Study about the results of the addition of a sulfonylurea, DPP4 inhibitors or SGLT2 inhibitors as a second antidiabetic drug in patients with diabetes mellitus type 2 in treatment with metformin and insufficient glycemic control. (eControl Met +)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23770
• EU PAS number:
  EUPAS23769
• Study ID:
  23770
• Official title and acronym:
  Study about the results of the addition of a sulfonylurea, DPP4 inhibitors or SGLT2 inhibitors as a second antidiabetic drug in patients with diabetes mellitus type 2 in treatment with metformin and insufficient glycemic control. (eControl Met +)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Main objective:To compare the proportion of patients that achieve the reduction of HbA1c of at least 0.5%, and weight reduction of at least 3%, after the addition of a sulfonylurea, an DPP-4i or an SGLT-2i to the treatment with metformin in patients with T2DM and insufficient glycemic control up to a maximum of 24-month follow-up period.Methodology:Retrospective longitudinal cohort study with a maximum of 24-month follow-up period. Data will be collected from SIDIAP databases, which obtains data from electronic health care records of 75% of the Catalonia population attended in Primary Care facilities. We define as study population, patients diagnosed with type 2 diabetes mellitus on treatment with metformin and insufficient glycemic control that initiate treatment with a sulphonylurea, a DPP-4i or a SGLT-2i as a second antidiabetic drug during 2010-2015. The 3 cohorts will be formed and matched by propensity score technique according to age, sex, HbA1c and weight at the time of inclusion. Main determinations: Weight and Hb1Ac during 6, 12 and 24 months of follow-up and baseline characteristics for demographic variables and comorbidities related to their addition to the prescribed treatment. Statistical analysis: For the main analysis it will be used, the regression model of the mixed effects line and the COX models for the estimation of incidence and risk rates. Each dependent variable will be adjusted for baseline demographic factors and for predictive factors.Expected results:The data obtained from this study will improve the knowledge about the effects of the addition of a second oral antidiabetic.Relevance: There is a need for a large-scale observational study to know the effects of the three most common strategies for the second therapeutic choice for T2DM in real practice conditions.Keywords: Complications, glycemic control, type 2 diabetes mellitus, treatment.
• Study status:
  Planned

Research institutions and networks

Institutions

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Study timelines

Date when funding contract was signed

Planned: 15/05/2018

Study start date

Planned: 01/06/2018

Data analysis start date

Planned: 01/10/2018

Date of interim report, if expected

Planned: 03/12/2018

Date of final study report

Planned: 15/01/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

eControl Met+_definitivo_sin control de cambios_03.04.2018

Regulatory

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

Other study registration identification numbers and links

Ethical committee protocol number:P17-205Internal code:DAP-MET-2018-01ESR code:ESR-16-12628