Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
CANDY-CANE
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
September 13, 2018
CompletedOctober 12, 2018
August 1, 2018
1.8 years
November 16, 2015
August 9, 2018
September 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Glucose Time in Range
Time with glucose 70-140 mg/dL
last 6 days of each 28-day treatment period
Secondary Outcomes (7)
Glycemic Variability
last 6 days of each 28-day treatment period
Hypoglycemia
last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
last 6 days of each 28-day treatment period
- +2 more secondary outcomes
Study Arms (2)
Linagliptin/Glipizide
EXPERIMENTALArm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
Glipizide/Linagliptin
EXPERIMENTALArm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- eGFR 15-59 mL/min/1.73 m2
- Hemoglobin A1c \< 8%
- Age ≥ 18 years
- Current use of sulfonylurea
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- American Diabetes Associationcollaborator
- Medtroniccollaborator
- Abbottcollaborator
Study Sites (1)
University of Washington
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ian de Boer, Associate Director
- Organization
- Kidney Research Institute, University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Ian de Boer, MD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Medicine/Nephrology
Study Record Dates
First Submitted
November 16, 2015
First Posted
November 18, 2015
Study Start
November 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2018
Last Updated
October 12, 2018
Results First Posted
September 13, 2018
Record last verified: 2018-08