describe the conditions of initiation and titration of Amaryl M, according to previous treatment:
• initial dose
• titration scheme
• efficacy after 4 months assessed by HbA1C
• tolerability (number and severity of hypoglycaemia)

Secondary Objective:

• Fasting Plasma Glucose
• Weight evolution

Enrollment: 172 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Type 2 diabetes who have been treated with a stable dose (any dose) of :
• sulfonylurea monotherapy or
• metformin monotherapy or
• free combination of glimepiride and metformin with a stable dose (any dose)
• Body Mass Index (BMI) between 20 and 40 kg/m2
• HbA1c superior or egal to 7.5%
• FPG superior or egal 7 mmol/l

Exclusion criteria

• Secondary or insulin-dependant diabetes
• Any severe chronic disease (hepatic, renal impairments)
• History of major cardiovascular event in the last 6 months
• Acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, IV administration of iodinated contrast agents
• Allergy to sulfonylurea, metformin
• Drug or alcohol abuse
• Pregnancy, lactation

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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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172 participants in 1 patient group

Single arm Glimepiride+metformin

Experimental group

Description:

Start and titration based on FBG and tolerance. Titration should be achieved within maximum 4 weeks.

Treatment:

Drug: GLIMEPIRIDE + METFORMIN