Type-2 DiabetesPhase 4Cinétique DAPANCT03269058
Evaluate the Effects of Dapagliflozin in Patients With Type 2 Diabetes
A Phase 4 study testing Dapagliflozin in people with Type-2 Diabetes and Oral Antidiabetics, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type-2 Diabetes, Oral Antidiabetics
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2017to 6 May 2021
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons who have provided written consent
- type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
- Stable treatment for 3 months
- HbA1c between 7.5% and 10%
- Age between 30 and 65 years
- BMI between 25 and 35 kg/m²
Show all 9Show fewer
- Triglycerides < 300 mg/dl
- Half of the patients being treated with statins
- eGFR > 75 ml/min/1.73 m² at inclusion
Who cannot join
- persons without national health insurance cover
- patients treated with Insulin or a GLP-1 agonist
- Patients under guardianship
- patients treated with lipid-lowering drugs (except statins for 50% of patients)
- kidney failure
- liver failure or abnormal liver function ASAT or ALAT >3 x upper limit of normal
Show all 13Show fewer
- total bilirubin >2mg/dl
- intestinal disease
- serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies)
- Pregnancy, breastfeeding
- hypersensitivity to the active substance or to excipients
- patients with volume depletion, for example due to an acute disease (gastro-intestinal disease)
- patients treated with loop diuretics or thiazides
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes
This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.
The information will:
Read more
- reveal what is not working properly
- make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning
This biomedical research will take place at the University Hospitals of DIJON and NANTES.
- 28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
- The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
- Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
- Participation in the study will last 6 months and include 4 protocol visits.
- Conditions
- Type-2 Diabetes, Oral Antidiabetics
- Being tested
- Dapagliflozin, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin 10 mg daily per os
PlacebosDrug
Placebo of Dapagliflozin per day per os
| Study group | Role | What they receive |
|---|---|---|
| Patients not treated with statins | Experimental | Not described Receives: Drug: Dapagliflozin; Drug: Placebos |
| Patients treated with statins | Experimental | Not described Receives: Drug: Dapagliflozin; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline the rate of production of VLDL Apo B
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of IDL Apo B
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of LDL Apo B
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of HDL Apo A1
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of IDL Apo B
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of LDL Apo B
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1
Measured: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start20 Dec 2017
- Primary completion6 May 2021
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type-2 DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269058
- Sponsor's protocol ID
- VERGES AZ 2015
- Acronym
- Cinétique DAPA
- Status last verified
- Mar 2026
- First submitted
- 25 Aug 2017
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verges B, Rouland A, Bouillet B, Pais de Barros JP, Fourmont C, Buffier P, Jourdan T, Vergas V, Duvillard L. Dapagliflozin does not impair LDL catabolism and induces a shift towards a closer to normal VLDL1/VLDL2 catabolism in individuals with type 2 diabetes: a randomised in vivo kinetic study. Diabetologia. 2026 Jul 17. doi: 10.1007/s00125-026-06810-6. Online ahead of print.
PubMed 42467086
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03269058
- Acronym / sponsor ID
- Cinétique DAPA / VERGES AZ 2015
- Conditions
- Type-2 Diabetes, Oral Antidiabetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 31 Aug 2017 (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 will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.
The information will:
- reveal what is not working properly
- make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning
This biomedical research will take place at the University Hospitals of DIJON and NANTES.
- 28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
- The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
- Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
- Participation in the study will last 6 months and include 4 protocol visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients not treated with statins | Experimental | Drug: Dapagliflozin, Drug: Placebos |
| Patients treated with statins | Experimental | Drug: Dapagliflozin, Drug: Placebos |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- persons who have provided written consent
- type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors)
- Stable treatment for 3 months
- HbA1c between 7.5% and 10%
- Age between 30 and 65 years
Key exclusion criteria (13 listed)
- persons without national health insurance cover
- patients treated with Insulin or a GLP-1 agonist
- Patients under guardianship
- patients treated with lipid-lowering drugs (except statins for 50% of patients)
- kidney failure
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 |
|---|---|---|
| DapagliflozinDapagliflozin 10 mg daily per os | Drug | Patients not treated with statins, Patients treated with statins |
| PlacebosPlacebo of Dapagliflozin per day per os | Drug | Patients not treated with statins, Patients treated with statins |
Primary outcome
Change from baseline the rate of production of VLDL Apo B
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of IDL Apo B
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of LDL Apo B
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the rate of production of HDL Apo A1
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL1 Apo B
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of VLDL2 Apo B
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of IDL Apo B
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of LDL Apo B
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
Change from baseline the Fractional Catabolic Rate of HDL 'Apo A1
Time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180
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 5 Mar 2026.
- Derived from this study: PubMed 42467086Verges B, Rouland A, Bouillet B, Pais de Barros JP, Fourmont C, Buffier P, Jourdan T, Vergas V, Duvillard L. Dapagliflozin does not impair LDL catabolism and induces a shift towards a closer to normal VLDL1/VLDL2 catabolism in individuals with type 2 diabetes: a randomised in vivo kinetic study. Diabetologia. 2026 Jul 17. doi: 10.1007/s00125-026-06810-6. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Type-2 Diabetes and Oral Antidiabetics, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 9 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 5 Mar 2026. 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 France. 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.
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?
Change from baseline the rate of production of VLDL Apo B (time frame: 15 days before treatment initiation, Day 0, Day 90 and Day 180). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269058, which also lists 1 linked publication.
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 5 Mar 2026.