Conditions: Diabetes Mellitus, Type 2
Keywords: Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus Insulin LISPRO Insulin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 402
Healthy volunteers: no

Brief summary:
The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.

Detailed description:

Arms:
arm 1: Twice daily (before breakfast and lunch) insulin lispro mix 50 (50% insulin lispro, 50% insulin lispro protamine suspension \[LM50\]) and once daily (before dinner) insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension \[LM25\]) arm 2: Once daily (bedtime) insulin glargine and three pre-meal insulin lispro

Interventions: intervention 1: Insulin Lispro Premix intervention 2: Insulin Glargine intervention 3: Insulin Lispro
Intervention descriptions: intervention 1: Participant dependent dose, administered subcutaneously for 24 weeks intervention 2: Participant dependent dose, administered subcutaneously for 24 weeks intervention 3: Participant dependent dose, administered subcutaneously for 24 weeks

Protocol document: