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

September 12, 2018 updated by: Ian deBoer, University of Washington
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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Linagliptin/Glipizide
Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
Receives 4 weeks of study drug linagliptin
Receives 4 weeks of study drug glipizide
Experimental: Glipizide/Linagliptin
Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin
Receives 4 weeks of study drug linagliptin
Receives 4 weeks of study drug glipizide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Time in Range
Time Frame: last 6 days of each 28-day treatment period
Time with glucose 70-140 mg/dL
last 6 days of each 28-day treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic Variability
Time Frame: last 6 days of each 28-day treatment period
SD of glucose readings
last 6 days of each 28-day treatment period
Hypoglycemia
Time Frame: last 6 days of each 28-day treatment period
Glucose <70 mg/dL for at least 10 minutes
last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
Time Frame: last 6 days of each 28-day treatment period
Measured by plasma C-reactive protein (CRP)
last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
Time Frame: last 6 days of each 28-day treatment period
Measured by plasma interleukin-6
last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
Time Frame: last 6 days of each 28-day treatment period
Measured by plasma F2-isoprostanes
last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
Time Frame: last 6 days of each 28-day treatment period
Measured by urine F2-isoprostanes
last 6 days of each 28-day treatment period
Biomarkers of Albuminuria
Time Frame: last 6 days of each 28-day treatment period
Measured by albumin-creatinine ratio
last 6 days of each 28-day treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ian de Boer, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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