- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02608177
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
Conditions
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Linagliptin
- Glipizide
Other Study ID Numbers
- 50084
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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