Diabetes Mellitus, Type 2NCT04149067
Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain
An observational study of Diabetes Mellitus, Type 2, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The aim of this study is to develop a retrospective, multicenter and observational study in Spain in real clinical practice to assess the employment of dapagliflozin and to compare its effectiveness and safety with the data of sitagliptin, a DPP4 inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin and Sitagliptin
- How many people
- 1,080 participants
- Where
- 1 siteSpain
- Study dates
- 5 Jun 2017to 15 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old with stable DM2 with antihyperglycaemic therapy, being included in their treatment dapagliflozin or sitagliptin medication.
Who may be able to join
- Patients diagnosed with T2DM.
- Age: 18-75 years.
- Treatment with dapagliflozin or sitagliptin that started at least 6 months before the recruitment date.
- The patient must have at least two follow-up visits. The basal initial visit, where all the relevant information is collected and a second follow-up visit.
- The next information of the subjects should be available at the recruitment of the basal visit: Sex, age (years), date of diagnosis of T2DM, weight, height, systolic and diastolic blood pressure, body mass index (BMI: kg / m2), concomitant medication (antiHTA, statins, aspirin, etc.), glucose basal fasting (mg / dL), HbA1c (%) and estimated GFR by CKD-EPI (mL / min / 1.73m2).
- 5. The patient must sign the informed consent to participate in the study.
Who cannot join
- Impediment of the patient to give him informed consent.
- Patients diagnosed with Type 1 Diabetes.
- Women with gestational diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective and Multicenter Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain
The aim of this study is to develop a retrospective, multicenter and observational study in Spain in real clinical practice to assess the employment of dapagliflozin and to compare its effectiveness and safety with the data of sitagliptin, a DPP4 inhibitor. This is a widely used molecule in Spain with a large safety profile. It was chosen as a comparator because of the number of patients treated and because it is a real alternative at the time of making a decision about the treatment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin, Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called iSGLT2
Evaluation of the effectiveness and safety of the Dapagliflozin treatment.
SitagliptinDrug
Also called iDPP4
Evaluation of the effectiveness and safety of the Sitagliptin treatment.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin cohort | Patients diagnosed with type 2 diabetes that started dapagliflozin treatment at least 6 months before the beginning of the study. Receives: Drug: Dapagliflozin | |
| Sitagliptin cohort | Patients diagnosed with type 2 diabetes that started sitagliptin treatment at least 6 months before the beginning of the study. Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months +/- 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months +/- 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start5 Jun 2017
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Cristobal Morales Portillo, Study director, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149067
- Sponsor's protocol ID
- FIS-DAP-2016-01
- Status last verified
- May 2019
- First submitted
- 17 Sep 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Multicenter Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain
- ClinicalTrials.gov ID
- NCT04149067
- Acronym / sponsor ID
- FIS-DAP-2016-01
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to develop a retrospective, multicenter and observational study in Spain in real clinical practice to assess the employment of dapagliflozin and to compare its effectiveness and safety with the data of sitagliptin, a DPP4 inhibitor. This is a widely used molecule in Spain with a large safety profile. It was chosen as a comparator because of the number of patients treated and because it is a real alternative at the time of making a decision about the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin cohort | – | Drug: DapagliflozinPatients diagnosed with type 2 diabetes that started dapagliflozin treatment at least 6 months before the beginning of the study. |
| Sitagliptin cohort | – | Drug: SitagliptinPatients diagnosed with type 2 diabetes that started sitagliptin treatment at least 6 months before the beginning of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old with stable DM2 with antihyperglycaemic therapy, being included in their treatment dapagliflozin or sitagliptin medication.
Key inclusion criteria (6 listed)
- Patients diagnosed with T2DM.
- Age: 18-75 years.
- Treatment with dapagliflozin or sitagliptin that started at least 6 months before the recruitment date.
- The patient must have at least two follow-up visits. The basal initial visit, where all the relevant information is collected and a second follow-up visit.
- The next information of the subjects should be available at the recruitment of the basal visit: Sex, age (years), date of diagnosis of T2DM, weight, height, systolic and diastolic blood pressure, body mass index (BMI: kg / m2), concomitant medication (antiHTA, statins, aspirin, etc.), glucose basal fasting (mg / dL), HbA1c (%) and estimated GFR by CKD-EPI (mL / min / 1.73m2).
Key exclusion criteria (3 listed)
- Impediment of the patient to give him informed consent.
- Patients diagnosed with Type 1 Diabetes.
- Women with gestational diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinAlso: iSGLT2Evaluation of the effectiveness and safety of the Dapagliflozin treatment. | Drug | Dapagliflozin cohort |
| SitagliptinAlso: iDPP4Evaluation of the effectiveness and safety of the Sitagliptin treatment. | Drug | Sitagliptin cohort |
Primary outcome
0.5% in Hb1Ac and 1.5 kg in body weight
Time frame: 6 months +/- 3 months
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.
2 secondary outcomes
Evaluate the results due to the use of SGLT2i/DPP4i
Time frame: 6 months +/- 3 months
Evaluate the security of the treatment
Time frame: 6 months +/- 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristobal Morales Portillo study director
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
0.5% in Hb1Ac and 1.5 kg in body weight (time frame: 6 months +/- 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.