Lilly DM2 BIAM
The Impact of LY2605541 versus Insulin Glargine for Patients with Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin with Insulin Lispro: a Double-Blind, Randomized, 26-Week Study The IMAGINE 4 Study
| Protocol | |
|---|
| Identifier | I2R-MC-BIAM Site Number 162 |
|---|
| UID | 7b783767-89bb-446a-b9e9-8f5447c984f1 |
|---|
| Status | Done - Archived |
|---|
| Phase | 3 |
|---|
| Category | Diabetes Type 2 / Adult |
|---|
| Launch Year | 2012 |
|---|
| NCT Number | - |
|---|
| Created | 2011-11-07 12:50 |
|---|
| Last Updated | 2011-11-07 12:50 |
|---|
Description
Key Elements:
• Study drug LY2605541 is a new ultra-long-acting insulin. The objective of the trial is to provide efficacy data for LY2605541 compared to insulin glargine (Lantus®) as determined by change in HbA1c over 26 weeks.
• Study drug administration: OD at bedtime in a subcutaneous injection in addition to up to 3 pre-prandial (before a meal) bolus (fast-acting) injections of insulin lispro (Humalog®). Subject will be allowed to continue metformin therapy for duration of trial.
• 10 Office Visits
• $42 for each visit. Subjects will not be paid for telephone contacts or unscheduled visits.
• Body mass index of 45 kg/m2 or less at Visit 1
• HbA1c = 7.0% and < 12.0% at Screening
Comment
No comment.
