A Study to Learn More About Chronic Kidney Disease (CKD) in Patients With Type 2 Diabetes Mellitus (T2DM) (CKD-T2DM)

Chronic Kidney Disease in Type 2 Diabetes Mellitus

In this observational study, data from the recent past of patients with type 2 diabetes mellitus and chronic kidney disease will be studied.

Type 2 diabetes mellitus (T2DM) is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. About half of people with T2DM also have a condition called chronic kidney disease (CKD). In people with CKD, the kidneys' ability to work as how it should decreases over time.

In this study, researchers want to learn more about the CKD in T2DM patients in Alberta, Canada. This will help them to know the chances to improve the care of these patients.

The researchers will look at the health information from adult men and women in Alberta who were diagnosed with T2DM before 2018 and visited a doctor to have check-ups in 2018. They will find out about how many of these people had CKD and how severe their CKD was. The researchers will collect data about the age and gender of these patients, how long they had T2DM and if they had other related medical problems. The researchers will also learn how these patients were treated based on their kidney condition and how much money was spent on these treatments.

This study will collect information from the health records of about 270,000 patients with T2DM who were living in Alberta, Canada. This information will come from the Alberta Kidney Disease Network (AKDN) database. Besides this data collection, no further tests or examinations are planned in this study.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 336376

Contacts and Locations

Study Locations

• Canada
  • Multiple Locations, Canada
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients medical history data from Alberta Kidney Disease Network (AKDN) with Type 2 diabetes by chronic kidney disease (CKD) stage and by rate of CKD progression will be collected retrospectively.

Description

Inclusion Criteria:

• A cohort of adults (18 years and older) with Type 2 Diabetes Mellitus (T2DM) who resided in Alberta on the index date (December 31, 2018) and were registered with Alberta Health will be included. All Alberta residents are eligible for Alberta Health Insurance Plan coverage and over 99% participate.

Exclusion Criteria:

• Patients with type 1 DM (T1DM) (International Classification of Diseases, Ninth Revision [ICD-9] code: 250.x1 and 250.x3) in any of their previous records.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Type 2 Diabetes Mellitus patients with Chronic Kidney Disease; Canadian patients with type 2 diabetes mellitus data will be collected retrospectively.	Other: No intervention; Retrospective population-based study utilizing administrative data without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Type 2 Diabetes Mellitus (T2DM) patients with Chronic Kidney Disease (CKD) in database.	Percentage of T2DM patients with CKD as per hemoglobin A1C, and stage of CKD as defined by a) baseline Kidney Disease: Improving Global Outcomes (KDIGO) guidelines CKD category, and b) eGFR ≥25 to <75 mL/min/1.73 m2 and ACR ≥30 to ≤5,000 mg/g.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive analyses of clinical characteristics of patients in database.	Duration of diabetes, comorbities and slope of eGFR	Baseline
Descriptive analyses of demographic data.	Age, sex, urban or rural residence.	Baseline
Rate of decline in estimated glomerular filtration rate (eGFR)		Retrospectively 3 years
Number of patients with CKD dispensed the medication or therapeutic class over a 1-year time period		from January 1, 2018 to December 31, 2018
The proportion of patients with CKD that experience a health outcome of interest over a 1-year time period		from January 1, 2018 to December 31, 2018
Health care resource utilization among patients		from January 1, 2018 to December 31, 2018
Annual average costs among patients		from January 1, 2018 to December 31, 2018

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2021
• Primary Completion (ACTUAL): February 11, 2022
• Study Completion (ACTUAL): February 11, 2022

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (ACTUAL): August 13, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Kidney Diseases; Diabetes Mellitus , Type 1
• 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: 21510

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