Study identification

EU PAS number

EUPAS28930

Study ID

38608

Official title and acronym

An Observational/Non-interventional Evaluation of Subject Outcomes for Type 2 Diabetes Mellitus (T2DM) Subjects Prescribed Dipeptidyl Peptidase-4 Inhibitors (DPP4i), Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) or Sulphonylureas (SUs) at First Intensification

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This is an observational, non-interventional, retrospective cohort study of patients with T2DM. This study will evaluate the change in patient’s hemoglobin A1c (HbA1c) level from baseline at 6- and 12-months when a second drug is added to a patient’s treatment regimen using data from real-world clinical practice. To determine the impact of baseline HbA1c level on outcomes, data will be analysed by treatment and by strata defined by patient’s baseline HbA1c levels. Patients diagnosed with T2DM between 01 January 2002 and 31 December 2017 with a prescription for metformin followed by addition of dipeptidyl peptidase-4 inhibitors (DPP4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i) or sulphonylureas (SU) will be observed with results being reported separately for each of these three groups. Retrospective data for each patient will be extracted for a 6-month pre-index period and up to 15-years of follow-up. Index date is defined as the date of intensification of therapy. Data will be available for inclusion in the study across the period from 01 January 2001 to 31 December 2017. Data will be collected up to death, loss to follow-up or end of study period, whichever occurs first. The study will use electronic primary care medical records contained within the Clinical Practices Research Datalink (CPRD) GOLD dataset from primary care sites within the United Kingdom (UK). The overall duration of the study is approximately 6 months.

Study status

Finalised

Contact details

Marc Evans

Primary lead investigator

Study timelines

Date when funding contract was signed

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Actual:

Study start date

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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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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