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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Diseases, Type 2 Diabetes

Intervention / Treatment
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* Drug: Linagliptin
* Drug: Glipizide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linagliptin/Glipizide<br>Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide | Drug: Linagliptin<br>* Receives 4 weeks of study drug linagliptin<br>Drug: Glipizide<br>* Receives 4 weeks of study drug glipizide<br>|
| Experimental: Glipizide/Linagliptin<br>Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin | Drug: Linagliptin<br>* Receives 4 weeks of study drug linagliptin<br>Drug: Glipizide<br>* Receives 4 weeks of study drug glipizide<br>|

What is the study measuring?
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Primary Outcome Measures

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