The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study
NCT01966978 on ClinicalTrials.gov · last registry update 2019-10-22
An unusually large phase 4: 157 participants, more than double the 75 typical for the stage. The sponsor logged completion for December 2017. Primary outcome, as filed: Mean Change From Randomization in A1c at Week 26. liraglutide is approved in the US, but not for diabetes — a registration here is not an approval, and most drugs tested in a new condition never get one for it.
- Status
- COMPLETED
- Phase
- P4
- Drug
- liraglutideSaxenda, Victoza, Xultophy
- Sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- Other
- Enrollment
- 157
- Started
- 2014-11
- Primary completion
- 2017-12 actual
Observed history
No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.
Primary outcome
Mean Change From Randomization in A1c at Week 26
Conditions studied
Diabetes Mellitus, Type 2 · Diabetes
Every field above is taken directly from the registry record. See all detected changes across the class, or the liraglutide page for this molecule’s full trial and approval history.