Diabetes MellitusPhase 4NCT02887677
Effects of Dapagliflozin on Central Hemodynamics and Urine Albumin Excretion in Patients With Type 2 Diabetes.
A Phase 4 study testing Dapagliflozin in people with Diabetes Mellitus, run by Hellenic Society for Medical Education at 3 sites in Greece.
Trial summary
This study is designed to test the hypothesis that the treatment-induced reductions in the ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the group of placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 3 sitesGreece
- Study dates
- Oct 2016to Oct 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and ≤75 years old
- Type 2 diabetes mellitus
- Glycated hemoglobin ≥7% and ≤ 9%
- Patients on monotherapy or combination of two of the following type of antidiabetic agents :metformin, sulphonylurea,DPP-4 inhibitor,or insulin for the past 3 months.
- Patient to provide informed consent
Who cannot join
- Hypovolemic patients.
- Patients on loop diuretics.
- Patients with low BP (office SBP <110 mmHg) or orthostatic hypotension (BP drop >20 mmHg and SBP <110 mmHg in standing position at 1 min).
- Patients on GLP-1 receptor agonist or pioglitazone.
- Secondary hypertension.
- Stage 2 hypertension or higher (office SBP ≥160 mmHg or DBP ≥100 mmHg).
Show all 15Show fewer
- Chronic kidney disease stage 3 or higher (GFR<60 mL/min/1.73 m2).
- Myocardial infarction or unstable angina episode within the past 3 months, or congestive heart failure class III-IV according to New York Heart Association criteria.
- Pregnancy or childbearing potential [defined as women which have entered menses and are not post-menopausal (menopause is defined as the absence of menses for at least 12 months without any other medical cause in women of typical age) or women that have been subjected to permanent sterilization (ie. tubal ligation, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)].
- History of liver disease or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN or total bilirubin >2.0 mg/dL.
- History of malignancy of any organ system (resected basal cell carcinoma considered cured is exempted) within the past 5 years prior to Visit 1 (V1).
- History of drug or alcohol abuse within the last one year.
- Any contraindication or history of hypersensitivity to the study drug or to drugs with similar chemical structures.
- Any other surgical or medical condition that, in the opinion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
- Intake of an investigational drug in another trial within 30 days prior to Visit 1 (V1).
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Ahepa Hospital
Thessaloniki, 54621
Hippokrateio Hospital
Thessaloniki, 54642
Papageorgiou Hospital
Thessaloniki, 56429
About this study
Official title: A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes
This study is designed to test the hypothesis that the treatment-induced reductions in the ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the group of placebo.
It is a 12 week, double-blind, randomized, placebo-controlled clinical trial of dapagliflozin versus placebo in 160 adult patients with type 2 diabetes mellitus (DM). It will be conducted in three centers.
Read more
Potentially eligible patients will be asked to provide written informed consent (Screening Visit). Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit the sites one week (Visit 1 - V1) after the screening visit. On Visit 2 (V2) all eligible patients will be randomized to one of the two treatment arms and will continue with the next visits as appropriate (Visit 3, Telephone Visit 1, Visit 4-end of study).
Aortic blood pressure (BP) and arterial stiffness parameters will be measured as indicated by the protocol in V1 and V3 with the Mobil-O-Graph monitor.
Blood samples will be collected as indicated by the protocol in Screening Visit for the measurement of glycated hemoglobin (HbA1c), creatinine and liver function parameters. In addition, blood samples will be collected in V1 and V3 for routine hematological and biochemical tests including creatinine, fasting glucose, HbA1c, lipid profile and liver function parameters.
Urine samples will be collected as indicated by the protocol in V1 and V3 for the measurement of albumin to creatinine ratio.
Read the detailed description
Study design
Screening visit: Potentially eligible patients will be asked to provide written informed consent. The investigators will record full medical history, clinical examination, demographic characteristics, electrocardiogram (ECG), body weight, height, body mass index (BMI) and waist perimeter. Office blood pressure (BP) will be measured by the physicians three times using a mercury sphygmomanometer [cuffs will be placed at the level of brachial artery and a three minute interval will intercept each measurement, following 10 minutes of rest in the seated position (the cuff will cover at least 80% of the brachial circumference and 2/3 of the brachial length.)]. The investigators will also collect blood samples to determine glycated hemoglobin (HbA1C), creatinine, glomerular filtration rate (GFR) and liver function.
Visit 1 (V1): Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit the sites 1 week after the screening visit (+/-2 days), following a 12-hour fast. Three measurements of office BP at the level of brachial artery, with a three minutes interval between each measurement, will be performed with the use of a mercury sphygmomanometer, after 10 minutes-rest in the sitting posture (cuff with bladder size encircling at least 80% of arm circumference and covering two thirds of arm length). After that, venous blood specimens and a spot urine specimen will be collected for relevant blood tests and albumin/creatinine ratio (ACR) respectively. Subsequently, the Mobil-O-Graph monitor with a cuff of appropriate size will be fitted and the BP recording will be initiated for 24 hours. The device will be programmed to collect data every 20 minutes, except for 23:00 to 07:00 (data collection every 30 minutes).
