Optimal Oral Hypoglycaemic Agents (OHA) for Combination With Insulin Glargine (Sulfonylurea vs. Metformin)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin; Drug: Insulin Glargine; Drug: Glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00708578

LANTU_L_02670

Details and patient eligibility

About

Primary objective:

To find out an optimal regimen of OHA (oral hypoglycaemic agents) in combination with insulin glargine (metformin, glimepiride or metformin+glimepiride) by measuring HbA1c level

Secondary objective:

To compare the incidence of hypoglycemia in each treatment group

Enrollment: 99 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes for at least 6 months
• Treated with maximal, tolerable dose of metformin (≥ 1000mg/day) and sulfonylurea (glimepiride≥ 4 mg/day or equivalent dose of other SU) for at least 3 months prior to the screening visit
• 7.0 < HbA1c < 11 %
• Fasting serum C-peptide > 0.33 nmol/L
• BMI < 30 kg/m²
• Patients who is willing to monitor BG using SMBG

Exclusion criteria

• Type 1 Diabetes
• Clinical evidence of active liver disease, or serum ALT 3 times the upper limit of the normal range
• Serum creatinine: ≥ 1.5 mg/dl for males, ≥ 1.4 mg/dl for females
• Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
• History of alcohol or other substance abuse
• Pregnancy or not using contraceptive in childbearing aged women
• Breast feeding women
• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
• Treatment with any medication including corticosteroid or herbal medicines that can affect blood glucose level within 3 months prior to study entry except metformin and sulfonylurea.

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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99 participants in 3 patient groups

1

Active Comparator group

Description:

Administration of 4 mg of Glimepiride with Insulin Glargine

Treatment:

Drug: Insulin Glargine

Drug: Glimepiride

2

Active Comparator group

Description:

Administration of 1500 mg of Metformin with Insulin Glargine

Treatment:

Drug: Metformin

Drug: Insulin Glargine

3

Experimental group

Description:

Administration of a combination of 4mg Glimepiride plus 1000mg Metformin with Insulin Glargine

Treatment:

Drug: Metformin

Drug: Insulin Glargine

Drug: Glimepiride