drugset / Trial / NCT01966978

The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study

NCT01966978

Phase 4 Completed 157 enrolled University of Texas Southwestern Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c \> 10%).

Timeline

Start
2014-11
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Liraglutide Peptide 1.8 mg Subcutaneous
Comparator insulin aspart Protein / enzyme biologic 0.3 iu/kg Subcutaneous
Comparator Metformin Small molecule 2000 mg
Comparator insulin detemir Protein / enzyme biologic 0.3 iu/kg Subcutaneous