Visit 2 (V2): An appointment will be scheduled the following day for the patient to drop-off the Mobil-O-Graph device. Patients will be randomized in a 1:1 ratio to the dapagliflozin or placebo group and will start receiving the drug regimen the same day. Moreover, all patients will receive dietary and lifestyle advice commencing from this visit.
Telephone Visit 1 (ΤV1): A telephone visit (TV1) will be scheduled 6 weeks after V2 (+/-2 days). Patient history will be obtained, emphasizing on possible adverse events during the previous 6 weeks. Home blood glucose levels, if available, would be also discussed.
Visit 3 (V3): Visit 3 will be scheduled 6 weeks after telephone visit 1 (TV1) (+/-2 days). The following parameters will be determined: medical history of the last weeks, clinical examination (including three brachial BP measurements with a mercury sphygmomanometer as mentioned before), venous blood specimen collection (under 12-hour fast) and the initiation of 24-hour ambulatory blood pressure monitoring (ABPM) (Mobil-O-Graph device). The patients will also provide a spot urine specimen for ACR evaluation.
Visit 4 (V4): Visit 4 will be scheduled 1 day after visit 3. Patients will drop-off the Mobil-O-Graph device.
- Conditions
- Diabetes Mellitus
- Being tested
- Dapagliflozin, Placebo
- Keywords
- Dapagliflozin, Arterial Stiffness, Aortic Pressure
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga
Administration of dapagliflozin (film-coated tablet of 10mg, per os, q24h, 12 weeks)
PlaceboDrug
Administration of placebo (film-coated tablet of same color and texture with dapagliflozin, 10mg, per os, q24h, 12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Active comparator | Dapagliflozin for oral administration. Patients will be randomized in a 1:1 ratio to the dapagliflozin or placebo group. Receives: Drug: Dapagliflozin |
| Placebo | Placebo comparator | Placebo for oral administration. Patients will be randomized in a 1:1 ratio to the dapagliflozin or placebo group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory systolic aortic pressure
Measured: 12 weeks
Secondary outcomes (8)
Ambulatory aortic (central) diastolic blood pressure (DBP)
Measured: 12 weeks
Ambulatory brachial systolic blood pressure (SBP) and DBP
Measured: 12 weeks
Ambulatory augmentation index (AIx)
Measured: 12 weeks
Ambulatory pulse wave velocity (PWV)
Measured: 12 weeks
Office brachial SBP and DBP
Measured: 12 weeks
Albumin/creatinine ratio (ACR)
Measured: 12 weeks
Lipid profile (Total-Cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides)
Measured: 12 weeks
HbA1c
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2019
- Study completionOct 2019
Why it stopped: On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Society for Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pantelis Sarafidis, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887677
- Sponsor's protocol ID
- ESR-15-10964
- Status last verified
- Nov 2019
- First submitted
- 25 Aug 2016
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
PubMed 19896746Hu FB. Globalization of diabetes: the role of diet, lifestyle, and genes. Diabetes Care. 2011 Jun;34(6):1249-57. doi: 10.2337/dc11-0442.
PubMed 21617109Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444.
PubMed 25126392Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
PubMed 8366922Abdul-Ghani MA, Norton L, DeFronzo RA. Efficacy and safety of SGLT2 inhibitors in the treatment of type 2 diabetes mellitus. Curr Diab Rep. 2012 Jun;12(3):230-8. doi: 10.1007/s11892-012-0275-6.
PubMed 22528597Aylsworth A, Dean Z, VanNorman C, Nkemdirim Okere A. Dapagliflozin for the Treatment of Type 2 Diabetes Mellitus. Ann Pharmacother. 2014 Sep;48(9):1202-1208. doi: 10.1177/1060028014540450. Epub 2014 Jun 20.
PubMed 24951310Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009 Apr;58(4):773-95. doi: 10.2337/db09-9028. No abstract available.
PubMed 19336687Karagiannis A, Tziomalos K, Anagnostis P, Gossios TD, Florentin M, Athyros VG, Mikhailidis DP. The effect of antihypertensive agents on insulin sensitivity, lipids and haemostasis. Curr Vasc Pharmacol. 2010 Nov;8(6):792-803. doi: 10.2174/157016110793563906.
PubMed 20626344Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.
PubMed 22517736Pandey R, Kumar N, Yadav M, Nagpal R, Jain S, Yadav H. Anti-diabetic compounds and their patent information: an update. Recent Pat Inflamm Allergy Drug Discov. 2013 Jan 1;7(1):35-48.
PubMed 23016523Karagiannis T, Paschos P, Paletas K, Matthews DR, Tsapas A. Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis. BMJ. 2012 Mar 12;344:e1369. doi: 10.1136/bmj.e1369.
