Treatment Patterns, Treatment Outcomes, and Out-of-Pocket Pharmacy Costs Before and After Humulin R U-500 Initiation Among Type 2 Diabetes Patients in the United States Utilizing a Total Daily Dose of >180 units per Day (High Dose U500)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39162
• EU PAS number:
  EUPAS39161
• Study ID:
  39162
• Official title and acronym:
  Treatment Patterns, Treatment Outcomes, and Out-of-Pocket Pharmacy Costs Before and After Humulin R U-500 Initiation Among Type 2 Diabetes Patients in the United States Utilizing a Total Daily Dose of >180 units per Day (High Dose U500)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Evaluate HbA1c, Hypoglycemia, adherence, and out-of-pocket costs before and after U-500R initiation in real-world setting among the patients who used U-500R in the way that was consistent with label
• Study status:
  Finalised

Research institution and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 01/09/2018

Actual: 05/05/2019

Study start date

Planned: 01/10/2018

Actual: 05/06/2019

Date of final study report

Planned: 31/12/2020

Actual: 05/01/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

SIMR_Eli Lilly_Protocol_VHA Truven_U-500R High-Dose Cohort_Final_to_LEO

Regulatory

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