Type 2 Diabetes MellitusPhase 4NCT03919656
SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease
A Phase 4 study testing Dapagliflozin 10 mg in people with Type 2 Diabetes Mellitus, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Dapagliflozin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 12 May 2019to 23 May 2024
- Phase
- Phase 4
- 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
Who may be able to join
- Age 18-75.
- BMI 27-39.9 kg/m2.
- T2DM on treatment with metformin and inadequate metabolic control (defined as HbA1c≥6.5 -7%).
Who cannot join
- Pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test)
- Breastfeeding
- Intolerance/allergy to dapagliflozin.
- Treatment with antidiabetic drug other than metformin.
- Impaired kidney function: Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 (calculated using the CKD-EPI formula).
- Patients with established cardiovascular disease.
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- Previous or current history of cancer of any kind.
- Uncontrolled hypertension (systolic blood pressure≥160 mmHg or diastolic blood pressure≥110 mmHg, despite adequate antihypertensive treatment).
- History of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels> 2.0 mg / dl or GOT/GPT levels three times higher than normal upper limit.
- Known HIV infection or active HBV or HCV infection.
- Other serious underlying diseases, which could affect the patient's ability to participate in the study.
- Reduced life expectancy (<12 months) due to advanced or terminal concomitant diseases.
- In addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Virgen de la Victoria University Hospital. Endocrinology Department
Málaga, Spain, 29010
About this study
Official title: SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardio- and Nephroprotection
This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.
Read the detailed description
In this study, we hypothesize that metabolomics changes that occur in patients with T2DM after initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors) treatment may be responsible for the beneficial cardiovascular and kidney effects observed in clinical trials with SGLT2i. Also, we propose that the study of the specific metabolome associated with the treatment with SGLT2i could help identify the possible metabolites and molecules that reduce CVD (cardiovascular disease) and renal disease in patients with T2DM.
The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily of for 12 weeks. Besides, all participants will be advised to engage in 150 min or more of moderate-to vigorous intensity physical activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity and to engage in 2-3 sessions/week of resistance exercise on nonconsecutive days. Moreover, these patients will be advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the individual's baseline body weight.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Dapagliflozin 10 mg, Placebo Oral Tablet
- Keywords
- Metabolomics, Dapagliflozin
- 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.
Dapagliflozin 10 mgDrug
Also called Farxiga 10 mg
Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)
Placebo Oral TabletDrug
Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10 mg daily (orally) Receives: Drug: Dapagliflozin 10 mg |
| Placebo | Placebo comparator | Matching placebo for dapagliflozin daily (orally). Does not contain active ingredient Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics changes in blood
Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines
Measured: From baseline to week 12
Metabolomics changes in urine
Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines
Measured: From baseline to week 12
Secondary outcomes (5)
BMI (body mass index) changes
Measured by body composition analysis
Measured: From baseline to to week 12
Changes in insulin resistance
Measured as HOMA-IR (homeostatic model assessment of insulin resistance)
Measured: From baseline to to week 12
Changes in metabolic control
Measured as HbA1c (glycated hemoglobin)
Measured: From baseline to to week 12
Changes in Quality of Life: 36-Item Short Form Health Survey (SF-36) questionnaire
The SF-36 has eight scaled scores: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The scores are weighted sums of the questions in each section. Scores range from 0 - 100, lower scores indicate more disability, and higher scores indicate less disability
Measured: From baseline to to week 12
Changes in albuminuria
Modifications in albuminuria, measured as albumin excretion rate (AER)
Measured: From baseline to to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start12 May 2019
- Primary completion12 Jan 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Carlos Fernandez-Garcia, MD, PhD, Principal investigator, Virgen de la Victoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919656
- Sponsor's protocol ID
- FIM-DAPA-2018-01
- Status last verified
- Jun 2025
- First submitted
- 11 Apr 2019
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardio- and Nephroprotection
- ClinicalTrials.gov ID
- NCT03919656
- Acronym / sponsor ID
- FIM-DAPA-2018-01
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Metabolomics, Dapagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 12 May 2019 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 18 Apr 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.
This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.
Detailed description
In this study, we hypothesize that metabolomics changes that occur in patients with T2DM after initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors) treatment may be responsible for the beneficial cardiovascular and kidney effects observed in clinical trials with SGLT2i. Also, we propose that the study of the specific metabolome associated with the treatment with SGLT2i could help identify the possible metabolites and molecules that reduce CVD (cardiovascular disease) and renal disease in patients with T2DM.
The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily of for 12 weeks. Besides, all participants will be advised to engage in 150 min or more of moderate-to vigorous intensity physical activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity and to engage in 2-3 sessions/week of resistance exercise on nonconsecutive days. Moreover, these patients will be advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the individual's baseline body weight.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10 mgDapagliflozin 10 mg daily (orally) |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletMatching placebo for dapagliflozin daily (orally). Does not contain active ingredient |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75.
- BMI 27-39.9 kg/m2.
- T2DM on treatment with metformin and inadequate metabolic control (defined as HbA1c≥6.5 -7%).
Key exclusion criteria (13 listed)
- Pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test)
- Breastfeeding
- Intolerance/allergy to dapagliflozin.
- Treatment with antidiabetic drug other than metformin.
- Impaired kidney function: Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2 (calculated using the CKD-EPI formula).
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 |
|---|---|---|
| Dapagliflozin 10 mgAlso: Farxiga 10 mgDapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally) | Drug | Dapagliflozin |
| Placebo Oral TabletGreen, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient | Drug | Placebo |
Primary outcome
Metabolomics changes in blood
Time frame: From baseline to week 12
Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines
Metabolomics changes in urine
Time frame: From baseline to week 12
Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines
5 secondary outcomes
BMI (body mass index) changes
Time frame: From baseline to to week 12
Changes in insulin resistance
Time frame: From baseline to to week 12
Changes in metabolic control
Time frame: From baseline to to week 12
Changes in Quality of Life: 36-Item Short Form Health Survey (SF-36) questionnaire
Time frame: From baseline to to week 12
Changes in albuminuria
Time frame: From baseline to to week 12
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 15 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Jose Carlos Fernandez-Garcia, MD, PhD principal investigator
Virgen de la Victoria Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10 mg in people with Type 2 Diabetes Mellitus, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 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 3 inclusion and 13 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 15 Jun 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Metabolomics changes in blood (time frame: From baseline to week 12). The study lists 2 primary outcomes in all. 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 15 Jun 2025.