Chronic Kidney DiseasesCANDY-CANENCT02608177
Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
A study testing Linagliptin and Glipizide in people with Chronic Kidney Diseases and Type 2 Diabetes, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Type 2 Diabetes
- What is being tested?
- Linagliptin and Glipizide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- eGFR 15-59 mL/min/1.73 m2
- Hemoglobin A1c < 8%
- Age ≥ 18 years
- Current use of sulfonylurea
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Type 2 Diabetes
- Being tested
- Linagliptin, Glipizide
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
Receives 4 weeks of study drug linagliptin
GlipizideDrug
Receives 4 weeks of study drug glipizide
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin/Glipizide | Experimental | Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide Receives: Drug: Linagliptin; Drug: Glipizide |
| Glipizide/Linagliptin | Experimental | Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin Receives: Drug: Linagliptin; Drug: Glipizide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Time in Range
Time with glucose 70-140 mg/dL
Measured: last 6 days of each 28-day treatment period
Secondary outcomes (7)
Glycemic Variability
SD of glucose readings
Measured: last 6 days of each 28-day treatment period
Hypoglycemia
Glucose <70 mg/dL for at least 10 minutes
Measured: last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
Measured by plasma C-reactive protein (CRP)
Measured: last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
Measured by plasma interleukin-6
Measured: last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
Measured by plasma F2-isoprostanes
Measured: last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
Measured by urine F2-isoprostanes
Measured: last 6 days of each 28-day treatment period
Biomarkers of Albuminuria
Measured by albumin-creatinine ratio
Measured: last 6 days of each 28-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, Medtronic, Abbott
- Responsible party
- Principal investigator, Ian deBoer, University of Washington
- Investigators
- Ian de Boer, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608177
- Sponsor's protocol ID
- 50084
- Acronym
- CANDY-CANE
- Status last verified
- Aug 2018
- First submitted
- 16 Nov 2015
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
- ClinicalTrials.gov ID
- NCT02608177
- Acronym / sponsor ID
- CANDY-CANE / 50084
- Conditions
- Chronic Kidney Diseases, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- American Diabetes Association, Medtronic, Abbott
- Study start
- Nov 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linagliptin/Glipizide | Experimental | Drug: Linagliptin, Drug: GlipizideArm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide |
| Glipizide/Linagliptin | Experimental | Drug: Linagliptin, Drug: GlipizideArm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes
- eGFR 15-59 mL/min/1.73 m2
- Hemoglobin A1c < 8%
- Age ≥ 18 years
- Current use of sulfonylurea
Key exclusion criteria (6 listed)
- BMI > 40 kg/m2
- Actively using CGM for clinical care
- End stage renal disease needing dialysis
- Kidney transplant
- Pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinagliptinReceives 4 weeks of study drug linagliptin | Drug | Glipizide/Linagliptin, Linagliptin/Glipizide |
| GlipizideReceives 4 weeks of study drug glipizide | Drug | Glipizide/Linagliptin, Linagliptin/Glipizide |
Primary outcome
Glucose Time in Range
Time frame: last 6 days of each 28-day treatment period
Time with glucose 70-140 mg/dL
7 secondary outcomes
Glycemic Variability
Time frame: last 6 days of each 28-day treatment period
Hypoglycemia
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Systemic Inflammation
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Oxidative Stress
Time frame: last 6 days of each 28-day treatment period
Biomarkers of Albuminuria
Time frame: last 6 days of each 28-day treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian de Boer, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linagliptin and Glipizide in people with Chronic Kidney Diseases and Type 2 Diabetes, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Time in Range (time frame: last 6 days of each 28-day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.