Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2)

PHASE3CompletedINTERVENTIONAL
Enrollment

582

Participants

Timeline

Start Date

August 31, 2005

Study Completion Date

September 30, 2007

Conditions
Diabetes Mellitus
Interventions
DRUG

insulin glargine

Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks.

DRUG

insulin glulisine

Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks.

Trial Locations (1)

53209

Advanced Healthcare, Milwaukee

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY