Treatment Patterns, and Treatment Outcomes Before and After Humulin R U-500 Initiation and Device Switch Among Type 2 Diabetes Patients in the United States Treated with a Total Daily Dose of ≤ 200 Units of Insulins per Day (U-500R Lower Dose Cohort)

Study identification

• EU PAS number:
  EUPAS32169
• Study ID:
  39152
• Official title and acronym:
  Treatment Patterns, and Treatment Outcomes Before and After Humulin R U-500 Initiation and Device Switch Among Type 2 Diabetes Patients in the United States Treated with a Total Daily Dose of ≤ 200 Units of Insulins per Day (U-500R Lower Dose Cohort)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study is a retrospective real-world study using Veteran Health Administration database to evaluate treatment patterns and treatment outcomes before and after U-500R exposure among T2DM patients who utilized less ≤200 units/day of insulins either before or after U-500R exposure
• Study status:
  Finalised

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 09/09/2019

Actual: 09/09/2019

Study start date

Planned: 11/11/2019

Actual: 15/11/2019

Data analysis start date

Planned: 29/11/2019

Date of final study report

Planned: 31/12/2019

Actual: 05/01/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

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