Risk Factors Associated with Severe Hypoglycemia Among Patients with Type 2 Diabetes Mellitus Treated with Insulin (Risk factors for severe hypoglycemia)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39784
• EU PAS number:
  EUPAS31111
• Study ID:
  39784
• Official title and acronym:
  Risk Factors Associated with Severe Hypoglycemia Among Patients with Type 2 Diabetes Mellitus Treated with Insulin (Risk factors for severe hypoglycemia)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Diabetes mellitus is one of the most common chronic health conditions in the world. While type 2 diabetes mellitus (T2DM) can initially be managed with noninsulin therapies, insulin therapy is typically required to achieve glycemic control after disease progression. Progression of T2DM and insulin therapy can lead to a higher risk of hypoglycemia. Although hypoglycemia has been accepted by patients and providers as an inevitable consequence of preventing long-term diabetes complications, recent studies have found that hypoglycemia, including the severe form, is a potentially preventable cause of morbidity, mortality, high costs and impaired quality of life. Identification of additional risk factors will help clinicians recognize that there are factors which can lead to severe hypoglycemia and that it is essential that patients be prepared for hypoglycemia and severe hypoglycemia at all times if they are taking insulin.Primary and secondary study objectives:1. To identify risk factors for severe hypoglycemic (SH) events in insulin-treated T2DM patients. Identification of patients at different risk of SH will be based on an evaluation of risk factors of SH using a retrospective nested case-control design. 2. To describe and compare baseline demographic and clinical characteristics in the following patient subgroups:• Patients who experience at least a SH event during the index period• Patients who have not experienced a SH event3. To describe and compare healthcare resource utilization (HCRU) and cost in T2DM patients on insulin in the patient subgroups described above.Research DesignThe study is a nested case control study using incidence density sampling based on retrospective administrative claims data in U.S. The primary aim is to test potential risk factors for severe hypoglycemia in addition to well-known risk factors identified from the literature and clinical insights.
• Study status:
  Ongoing

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 30/10/2018

Study start date

Planned: 01/11/2019

Actual: 30/10/2019

Date of final study report

Planned: 30/06/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

2018-7840_T2DM SH_Non_interventional PASS Protocol_approved 30OCT2019 redacted

Updated protocol

2018-7840_V4.0_T2DMSH_2_Approved 1FEB2021_dedacted

Regulatory

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