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

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ClinicalTrials.gov Identifier: NCT02608177
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : September 13, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
American Diabetes Association
Medtronic
Abbott
Information provided by (Responsible Party):
Ian deBoer, University of Washington

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Type 2 Diabetes Drug: Linagliptin Drug: Glipizide Not Applicable

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  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management
Study Start Date : November 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Linagliptin/Glipizide
Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide
Drug: Linagliptin
Receives 4 weeks of study drug linagliptin

Drug: Glipizide
Receives 4 weeks of study drug glipizide

Experimental: Glipizide/Linagliptin
Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin
Drug: Linagliptin
Receives 4 weeks of study drug linagliptin

Drug: Glipizide
Receives 4 weeks of study drug glipizide




Primary Outcome Measures :
  1. Glucose Time in Range [ Time Frame: last 6 days of each 28-day treatment period ]
    Time with glucose 70-140 mg/dL


Secondary Outcome Measures :
  1. Glycemic Variability [ Time Frame: last 6 days of each 28-day treatment period ]
    SD of glucose readings

  2. Hypoglycemia [ Time Frame: last 6 days of each 28-day treatment period ]
    Glucose <70 mg/dL for at least 10 minutes

  3. Biomarkers of Systemic Inflammation [ Time Frame: last 6 days of each 28-day treatment period ]
    Measured by plasma C-reactive protein (CRP)

  4. Biomarkers of Systemic Inflammation [ Time Frame: last 6 days of each 28-day treatment period ]
    Measured by plasma interleukin-6

  5. Biomarkers of Oxidative Stress [ Time Frame: last 6 days of each 28-day treatment period ]
    Measured by plasma F2-isoprostanes

  6. Biomarkers of Oxidative Stress [ Time Frame: last 6 days of each 28-day treatment period ]
    Measured by urine F2-isoprostanes

  7. Biomarkers of Albuminuria [ Time Frame: last 6 days of each 28-day treatment period ]
    Measured by albumin-creatinine ratio



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608177


Locations
United States, Washington
University of Washington
Seattle, Washington, United States
Sponsors and Collaborators
University of Washington
American Diabetes Association
Medtronic
Abbott
Investigators
Principal Investigator: Ian de Boer, MD University of Washington
  Study Documents (Full-Text)

Documents provided by Ian deBoer, University of Washington:

Responsible Party: Ian deBoer, Associate Professor, Medicine/Nephrology, University of Washington
ClinicalTrials.gov Identifier: NCT02608177     History of Changes
Other Study ID Numbers: 50084
First Posted: November 18, 2015    Key Record Dates
Results First Posted: September 13, 2018
Last Update Posted: October 12, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Linagliptin
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action