The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
426
Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily
Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily)
Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily
Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
A1C represents percentage of glycosylated hemoglobin.
Time frame: Baseline to Week 54
Percentage of Participants With Hypoglycemic Events
Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy.
Time frame: Baseline up to 28 days following the last dose of study therapy
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
Time frame: Baseline to Week 54
Change From Baseline in Body Weight at Week 54
Time frame: Baseline to Week 54
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily