Observational, Cross-sectional Multicenter Study to Characterize and to Determine the Proportion of Ambulatory Type 2 Diabetes Mellitus Patients with Mild to Moderate Hypoglycemia Episodes according to their background therapy in Portugal; HypoglycemIa in POrtugal Study – PHARMAcy (HIPOS-PHARMA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/13487
• EU PAS number:
  EUPAS12848
• Study ID:
  13487
• Official title and acronym:
  Observational, Cross-sectional Multicenter Study to Characterize and to Determine the Proportion of Ambulatory Type 2 Diabetes Mellitus Patients with Mild to Moderate Hypoglycemia Episodes according to their background therapy in Portugal; HypoglycemIa in POrtugal Study – PHARMAcy (HIPOS-PHARMA)
• DARWIN EU® study:
  No
• Study countries:
  Portugal
• Study description:
  Diabetes Mellitus (DM) is a chronic illness with both incidence and prevalence increasing worldwide. Although life style modifications play an important role in type 2 DM treatment, due to the progressive natural course of the disease, most of the patients also require pharmacotherapy targeted to glycemic control. One of the major challenges in the treatment of DM is to achieve glycemic control while avoiding episodes of hypoglycemia. In Portugal, hypoglycemia severity and frequency remain poorly documented. In light with this, the aim of this study is to characterize and to determine the proportion of ambulatory type 2 DM patients with mild to moderate hypoglycemia episodes in Portugal treated with antihyperglycemic agent (AHA).This is an observational, cross-sectional multicenter study of treated type 2 DM, recruited through community pharmacies, which will collect information through a structured questionnaire delivered upon the presentation of a prescription to purchase an AHA. Study population comprised type 2 diabetics aged over 40, which agree to participate and sign an informed consent. Patients are required to be at least for 3 months in the current AHA and will be assigned into one of the four different therapeutic groups (Group 1: Insulin based therapy, Group 2: Secretagogue based therapy, Group 3: Other AHA excluding Secretagogue and insulin, and Group 4: Combination of Insulin and Secretagogue). This study was approved by the Bioethics Institute of the Catholic University of Portugal.
• Study status:
  Ongoing

Research institutions and networks

Institutions

National Association of Pharmacies Portugal (ANF)

Portugal

Study timelines

Date when funding contract was signed

Planned: 04/01/2016

Actual: 04/01/2016

Study start date

Planned: 04/04/2016

Actual: 04/04/2016

Data analysis start date

Planned: 31/05/2016

Date of final study report

Planned: 31/08/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme (MSD), Medinfar Group and Tecnifar

Regulatory

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