Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management (CANDY-CANE)
Primary Purpose
Chronic Kidney Diseases, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Linagliptin
Glipizide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
Eligibility Criteria
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
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Linagliptin/Glipizide
Glipizide/Linagliptin
Arm Description
Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin
Outcomes
Primary Outcome Measures
Glucose Time in Range
Time with glucose 70-140 mg/dL
Secondary Outcome Measures
Glycemic Variability
SD of glucose readings
Hypoglycemia
Glucose <70 mg/dL for at least 10 minutes
Biomarkers of Systemic Inflammation
Measured by plasma C-reactive protein (CRP)
Biomarkers of Systemic Inflammation
Measured by plasma interleukin-6
Biomarkers of Oxidative Stress
Measured by plasma F2-isoprostanes
Biomarkers of Oxidative Stress
Measured by urine F2-isoprostanes
Biomarkers of Albuminuria
Measured by albumin-creatinine ratio
Full Information
NCT ID
NCT02608177
First Posted
November 16, 2015
Last Updated
September 12, 2018
Sponsor
University of Washington
Collaborators
American Diabetes Association, Medtronic, Abbott
1. Study Identification
Unique Protocol Identification Number
NCT02608177
Brief Title
Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
Acronym
CANDY-CANE
Official Title
Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
American Diabetes Association, Medtronic, Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Linagliptin/Glipizide
Arm Type
Experimental
Arm Description
Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
Arm Title
Glipizide/Linagliptin
Arm Type
Experimental
Arm Description
Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Intervention Description
Receives 4 weeks of study drug linagliptin
Intervention Type
Drug
Intervention Name(s)
Glipizide
Intervention Description
Receives 4 weeks of study drug glipizide
Primary Outcome Measure Information:
Title
Glucose Time in Range
Description
Time with glucose 70-140 mg/dL
Time Frame
last 6 days of each 28-day treatment period
Secondary Outcome Measure Information:
Title
Glycemic Variability
Description
SD of glucose readings
Time Frame
last 6 days of each 28-day treatment period
Title
Hypoglycemia
Description
Glucose <70 mg/dL for at least 10 minutes
Time Frame
last 6 days of each 28-day treatment period
Title
Biomarkers of Systemic Inflammation
Description
Measured by plasma C-reactive protein (CRP)
Time Frame
last 6 days of each 28-day treatment period
Title
Biomarkers of Systemic Inflammation
Description
Measured by plasma interleukin-6
Time Frame
last 6 days of each 28-day treatment period
Title
Biomarkers of Oxidative Stress
Description
Measured by plasma F2-isoprostanes
Time Frame
last 6 days of each 28-day treatment period
Title
Biomarkers of Oxidative Stress
Description
Measured by urine F2-isoprostanes
Time Frame
last 6 days of each 28-day treatment period
Title
Biomarkers of Albuminuria
Description
Measured by albumin-creatinine ratio
Time Frame
last 6 days of each 28-day treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian de Boer, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
We'll reach out to this number within 24 hrs