28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment. (LAPTOP)

NCT00783744 Phase 3 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	375
Start date	2001-12

Conditions

• Diabetes Mellitus, Type 2

Interventions

• Insulin Glargine
• Glimepiride
• Metformin
• Insulin monotherapy with premixed insulin NPH 30/70

Primary outcomes

• Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 % — At endpoint

Countries

Austria, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom