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

NCT05004428 | Completed

• 1 other identifier: 21510
• Study Type: observational
• Target: 336,376
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease

Keywords

Cardiovascular Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus , Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Descriptive analyses of clinical characteristics of patients in database.

  Baseline

• Descriptive analyses of demographic data.

  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

Study Arms (1)

Type 2 Diabetes Mellitus patients with Chronic Kidney Disease

Canadian patients with type 2 diabetes mellitus data will be collected retrospectively.

Other: No intervention

Interventions

No intervention OTHER

Retrospective population-based study utilizing administrative data without any intervention.

Type 2 Diabetes Mellitus patients with Chronic Kidney Disease

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Canada

Location

Related 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Cardiovascular Diseases; Kidney Diseases; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; 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; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 13, 2021
• Study Start: August 14, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)