Type 2 Diabetes MellitusPhase 4NCT03377335

Dapagliflozin, Cardio-Metabolic Risk Factors and Type-2 Diabetes

A Phase 4 study testing Dapagliflozin 10mg and Metformin in people with Type 2 Diabetes Mellitus, run by University of Palermo at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Dapagliflozin is a member of the sodium-glucose cotransporter-2 (SGLT2) inhibitor class antidiabetes agents which produces significant and sustained reductions in glycemic parameters in patients with type 2 diabetes (T2DM). However, its non-glycemic effects are still largely unknown. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin 10mg and Metformin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 186 participants
Where: 1 siteItaly
Study dates: 22 Dec 2017to Jan 2019
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

men and women with T2DM;
age >18;
BMI ≥20 kg/m^2;
HbA1c 7.0-9.0 %;
receiving metformin therapy at least 1500 mg/day for at least 8 weeks before screening;
plasma triglycerides <400 mg/dL, plasma LDL-cholesterol < 250 mg/dL;

Show all 9Show fewer

stabile daily dose(s) of hypolipidemic drugs (statins, ezetimibe) for at least 7 weeks prior to the day of randomization;
adequately controlled blood pressure (≤140/90 mmHg) to be maintained during the study according to Standard of Care;
able to swallow whole tablets.

Who cannot join

pregnancy or willingness to became pregnant;
severe liver dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 times upper limit of normal);
renal failure with glomerular filtration rate (eGFR) <60 ml/min/1.73m^2;
major cardiovascular event (myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack) within 12 weeks before screening;
severe infections (such as HIV and HCV);
any malignancy within 5 years before screening.

Trial locations and contacts

1 site in 1 country.

Italy1 site

University Hospital of Palermo
Palermo, 90127

Other trials in Italy

About this study

Official title: Effect of Dapagliflozin on Cardio-Metabolic Risk Factors in Patients With Type-2 Diabetes

The investigators will evaluate for the first time the effect of dapagliflozin on multiple cardio-metabolic risk markers in one study. So far, no data on the effects of dapagliflozin as well as other SGLT-2 inhibitors on subclinical atherosclerosis, endothelial function, inflammatory markers, cytokines and atherogenic lipoproteins is available.

In addition, the investigators will examine microRNAs (miRNAs) implicated in the development and progression of atherosclerotic disease. Again, no data is currently available on dapaglifozin's as well as other SGLT-2 inhibitors' effects on miRNAs.

The results of this study will show for the first time the potential multiple, non-glycemic effects of dapagliflozin, reducing multiple cardio-metabolic risk markers, which will ultimately lead to decreased CV risk.

In addition, specific mechanisms of the dapagliflozin cardiovascular action will be investigated.

Finally, the results of this study may pave the way for personalized therapy (using the results on miRNAs).

Read the detailed description

The investigators will perform an open label, two-arms, prospective intervention study using dapagliflozin+metformin vs. metformin alone for a period of 6 months in patients with T2DM.

The research hypothesis is to assess whether dapagliflozin can improve cardio-metabolic outcome, reducing subclinical atherosclerosis, endothelial dysfunction and different cardio-metabolic markers (including inflammatory markers, cytokines, oxidative stress and atherogenic lipoproteins) in patients with T2DM.

The primary objective is to assess the effects of dapagliflozin on subclinical atherosclerosis, as assessed by carotid intima-media thickness (cIMT).

Primary endpoint: Reduction in cIMT.

The secondary objective is to assess the effects of dapagliflozin on glycemic parameters (fasting plasma glucose (FPG), HbA1c), endothelial dysfunction, oxidative stress, atherogenic lipoproteins, inflammatory markers, cytokines and microRNAs (miR-130a, miR-27b, miR-29b and miR-210).

Secondary endpoint: Reduction in glycemic parameters, atherogenic lipoproteins, inflammatory markers, oxidative stress and improvements in endothelial function, cytokines and microRNAs (miR-130a, miR-27b, miR-29b and miR-210).

The full data for clinical and biochemical analyses will be collected in the same fashion at baseline and after 6 months of therapy.

Control visits by the telephone calls will be made every 2 months. However, in case of need, unplanned visits will be scheduled. Unscheduled visits will be performed in case of discontinuation, withdrawal, rescue treatment (including adverse event, episodes of hypoglycemia) or at any time during the study in case of patient's need.

Conditions: Type 2 Diabetes Mellitus
Being tested: Dapagliflozin 10mg, Metformin
Keywords: Dapagliflozin, Type 2 diabetes mellitus, Carotid intima-media thickness, Endothelial dysfunction, Atherogenic lipoproteins, Inflammatory markers, microRNAs
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 10mgDrug
Also called Forxiga®
The subjects in this arm will receive dapagliflozin (10mg daily) as add-on to metformin therapy (doses ranging from 1500 to 3000 mg daily).
Number of patients to be randomized: 93
Number of patients expected to complete the study: >87
All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment.
MetforminDrug
Also called Glucophage®
All the subjects in this arm will be on metformin therapy only (doses ranging from 1500 to 3000 mg daily).
Number of patients to be randomized: 93
Number of patients expected to complete the study: >87
All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment.

Study groups in NCT03377335
Study group	Role	What they receive
Dapagliflozin	Experimental	Dapagliflozin (10mg daily) as add-on to metformin (stable doses ranging from 1500 to 3000 mg daily). The total duration of treatment is 6 months. Receives: Drug: Dapagliflozin 10mg
Metformin alone	Placebo comparator	Metformin alone (stable doses ranging from 1500 to 3000 mg daily). The total duration of treatment is 6 months. Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Subclinical atherosclerosis
To assess the effects of dapagliflozin on subclinical atherosclerosis, as assessed by carotid intima-media thickness (cIMT).
Measured: Change from baseline to 6 months of the treatment

Secondary outcomes (5)

Endothelial dysfunction
To assess the effects of dapagliflozin on endothelial dysfunction through the evaluation of flow mediated dilation (FMD) of the brachial artery.
Measured: Change from baseline to 6 months of the treatment
Oxidative stress
To assess the effects of dapagliflozin on oxidative stress including plasma glutathione, serum lipid hydroperoxides and reactive oxygen species.
Measured: Change from baseline to 6 months of the treatment
Atherogenic lipoproteins
To assess the effects of dapagliflozin on atherogenic lipoproteins including the analysis of the full spectrum of lipoprotein subclasses by gel electrophoresis.
Measured: Change from baseline to 6 months of the treatment
Inflammatory markers
To assess the effects of dapagliflozin on inflammatory markers, including plasma cytokines (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits.
Measured: Change from baseline to 6 months of the treatment
microRNAs
To assess the effects of dapagliflozin on microRNAs. The miRNAs are endogenous 21-25 nucleotides noncoding RNA, and they are regulators of gene expression that post transcriptionally modify cellular responses and function. The miRNAs will be isolated from sera using the mirVana miRNA Isolation Kit (Ambion, Waltham, MA, USA), and then quantified by SYBR Green Real-Time (RT) polymerase chain reaction (PCR).
Measured: Change from baseline to 6 months of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 2017Jan 2019

