Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management (CANDY-CANE)

University of Washington

Status: Completed

Conditions: Chronic Kidney Diseases; Type 2 Diabetes

Treatments: Drug: Linagliptin; Drug: Glipizide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02608177

50084

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• eGFR 15-59 mL/min/1.73 m2
• Hemoglobin A1c < 8%
• Age ≥ 18 years
• Current use of sulfonylurea

Exclusion criteria

• BMI > 40 kg/m2
• Actively using CGM for clinical care
• End stage renal disease needing dialysis
• Kidney transplant
• Pregnant or nursing
• Unable to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3 participants in 2 patient groups

Linagliptin/Glipizide

Experimental group

Description:

Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide

Treatment:

Drug: Glipizide

Drug: Linagliptin

Glipizide/Linagliptin

Experimental group

Description:

Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin

Treatment:

Drug: Glipizide

Drug: Linagliptin