Impact of GLP-1 RAs Compared to Basal Insulin Start in Patients Living With Type 2 Diabetes and Chronic Kidney Disease

January 24, 2024 updated by: LMC Diabetes & Endocrinology Ltd.

Impact of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Compared to Basal Insulin Start on Metabolic Targets in Patients Living With Type 2 Diabetes and Chronic Kidney Disease (Impact GLP-1 CKD)

The overall objective of this study is to compare the effectiveness of adding a glucagon-like peptide-1 receptor agonist compared with adding basal insulin for patients with type 2 diabetes and chronic kidney disease, already treated with an sodium-glucose cotransporter-2 inhibitor and not currently reaching target glycemic control. All sociodemographic information and clinical variables will be retrieved from the LMC Diabetes Registry.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a retrospective, non-inferiority cohort study using demographic and clinical data from the LMC Diabetes Registry. The study population will be adult patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) with a background antihyperglycemic treatment (AHA) of a sodium-glucose cotransporter-2 inhibitor (SGLT2i) at LMC Diabetes & Endocrinology. Two cohorts will be assessed for eligibility: patients who initiated a glucagon-like peptide-1 receptor agonist (GLP-1 RA), and patients who initiated a basal insulin, between January 2019 and December 2022. Only patients who have given consent for their medical records to be used for research purposes will be included. The date that the GLP-1 RA or the basal insulin was initiated will be considered the index date as well as the baseline date.

The LMC Diabetes Registry will be queried to retrieve information for the sociodemographic information and clinical outcomes. Baseline characteristics such as HbA1c, blood pressure, eGFR, uACR, ALT, low-density lipoprotein (LDL), high-density lipoprotein (HDL), cholesterol, triglycerides, body weight, and BMI at the time of GLP-1 RA or basal insulin initiation will be recorded. Subsequent changes in these variables, self-reported hypoglycemic events, proportion of patients with HbA1c ≤ 6.5% and ≤ 7.0%, proportion of patients who discontinued GLP-1 RA or basal insulin will be recorded at the last available follow-up visit at 26-52 weeks following the index date.

Patients initiating a GLP-1 RA will be matched 1:1 to patients initiating a basal insulin by means of propensity score matching. The propensity score (odds of participants' treatment being GLP- 1 RA) will be estimated with a logistic regression model, with GLP-1 RA use as the outcome variable and the following variables to be potentially used as covariates: age, gender, ethnicity, education, duration of T2D (years), BMI, systolic blood pressure, HbA1c at baseline, fasting plasma lipids (LDL, HDL), AHA (dual, triple, quadruple, add on to insulin), comorbidities (macrovascular complications, microvascular complications, hypertension, dyslipidemia, smoking status,), anti-hypertensive therapy, and lipid lowering therapy.

The primary objective of the study is to compare the change in HbA1c from baseline to follow-up (26-to-52 weeks) between the GLP-1 RA initiation group and the basal insulin initiation group in patients diagnosed T2D and CKD, treated with an SGLT2i. Only patients who provide a primary endpoint value at 26-52 weeks on-treatment will be included in the primary endpoint evaluation.

Study Type

Observational

Enrollment (Actual)

348

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3E8
        • LMC Diabetes & Endocrinology Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with T2D and CKD with a background antihyperglycemic treatment of an SGLT2i

Description

Inclusion Criteria:

  • 18 years or older as of the index date
  • Clinical diagnosis of T2D ≥ one year
  • Diagnosis of CKD (defined by Diabetes Canada guideline) with eGFR 15-59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 with the uACR ≥ 2mmol/L
  • Use of any SGLT2i for more than 6 months
  • Baseline HbA1c ≥7.5%

Exclusion Criteria:

  • Clinical diagnosis of type 1 diabetes (T1D)
  • Most recent eGFR ≤ 15 ml/min/1.73 m2
  • Documented history or family history of Medullary Thyroid Carcinoma or Multiple Endocrine Neoplasia type 2
  • Hypersensitivity to GLP-1 RA or any product component
  • Initiation of a second AHA therapy on the index date together with GLP-1RA
  • Previous use of any GLP-1 RA therapy
  • Previous use of basal and bolus insulin therapy
  • Participation in a research study with an Investigational Product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GLP-1 RA group
adult patients with T2D and CKD who initiated GLP-1 RA therapy
Drug: GLP-1 receptor agonist
GLP-1 RA initiated between January 2019 and December 2022
basal insulin group
adult patients with T2D and CKD who initiated basal insulin therapy
Drug: basal insulin
basal insulin initiated between January 2019 and December 2022

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in HbA1c (%)
Time Frame: baseline to 26-to-52 weeks follow-up
To compare change in HbA1c from baseline to follow-up between the GLP-1 RA initiation group and the basal insulin initiation group
baseline to 26-to-52 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LMC Diabetes & Endocrinology Ltd.

Collaborators

Novo Nordisk Canada Inc.

Investigators

  • Principal Investigator: Alexander Abitbol, MD, LMC Diabetes & Endocrinology Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Actual)

November 29, 2023

Study Completion (Actual)

November 29, 2023

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Estimated)

February 1, 2024

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Impact GLP-1 CKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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