First posted19 Dec 2017
Study start22 Dec 2017
Primary completionDec 2018 (estimated)
Study completionJan 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 186 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03377335
Sponsor's protocol ID: ESR-16-12388
Status last verified: Dec 2017
First submitted: 9 Dec 2017
Last updated: 26 Feb 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Rizzo M, Rizvi AA, Patti AM, Nikolic D, Giglio RV, Castellino G, Li Volti G, Caprio M, Montalto G, Provenzano V, Genovese S, Ceriello A. Liraglutide improves metabolic parameters and carotid intima-media thickness in diabetic patients with the metabolic syndrome: an 18-month prospective study. Cardiovasc Diabetol. 2016 Dec 3;15(1):162. doi: 10.1186/s12933-016-0480-8.
PubMed 27912784
Rizzo M, Chandalia M, Patti AM, Di Bartolo V, Rizvi AA, Montalto G, Abate N. Liraglutide decreases carotid intima-media thickness in patients with type 2 diabetes: 8-month prospective pilot study. Cardiovasc Diabetol. 2014 Feb 22;13:49. doi: 10.1186/1475-2840-13-49.
PubMed 24559258
Corrado E, Rizzo M, Coppola G, Muratori I, Carella M, Novo S. Endothelial dysfunction and carotid lesions are strong predictors of clinical events in patients with early stages of atherosclerosis: a 24-month follow-up study. Coron Artery Dis. 2008 May;19(3):139-44. doi: 10.1097/MCA.0b013e3282f3fbde.
PubMed 18418229
Salamone F, Galvano F, Marino Gammazza A, Paternostro C, Tibullo D, Bucchieri F, Mangiameli A, Parola M, Bugianesi E, Li Volti G. Silibinin improves hepatic and myocardial injury in mice with nonalcoholic steatohepatitis. Dig Liver Dis. 2012 Apr;44(4):334-42. doi: 10.1016/j.dld.2011.11.010. Epub 2011 Dec 24.
PubMed 22197629
Rizzo M, Abate N, Chandalia M, Rizvi AA, Giglio RV, Nikolic D, Marino Gammazza A, Barbagallo I, Isenovic ER, Banach M, Montalto G, Li Volti G. Liraglutide reduces oxidative stress and restores heme oxygenase-1 and ghrelin levels in patients with type 2 diabetes: a prospective pilot study. J Clin Endocrinol Metab. 2015 Feb;100(2):603-6. doi: 10.1210/jc.2014-2291. Epub 2014 Nov 13.
PubMed 25393640
Berneis K, Rizzo M, Berthold HK, Spinas GA, Krone W, Gouni-Berthold I. Ezetimibe alone or in combination with simvastatin increases small dense low-density lipoproteins in healthy men: a randomized trial. Eur Heart J. 2010 Jul;31(13):1633-9. doi: 10.1093/eurheartj/ehq181. Epub 2010 Jun 6.
PubMed 20525999
Mikhailidis DP, Elisaf M, Rizzo M, Berneis K, Griffin B, Zambon A, Athyros V, de Graaf J, Marz W, Parhofer KG, Rini GB, Spinas GA, Tomkin GH, Tselepis AD, Wierzbicki AS, Winkler K, Florentin M, Liberopoulos E. "European panel on low density lipoprotein (LDL) subclasses": a statement on the pathophysiology, atherogenicity and clinical significance of LDL subclasses. Curr Vasc Pharmacol. 2011 Sep;9(5):533-71. doi: 10.2174/157016111796642661.
PubMed 21595628
Barbagallo I, Parenti R, Zappala A, Vanella L, Tibullo D, Pepe F, Onni T, Li Volti G. Combined inhibition of Hsp90 and heme oxygenase-1 induces apoptosis and endoplasmic reticulum stress in melanoma. Acta Histochem. 2015 Oct;117(8):705-11. doi: 10.1016/j.acthis.2015.09.005. Epub 2015 Oct 19.
PubMed 26493719
Cengiz M, Yavuzer S, Kilickiran Avci B, Yuruyen M, Yavuzer H, Dikici SA, Karatas OF, Ozen M, Uzun H, Ongen Z. Circulating miR-21 and eNOS in subclinical atherosclerosis in patients with hypertension. Clin Exp Hypertens. 2015;37(8):643-9. doi: 10.3109/10641963.2015.1036064. Epub 2015 Jun 26.
PubMed 26114349
Tziomalos K, Athyros VG, Karagiannis A. Editorial: Vascular Calcification, Cardiovascular Risk and microRNAs. Curr Vasc Pharmacol. 2016;14(2):208-10. doi: 10.2174/157016111402160208150816.
PubMed 26864445
Signorelli SS, Volsi GL, Pitruzzella A, Fiore V, Mangiafico M, Vanella L, Parenti R, Rizzo M, Volti GL. Circulating miR-130a, miR-27b, and miR-210 in Patients With Peripheral Artery Disease and Their Potential Relationship With Oxidative Stress. Angiology. 2016 Nov;67(10):945-950. doi: 10.1177/0003319716638242. Epub 2016 Jul 11.
PubMed 26980776
Peng H, Zhong M, Zhao W, Wang C, Zhang J, Liu X, Li Y, Paudel SD, Wang Q, Lou T. Urinary miR-29 correlates with albuminuria and carotid intima-media thickness in type 2 diabetes patients. PLoS One. 2013 Dec 9;8(12):e82607. doi: 10.1371/journal.pone.0082607. eCollection 2013.
PubMed 24349318

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Dapagliflozin on Cardio-Metabolic Risk Factors in Patients With Type-2 Diabetes
ClinicalTrials.gov ID: NCT03377335
Acronym / sponsor ID: ESR-16-12388
Conditions: Type 2 Diabetes Mellitus
Keywords: Dapagliflozin, Type 2 diabetes mellitus, Carotid intima-media thickness, Endothelial dysfunction, Atherogenic lipoproteins, Inflammatory markers, microRNAs
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 186 participants (estimated)
Lead sponsor: University of PalermoUniversity, hospital or other
Collaborators: AstraZeneca, University of Catania
Study start: 22 Dec 2017 (actual)
Primary completion: Dec 2018 (estimated)
Study completion: Jan 2019 (estimated)
First posted: 19 Dec 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.

