| Trial ID: | L3571 |
| Source ID: | NCT04149067
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| Associated Drug: |
Dapagliflozin
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| Title: |
Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Dapagliflozin|DRUG: Sitagliptin
|
| Outcome Measures: |
Primary: 0.5% in Hb1Ac and 1.5 kg in body weight, The aim of the study is to assess the effectiveness of the SGLT2i (dapagliflozin) and DPP4i (Sitagliptin) over the composite endpoint of Hb1Ac and weight at six month of treatment. The main variable is composite, including Hb1Ac and body weight. It will be evaluated the proportion of patient to achieve a change of 0.5% in Hb1Ac and 1.5 kg in body weight. It was chosen sitagliptin because the researchers involved in this study have much experience with this molecule with a large number of patients already treated., 6 months +/- 3 months | Secondary: Evaluate the results due to the use of SGLT2i/DPP4i, Assessment of the SGLT2i/DPP4i use in single, double or triple therapy and analysis of the baseline features of the patients at the beginning and at the end of the treatment, including the concomitant medication., 6 months +/- 3 months|Evaluate the security of the treatment, Study of the incidence of the urinary and genital infections as well as the hypoglycemia incidence and its severity., 6 months +/- 3 months
|
| Sponsor/Collaborators: |
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | Collaborators: AstraZeneca
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
|
| Enrollment: |
1080
|
| Study Type: |
OBSERVATIONAL
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| Study Designs: |
Observational Model: |Time Perspective: p
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| Start Date: |
2017-06-05
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| Completion Date: |
2019-03-15
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| Results First Posted: |
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| Last Update Posted: |
2019-11-04
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| Locations: |
Cristóbal Morales Portillo, Sevilla, Andalucía, 41009, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT04149067
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