Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Chronic Kidney Diseases
• Interventions: Drug: Linagliptin; Drug: Glipizide

• Registration Number: NCT02608177
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-18
• Primary Completion: 2017-08
• Status Verified: 2018-08
• Study Completion: 2018-08
• Results First Submitted: 2018-08-09
• Results First Submitted QC: 2018-09-11
• Last Update Submitted: 2018-09-12
• Results First Posted: 2018-09-13
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glipizide/Linagliptin	Linagliptin	Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin
Linagliptin/Glipizide	Glipizide	Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
Linagliptin/Glipizide	Linagliptin	Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
Glipizide/Linagliptin	Glipizide	Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin

Primary Outcome Measures

Name	Time	Method
Glucose Time in Range	last 6 days of each 28-day treatment period	Time with glucose 70-140 mg/dL

Secondary Outcome Measures

Name	Time	Method
Biomarkers of Oxidative Stress	last 6 days of each 28-day treatment period	Measured by urine F2-isoprostanes
Glycemic Variability	last 6 days of each 28-day treatment period	SD of glucose readings
Biomarkers of Systemic Inflammation	last 6 days of each 28-day treatment period	Measured by plasma interleukin-6
Biomarkers of Albuminuria	last 6 days of each 28-day treatment period	Measured by albumin-creatinine ratio
Hypoglycemia	last 6 days of each 28-day treatment period	Glucose \<70 mg/dL for at least 10 minutes

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States