Continuous Glucose Monitoring to Assess Glycemia in Chronic Kidney Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-08-31

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.

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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.

Conditions

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Chronic Kidney Diseases Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Linagliptin/Glipizide

Arm receives 4 weeks of study drug linagliptin followed by 4 weeks of glipizide

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Receives 4 weeks of study drug linagliptin

Glipizide

Intervention Type DRUG

Receives 4 weeks of study drug glipizide

Glipizide/Linagliptin

Arm receives 4 weeks of study drug glipizide followed by 4 weeks linagliptin

Group Type EXPERIMENTAL

Linagliptin

Intervention Type DRUG

Receives 4 weeks of study drug linagliptin

Glipizide

Intervention Type DRUG

Receives 4 weeks of study drug glipizide

Interventions

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Linagliptin

Receives 4 weeks of study drug linagliptin

Intervention Type DRUG

Glipizide

Receives 4 weeks of study drug glipizide

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No