Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26317
• EU PAS number:
  EUPAS13060
• Study ID:
  26317
• Official title and acronym:
  Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes in the United States
• DARWIN EU® study:
  No
• Study countries:
  Sweden

  United States
• Study description:
  This study will estimate the incidence of diabetic ketoacidosis among patients diagnosed with T2DM initiating prescribed diabetes medication overall and by diabetes medication class and combinations of classes. This will be retrospective cohort analysis conducted in United States-based administrative claims data.
• Study status:
  Finalised

Research institutions and networks

Institutions

Truven Health Analytics

AstraZeneca, Sweden

Study timelines

Date when funding contract was signed

Planned: 15/10/2015

Actual: 15/10/2015

Study start date

Planned: 01/01/2012

Actual: 01/01/2012

Data analysis start date

Planned: 01/08/2016

Date of final study report

Planned: 09/12/2016

Actual: 04/08/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)