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

Type 2 Diabetes Mellitus Clinical Trial

— CKD-T2DM  

Official title:

Chronic Kidney Disease in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05004428
• Other study ID #: 21510
• Status: Completed
• Start date: August 14, 2021
• Est. completion date: February 11, 2022

Study information

• Verified date: February 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336376
• Est. completion date: February 11, 2022
• Est. primary completion date: February 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Other:
• No intervention
Retrospective population-based study utilizing administrative data without any intervention.

Locations

Country	Name	City	State
Canada	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Descriptive analyses of clinical characteristics of patients in database.	Duration of diabetes, comorbities and slope of eGFR	Baseline
Secondary	Descriptive analyses of demographic data.	Age, sex, urban or rural residence.	Baseline
Secondary	Rate of decline in estimated glomerular filtration rate (eGFR)		Retrospectively 3 years
Secondary	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
Secondary	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
Secondary	Health care resource utilization among patients		from January 1, 2018 to December 31, 2018
Secondary	Annual average costs among patients		from January 1, 2018 to December 31, 2018

External Links

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