Comparative effectiveness of insulin vs analogues to prevent complications of diabetes (CER insulin vs analogues)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6780
• EU PAS number:
  EUPAS6779
• Study ID:
  6780
• Official title and acronym:
  Comparative effectiveness of insulin vs analogues to prevent complications of diabetes (CER insulin vs analogues)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  The major challenge concerning the treatment of diabetes is representended by the prevention of vascular and metabolic diabetic complications and the related consequences for the health status of patients.Human insulin and/or its analogues are used to treat both type 1 diabetes mellitus, from its first onset, and type 2 diabetes, in its advanced phase. For both types of insulin, different formulations with different time to onset and duration of action, are currently available in order to provide patients with the most appropriate therapeutic option to mantain blood glucose concenration within the phisiological range throughout the day. In fact, different long-term follow-up studies of randomized clinical trials have found an association between inadequate plasma glucose control and the occurrence of diabetes complications. Insulin analogues possess benefit relative to human insulins in terms of glycemic control however, little is known about the long-term comparative effectiveness of insulin analogue with respect to human insulins in reducing the risk of cardiovascular and metabolic complications of diabetes. The main objective of this study was to assess the risk of diabetes complications in patients treated with insulin analogues against those using human insulin in a clinical pratice setting (i.e. Tuscany region). The secondary scope of this study was to evaluate healthcare costs respectively associated with the use of human insulins and insulin analogues (e.g. pharmacological treatment related to diabetes, hospitalizations, diagnostic procedures).
• Study status:
  Finalised

Research institutions and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

Study timelines

Date when funding contract was signed

Planned: 09/09/2013

Actual: 09/09/2013

Study start date

Planned: 30/09/2013

Actual: 18/11/2013

Date of final study report

Planned: 02/04/2014

Actual: 09/06/2014

Sources of funding

Pharmaceutical company and other private sector 

Other

More details on funding

Eli Lilly Italia, ARS

Study protocol

Initial protocol

Protocollo_Lilly

Regulatory

• Was the study required by a regulatory body?:
  No