In addition, specific mechanisms of the dapagliflozin cardiovascular action will be investigated.

Finally, the results of this study may pave the way for personalized therapy (using the results on miRNAs).

Detailed description

The investigators will perform an open label, two-arms, prospective intervention study using dapagliflozin+metformin vs. metformin alone for a period of 6 months in patients with T2DM.

The primary objective is to assess the effects of dapagliflozin on subclinical atherosclerosis, as assessed by carotid intima-media thickness (cIMT).

Primary endpoint: Reduction in cIMT.

The full data for clinical and biochemical analyses will be collected in the same fashion at baseline and after 6 months of therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin	Experimental	Drug: Dapagliflozin 10mgDapagliflozin (10mg daily) as add-on to metformin (stable doses ranging from 1500 to 3000 mg daily). The total duration of treatment is 6 months.
Metformin alone	Placebo comparator	Drug: MetforminMetformin alone (stable doses ranging from 1500 to 3000 mg daily). The total duration of treatment is 6 months.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

men and women with T2DM;
age >18;
BMI ≥20 kg/m^2;
HbA1c 7.0-9.0 %;
receiving metformin therapy at least 1500 mg/day for at least 8 weeks before screening;

Key exclusion criteria (6 listed)

pregnancy or willingness to became pregnant;
severe liver dysfunction (alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 times upper limit of normal);
renal failure with glomerular filtration rate (eGFR) <60 ml/min/1.73m^2;
major cardiovascular event (myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack) within 12 weeks before screening;
severe infections (such as HIV and HCV);

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 10mgAlso: Forxiga®The subjects in this arm will receive dapagliflozin (10mg daily) as add-on to metformin therapy (doses ranging from 1500 to 3000 mg daily). Number of patients to be randomized: 93 Number of patients expected to complete the study: >87 All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment.	Drug	Dapagliflozin
MetforminAlso: Glucophage®All the subjects in this arm will be on metformin therapy only (doses ranging from 1500 to 3000 mg daily). Number of patients to be randomized: 93 Number of patients expected to complete the study: >87 All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment.	Drug	Metformin alone

Primary outcome

Subclinical atherosclerosis
Time frame: Change from baseline to 6 months of the treatment
To assess the effects of dapagliflozin on subclinical atherosclerosis, as assessed by carotid intima-media thickness (cIMT).

