Summary:
Overview
RESEARCH STUDY SUMMARY
EFC12626 Get Goal Duo-2
PURPOSE
A randomized, open-label 26-week study to compare the efficacy and safety of lixisenatide to Apidra once daily and Apidra 3 times daily in people with Type 2 Diabetes who are not well-controlled on insulin glargine with or without metformin. Medication is experimental for this study.
Eligibility
Inclusion:
- Adults with Type 2 diabetes mellitus diagnosed at least 1 year ago
- Treatment with basal insulin for at least 6 months, with a stable dose greater than or equal to 20 U/day for at least 2 months
- Must be on a stable dose of basal insulin and on stable dose of Metformin, SU, glinides or DPP-4 inhibitor.
Exclusion:
- Type 1 diabetes
- Body Mass Index less than 20 or greater 40
- Previous treatment with a short or rapid acting insulin
- History of hypersensitivity to basal insulin