Status: Planned First registered on: 30/04/2018
Last updated on: 05/05/2018
1. Study identification
EU PAS Register NumberEUPAS23769
Official titleStudy 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.
Study title acronymeControl Met +
Study typeObservational study
Brief description of the studyMain 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableEthical committee protocol number: P17-205 Internal code: DAP-MET-2018-01 ESR code: ESR-16-12628
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIDIAPJGol
Department/Research groupInstitut Universitari d'Investigació en Atenció Primària Jordi Gol
Organisation/affiliationIDIAPJGol
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Dr
Last name Franch-Nadal
First name Josep
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?279

IDIAPJGol
Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/05/2018
Start date of data collection01/06/2018
Start date of data analysis01/10/2018
Date of interim report, if expected03/12/2018
Date of final study report15/01/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Josep
First name Franch-Nadal
Address line 1Av. Drassanes, 17-21
Address line 2 
Address line 3 
CityBarcelona 
Postcode08001 
CountrySpain
Phone number (incl. country code)34-93-4824694 
Alternative phone number 
Fax number (incl. country code) 
Email address dap.cat.info@gmail.com
Public Enquiries
Title Mr 
Last name Vlacho 
First name Bogdan 
Address line 1Sardenya, 375 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08025 
CountrySpain 
Phone number (incl. country code)34-93-637367612 
Alternative phone number 
Fax number (incl. country code) 
Email address dap.cat.info@gmail.com 
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