Newer glucose-lowering agents versus thiazolidinediones on risk of incident cirrhosis and clinical decompensation events in patients with diabetes (Second-line GLDs and liver complications)

Study identification

• EU PAS number:
  EUPAS31539
• Study ID:
  37964
• Official title and acronym:
  Newer glucose-lowering agents versus thiazolidinediones on risk of incident cirrhosis and clinical decompensation events in patients with diabetes (Second-line GLDs and liver complications)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Aim 1) To estimate the effects of newer glucose-lowering agents versus TZD on risk of incident cirrhosis in patients with diabetes. Newer glucose-lowering agents to be examined are SGLT2 inhibitors and the incretin therapies, dipeptyl peptidase-4 (DPP4) inhibitors and GLP-1 receptor agonists. Aim 2) To estimate the effect of newer glucose-lowering agents (described above) versus TZD on risk of clinical decompensation events in patients with cirrhosis and diabetes.
• Study status:
  Finalised

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Study timelines

Date when funding contract was signed

Planned: 25/09/2019

Actual: 25/09/2019

Study start date

Planned: 25/09/2019

Actual: 25/09/2019

Data analysis start date

Planned: 25/09/2019

Actual: 25/09/2019

Date of final study report

Planned: 25/08/2020

Actual: 06/11/2020

Sources of funding

Other

More details on funding

NIH T32 DK007634, Royster Society of Fellows

Regulatory

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