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

Type 2 Diabetes Clinical Trial

— CANDY-CANE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608177
• Other study ID #: 50084
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Drug:
• Linagliptin
Receives 4 weeks of study drug linagliptin
• Glipizide
Receives 4 weeks of study drug glipizide

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Abbott, American Diabetes Association, Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Time in Range	Time with glucose 70-140 mg/dL	last 6 days of each 28-day treatment period
Secondary	Glycemic Variability	SD of glucose readings	last 6 days of each 28-day treatment period
Secondary	Hypoglycemia	Glucose <70 mg/dL for at least 10 minutes	last 6 days of each 28-day treatment period
Secondary	Biomarkers of Systemic Inflammation	Measured by plasma C-reactive protein (CRP)	last 6 days of each 28-day treatment period
Secondary	Biomarkers of Systemic Inflammation	Measured by plasma interleukin-6	last 6 days of each 28-day treatment period
Secondary	Biomarkers of Oxidative Stress	Measured by plasma F2-isoprostanes	last 6 days of each 28-day treatment period
Secondary	Biomarkers of Oxidative Stress	Measured by urine F2-isoprostanes	last 6 days of each 28-day treatment period
Secondary	Biomarkers of Albuminuria	Measured by albumin-creatinine ratio	last 6 days of each 28-day treatment period