Monitoring for proteinuria in patients with type 2 diabetes mellitus (Proteinuria monitoring in type 2 diabetes)

Study identification

• EU PAS number:
  EUPAS9159
• Study ID:
  14906
• Official title and acronym:
  Monitoring for proteinuria in patients with type 2 diabetes mellitus (Proteinuria monitoring in type 2 diabetes)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  Patients with Type 2 diabetes mellitus (T2DM) are at risk of developing diabetic renal complications. National Institute for Health and Care Excellence (NICE) guidelines recommend at least annual monitoring of diabetic patients for proteinuria. It is unknown if frequency of proteinuria testing varies by age, gender, renal complications, or antidiabetic drug therapy. This study aims to describe frequency of proteinuria monitoring, and whether the frequency of proteinuria testing varies by demographics (age, sex), smoking status, calendar year, renal complication or antidiabetic treatment. The proportion of proteinuria in patients with T2DM will also be obtained. This retrospective cohort study will identify T2DM patients who started treatment with an antidiabetic medication during 2007-2013 in Clinical Practice Research Datalink (CPRD). For simplicity, analyses focused on time to first proteinuria test. Monitoring rate was calculated as the number of patients with at least one proteinuria test during follow-up, divided by the sum of time to the first proteinuria test during follow-up, and during substratum of the follow-up period. Among patients with at least one test undertaken, the proportion of patients with the first test result status will be calculated. The findings from this study will be used for hypothesis generating for a future study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Multiple centres: 2 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 04/03/2013

Actual: 04/03/2013

Study start date

Planned: 04/03/2013

Actual: 04/03/2013

Data analysis start date

Planned: 01/06/2013

Actual: 01/06/2013

Date of final study report

Planned: 31/12/2014

Actual: 20/11/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable