To compare efficacy, safety and durability of combination therapy with pioglitazone plus GLP-1 RA versus basal bolus insulin in poorly controlled T2DM patients on metformin plus sulfonylurea
poorly controlled (HbA1c \>7.5%) T2DM patients (18-75 years of age) on maximal/near maximal dose of sulfonylurea plus metformin who otherwise are healthy will be randomized to receive: 1. exenatide weekly injection (2 mg/week) 2. glargine insulin plus insulin aspart which will be titrated to maintain HbA1c \<7.0%
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
410
pioglitazone will be started at 30 mg/day and bydureon at 2 mg/week
the dose will be escalated to maintain HbA1c \<7.0%
Hamad General Hospital
Doha, Qatar
RECRUITINGHbA1c
difference in HbA1c between the two treatment groups will be compared at 1 and at 3 years to determine efficacy and durability of each treatment
Time frame: 3 years
percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years
Time frame: 3 years
hypoglycemia rate
will be measured as absolute event rate per patient year of follow up
Time frame: 3 years
change in the FPG
change in FPG from time zero to 1 year and from baseline to 3 years in each treatment group
Time frame: 3 years
change in body weight
change in body weight from time zero to 1 year and to 3 years in each treatment group
Time frame: 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.