5 secondary outcomes

Endothelial dysfunction
Time frame: Change from baseline to 6 months of the treatment
Oxidative stress
Time frame: Change from baseline to 6 months of the treatment
Atherogenic lipoproteins
Time frame: Change from baseline to 6 months of the treatment
Inflammatory markers
Time frame: Change from baseline to 6 months of the treatment
microRNAs
Time frame: Change from baseline to 6 months of the treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
Background: PubMed 27912784Rizzo M, Rizvi AA, Patti AM, Nikolic D, Giglio RV, Castellino G, Li Volti G, Caprio M, Montalto G, Provenzano V, Genovese S, Ceriello A. Liraglutide improves metabolic parameters and carotid intima-media thickness in diabetic patients with the metabolic syndrome: an 18-month prospective study. Cardiovasc Diabetol. 2016 Dec 3;15(1):162. doi: 10.1186/s12933-016-0480-8.
Background: PubMed 24559258Rizzo M, Chandalia M, Patti AM, Di Bartolo V, Rizvi AA, Montalto G, Abate N. Liraglutide decreases carotid intima-media thickness in patients with type 2 diabetes: 8-month prospective pilot study. Cardiovasc Diabetol. 2014 Feb 22;13:49. doi: 10.1186/1475-2840-13-49.
Background: PubMed 18418229Corrado E, Rizzo M, Coppola G, Muratori I, Carella M, Novo S. Endothelial dysfunction and carotid lesions are strong predictors of clinical events in patients with early stages of atherosclerosis: a 24-month follow-up study. Coron Artery Dis. 2008 May;19(3):139-44. doi: 10.1097/MCA.0b013e3282f3fbde.
Background: PubMed 22197629Salamone F, Galvano F, Marino Gammazza A, Paternostro C, Tibullo D, Bucchieri F, Mangiameli A, Parola M, Bugianesi E, Li Volti G. Silibinin improves hepatic and myocardial injury in mice with nonalcoholic steatohepatitis. Dig Liver Dis. 2012 Apr;44(4):334-42. doi: 10.1016/j.dld.2011.11.010. Epub 2011 Dec 24.
Background: PubMed 25393640Rizzo M, Abate N, Chandalia M, Rizvi AA, Giglio RV, Nikolic D, Marino Gammazza A, Barbagallo I, Isenovic ER, Banach M, Montalto G, Li Volti G. Liraglutide reduces oxidative stress and restores heme oxygenase-1 and ghrelin levels in patients with type 2 diabetes: a prospective pilot study. J Clin Endocrinol Metab. 2015 Feb;100(2):603-6. doi: 10.1210/jc.2014-2291. Epub 2014 Nov 13.
Background: PubMed 20525999Berneis K, Rizzo M, Berthold HK, Spinas GA, Krone W, Gouni-Berthold I. Ezetimibe alone or in combination with simvastatin increases small dense low-density lipoproteins in healthy men: a randomized trial. Eur Heart J. 2010 Jul;31(13):1633-9. doi: 10.1093/eurheartj/ehq181. Epub 2010 Jun 6.
Background: PubMed 21595628Mikhailidis DP, Elisaf M, Rizzo M, Berneis K, Griffin B, Zambon A, Athyros V, de Graaf J, Marz W, Parhofer KG, Rini GB, Spinas GA, Tomkin GH, Tselepis AD, Wierzbicki AS, Winkler K, Florentin M, Liberopoulos E. "European panel on low density lipoprotein (LDL) subclasses": a statement on the pathophysiology, atherogenicity and clinical significance of LDL subclasses. Curr Vasc Pharmacol. 2011 Sep;9(5):533-71. doi: 10.2174/157016111796642661.
Background: PubMed 26493719Barbagallo I, Parenti R, Zappala A, Vanella L, Tibullo D, Pepe F, Onni T, Li Volti G. Combined inhibition of Hsp90 and heme oxygenase-1 induces apoptosis and endoplasmic reticulum stress in melanoma. Acta Histochem. 2015 Oct;117(8):705-11. doi: 10.1016/j.acthis.2015.09.005. Epub 2015 Oct 19.
Background: PubMed 26114349Cengiz M, Yavuzer S, Kilickiran Avci B, Yuruyen M, Yavuzer H, Dikici SA, Karatas OF, Ozen M, Uzun H, Ongen Z. Circulating miR-21 and eNOS in subclinical atherosclerosis in patients with hypertension. Clin Exp Hypertens. 2015;37(8):643-9. doi: 10.3109/10641963.2015.1036064. Epub 2015 Jun 26.
Background: PubMed 26864445Tziomalos K, Athyros VG, Karagiannis A. Editorial: Vascular Calcification, Cardiovascular Risk and microRNAs. Curr Vasc Pharmacol. 2016;14(2):208-10. doi: 10.2174/157016111402160208150816.
Background: PubMed 26980776Signorelli SS, Volsi GL, Pitruzzella A, Fiore V, Mangiafico M, Vanella L, Parenti R, Rizzo M, Volti GL. Circulating miR-130a, miR-27b, and miR-210 in Patients With Peripheral Artery Disease and Their Potential Relationship With Oxidative Stress. Angiology. 2016 Nov;67(10):945-950. doi: 10.1177/0003319716638242. Epub 2016 Jul 11.
Background: PubMed 24349318Peng H, Zhong M, Zhao W, Wang C, Zhang J, Liu X, Li Y, Paudel SD, Wang Q, Lou T. Urinary miR-29 correlates with albuminuria and carotid intima-media thickness in type 2 diabetes patients. PLoS One. 2013 Dec 9;8(12):e82607. doi: 10.1371/journal.pone.0082607. eCollection 2013.

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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 10mg and Metformin in people with Type 2 Diabetes Mellitus, run by University of Palermo at 1 site in Italy.

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 6 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: status not confirmed, as of the sponsor's last update on 26 Feb 2018. 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 Italy. 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?

Results are not available in the source record.

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?

Subclinical atherosclerosis (time frame: Change from baseline to 6 months of the treatment). 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 NCT03377335, which also lists 12 linked publications.

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 26 Feb 2018.