Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 426
Healthy volunteers: no

Brief summary:
The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level

Detailed description:

Arms:
arm 1: Insulin lispro low mixture (1, 2 or 3 daily injections) arm 2: Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Interventions: intervention 1: Insulin lispro low mixture intervention 2: Insulin glargine intervention 3: Insulin lispro
Intervention descriptions: intervention 1: Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required. intervention 2: Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks intervention 3: Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.

Protocol document: