Insulin Glargine Combination Therapies in Type II Diabetics (LAPTOP)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin monotherapy with premixed insulin NPH 30/70; Drug: Glimepiride; Drug: Insulin Glargine; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783744

HOE901_4027

Details and patient eligibility

About

To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.

Enrollment: 375 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily)
• HbA1c value ≥ 7.5 % to ≤ 10.5 %
• FBG ≥ 120 mg/dl (6.6 mmol/l)
• BMI ≤ 35 kg/m²

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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375 participants in 2 patient groups

1

Experimental group

Description:

Insulin Glargine + Glimepiride + Metformin

Treatment:

Drug: Glimepiride

Drug: Insulin Glargine

Drug: Metformin

2

Active Comparator group

Description:

Insulin monotherapy with premixed insulin NPH 30/70

Treatment:

Drug: Insulin monotherapy with premixed insulin NPH 30/70