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OpenTrials
Completed

NCT Number: NCT02608177

Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease - Changing Glucose Management

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 Diabetes Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linagliptin

Drug

Receives 4 weeks of study drug linagliptin

Glipizide

Drug

Receives 4 weeks of study drug glipizide

Primary outcomes

  1. Glucose Time in Range

    Time frame: last 6 days of each 28-day treatment period

    Time with glucose 70-140 mg/dL

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Abbott
  • American Diabetes Association
  • Medtronic

Registry information

Acronym: CANDY-CANE

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 18, 2015
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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