A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)

Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study

In people with type 2 diabetes (T2D), the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.

People with T2D are at a higher risk of having a condition called chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People with CKD can have trouble breathing and often have swelling in their arms and legs, and high blood pressure.

People who have CKD and T2D are more likely to have other medical problems, such as heart disease.

There are many treatments available to patients who have CKD and T2D. But, researchers need more information about how doctors in Canada are deciding which treatment to give these patients.

In this study, the researchers will review health information from men and women with T2D who visited a doctor in 2019 and had check-ups for at least 6 months. The health information will be taken from a Canadian registry (or database) owned by LMC Diabetes & Endocrinology. The registry contains information from people that went to an LMC clinic. In this study, the researchers will learn how many of these people had T2D and CKD. They will learn the treatments these people received, and if they had other related medical problems. The researchers will also use surveys to ask the doctors about why they chose certain treatments.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease in Type 2 Diabetes
• Intervention / Treatment: Drug: The physician's prescription in routine clinical practice

• Study Type: Observational
• Enrollment (Actual): 14873

Contacts and Locations

Study Locations

• Canada
  • A Database, Canada
    • A Database

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include active LMC patients with T2D. This population will be used to determine the prevalence of CKD in patients with T2D. Patients identified with T2D and CKD will form the cohort for all subsequent analysis.

Description

Inclusion Criteria:

• Clinical diagnosis of T2D as captured in the LMC EMR system
• Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
• Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort
• Informed consent to use patient medical record data for research purposes was provided

Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be used to identify the cohort of patients with T2D and CKD

Exclusion Criteria:

- Any patients with documented non-diabetic etiology for renal disease will be excluded from the numerator (number of patients with CKD and T2D) when determining the primary endpoint

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with T2D; Active patients (defined as patients seen by an LMC endocrinologist between January 1, 2019 and December 31, 2019) with T2D (Type 2 Diabetes). Among the patients with T2D, those identified with CKD will be included in the renal registry.	Drug: The physician's prescription in routine clinical practice; This is an Observational study that will not involve prescription of the drugs.
Healthcare providers; Healthcare providers caring for patients with CKD and T2D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with CKD in a large T2D population	The data will be retrieved from the LMC Diabetes Registry, a Pan-Canadian registry of diabetes community-based specialist practices and used to develop a renal registry to investigate the primary objectives of the study	Retrospectively analysis between January 1, 2019 and December 31, 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients using the different therapies	The therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2i	Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with stage 1 CKD with moderate or greater albuminuria, stage 2 CKD with moderate or greater albuminuria, stage 3a CKD, stage 3b CKD, stage 4 CKD and stage 5 CKD in accordance with Canadian clinical practice guidelines	Stage 1 CKD: eGFR (estimated glomerular filtration rate) ≥ 90 ml/min/1.73 m^2 Stage 2 CKD: eGFR between 60-89 ml/min/1.73 m^2 Stage 3a CKD: eGFR between 45-59 ml/min/1.73 m^2 Stage 3b CKD: eGFR between 30-44 ml/min/1.73 m^2 Stage 4 CKD: eGFR between 15-29 ml/min/1.73 m^2 Stage 5 CKD: eGFR <15 ml/min/1.73 m^2	Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines	Microalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR > 20 mg/mmol	Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines	KDIGO = Kidney Disease: Improving Global Outcomes	Retrospectively analysis between January 1, 2019 and December 31, 2019
Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months	Laboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACR	Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with different comorbidities	Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease	Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition	RAS: renin angiotensin system ACEi: angiotensin converting enzyme inhibitors ARB: angiotensin receptor blocker Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D	On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition	GLP-1 RA: glucagon-like peptide-1 receptor agonist Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D	On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition	MRAs: mineralocorticoid receptor antagonists Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D	On the day of healthcare provider completes a questionnaire
Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition	SGLT2i: sodium-glucose co-transporter-2 inhibitors Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D	On the day of healthcare provider completes a questionnaire

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• Chu L, Fuller M, Jervis K, Ciaccia A, Abitbol A. Prevalence of Chronic Kidney Disease in Type 2 Diabetes: The Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study. Clin Ther. 2021 Sep;43(9):1558-1573. doi: 10.1016/j.clinthera.2021.07.015. Epub 2021 Aug 21.

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): November 23, 2020
• Study Completion (Actual): November 23, 2020

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 21190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No