The goal of this study is to test whether a dipeptidyl peptidase-4 inhibitor, compared with a sulfonylurea, improves time in normal blood glucose range and reduces blood glucose variability. Blood glucose is measured using a continuous glucose monitoring device.
This is a proof-of-concept clinical trial testing the effects of linagliptin versus glipizide on glucose variability among people with type 2 diabetes and stage 3-4 CKD. In a cross-over design, each enrolled participant will receive 28 days of each study medication. Study medications will be provided in a randomly assigned order without blinding. The primary study outcome is glucose time in range, measured by blinded continuous glucose monitoring for the last 6 days of each 28-day treatment period. Secondary outcomes include indices of glycemic variability, hypoglycemia, and biomarkers of systemic inflammation, oxidative stress, and albuminuria. The overall goal of this research is to identify safe and effective treatments to control glycemia among patients with diabetes and CKD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3
Receives 4 weeks of study drug linagliptin
Receives 4 weeks of study drug glipizide
University of Washington
Seattle, Washington, United States
Glucose Time in Range
Time with glucose 70-140 mg/dL
Time frame: last 6 days of each 28-day treatment period
Glycemic Variability
SD of glucose readings
Time frame: last 6 days of each 28-day treatment period
Hypoglycemia
Glucose \<70 mg/dL for at least 10 minutes
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
Measured by plasma C-reactive protein (CRP)
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
Measured by plasma interleukin-6
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
Measured by plasma F2-isoprostanes
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
Measured by urine F2-isoprostanes
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Albuminuria
Measured by albumin-creatinine ratio
Time frame: last 6 days of each 28-day treatment period
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