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

NCT06236672 | Completed

• 1 other identifier: Impact GLP-1 CKD
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Chronic Kidney Diseases

Keywords

type 2 diabetes; chronic kidney disease; GLP-1 RA; basal insulin; antihyperglycemic medication

Outcome Measures

Primary Outcomes (1)

• change in HbA1c (%)

  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

Study Arms (2)

GLP-1 RA group

adult patients with T2D and CKD who initiated GLP-1 RA therapy

Drug: GLP-1 receptor agonist

basal insulin group

adult patients with T2D and CKD who initiated basal insulin therapy

Drug: basal insulin

Interventions

GLP-1 receptor agonist DRUG

GLP-1 RA initiated between January 2019 and December 2022

GLP-1 RA group

basal insulin DRUG

basal insulin initiated between January 2019 and December 2022

basal insulin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• Novo Nordisk Canada Inc.: collaborator

Study Sites (1)

LMC Diabetes & Endocrinology Ltd.

Toronto, Ontario, M4G 3E8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexander Abitbol, MD

  LMC Diabetes & Endocrinology Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: February 15, 2023
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)