check_circleStudy Completed

Type 2 diabetes mellitus, Chronic kidney disease

Bayer Identifier:

21510

ClinicalTrials.gov Identifier:

NCT05004428

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to learn more about chronic kidney disease (CKD) in patients with type 2 diabetes mellitus (T2DM)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
336376
Trial Dates
August 2021 - February 2022
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Canada

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Baseline

Secondary Outcome

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

Trial design

Chronic kidney disease in type 2 diabetes mellitus
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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