PubMed 22411919Hoerger TJ, Segel JE, Gregg EW, Saaddine JB. Is glycemic control improving in U.S. adults? Diabetes Care. 2008 Jan;31(1):81-6. doi: 10.2337/dc07-1572. Epub 2007 Oct 12.
PubMed 17934153Xu X, Wang G, Zhou T, Chen L, Chen J, Shen X. Novel approaches to drug discovery for the treatment of type 2 diabetes. Expert Opin Drug Discov. 2014 Sep;9(9):1047-58. doi: 10.1517/17460441.2014.941352. Epub 2014 Jul 23.
PubMed 25054271Tasyurek HM, Altunbas HA, Balci MK, Sanlioglu S. Incretins: their physiology and application in the treatment of diabetes mellitus. Diabetes Metab Res Rev. 2014 Jul;30(5):354-71. doi: 10.1002/dmrr.2501.
PubMed 24989141DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: a new path towards normalizing glycaemia. Diabetes Obes Metab. 2012 Jan;14(1):5-14. doi: 10.1111/j.1463-1326.2011.01511.x.
PubMed 21955459
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02887677
- Acronym / sponsor ID
- ESR-15-10964
- Conditions
- Diabetes Mellitus
- Keywords
- Dapagliflozin, Arterial Stiffness, Aortic Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hellenic Society for Medical EducationUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 2 Sep 2016 (estimated)
- 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 is designed to test the hypothesis that the treatment-induced reductions in the ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the group of placebo.
It is a 12 week, double-blind, randomized, placebo-controlled clinical trial of dapagliflozin versus placebo in 160 adult patients with type 2 diabetes mellitus (DM). It will be conducted in three centers.
Potentially eligible patients will be asked to provide written informed consent (Screening Visit). Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit the sites one week (Visit 1 - V1) after the screening visit. On Visit 2 (V2) all eligible patients will be randomized to one of the two treatment arms and will continue with the next visits as appropriate (Visit 3, Telephone Visit 1, Visit 4-end of study).
Aortic blood pressure (BP) and arterial stiffness parameters will be measured as indicated by the protocol in V1 and V3 with the Mobil-O-Graph monitor.
Blood samples will be collected as indicated by the protocol in Screening Visit for the measurement of glycated hemoglobin (HbA1c), creatinine and liver function parameters. In addition, blood samples will be collected in V1 and V3 for routine hematological and biochemical tests including creatinine, fasting glucose, HbA1c, lipid profile and liver function parameters.
Urine samples will be collected as indicated by the protocol in V1 and V3 for the measurement of albumin to creatinine ratio.
Detailed description
Study design
Screening visit: Potentially eligible patients will be asked to provide written informed consent. The investigators will record full medical history, clinical examination, demographic characteristics, electrocardiogram (ECG), body weight, height, body mass index (BMI) and waist perimeter. Office blood pressure (BP) will be measured by the physicians three times using a mercury sphygmomanometer [cuffs will be placed at the level of brachial artery and a three minute interval will intercept each measurement, following 10 minutes of rest in the seated position (the cuff will cover at least 80% of the brachial circumference and 2/3 of the brachial length.)]. The investigators will also collect blood samples to determine glycated hemoglobin (HbA1C), creatinine, glomerular filtration rate (GFR) and liver function.
Visit 1 (V1): Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit the sites 1 week after the screening visit (+/-2 days), following a 12-hour fast. Three measurements of office BP at the level of brachial artery, with a three minutes interval between each measurement, will be performed with the use of a mercury sphygmomanometer, after 10 minutes-rest in the sitting posture (cuff with bladder size encircling at least 80% of arm circumference and covering two thirds of arm length). After that, venous blood specimens and a spot urine specimen will be collected for relevant blood tests and albumin/creatinine ratio (ACR) respectively. Subsequently, the Mobil-O-Graph monitor with a cuff of appropriate size will be fitted and the BP recording will be initiated for 24 hours. The device will be programmed to collect data every 20 minutes, except for 23:00 to 07:00 (data collection every 30 minutes).
Visit 2 (V2): An appointment will be scheduled the following day for the patient to drop-off the Mobil-O-Graph device. Patients will be randomized in a 1:1 ratio to the dapagliflozin or placebo group and will start receiving the drug regimen the same day. Moreover, all patients will receive dietary and lifestyle advice commencing from this visit.
Telephone Visit 1 (ΤV1): A telephone visit (TV1) will be scheduled 6 weeks after V2 (+/-2 days). Patient history will be obtained, emphasizing on possible adverse events during the previous 6 weeks. Home blood glucose levels, if available, would be also discussed.
Visit 3 (V3): Visit 3 will be scheduled 6 weeks after telephone visit 1 (TV1) (+/-2 days). The following parameters will be determined: medical history of the last weeks, clinical examination (including three brachial BP measurements with a mercury sphygmomanometer as mentioned before), venous blood specimen collection (under 12-hour fast) and the initiation of 24-hour ambulatory blood pressure monitoring (ABPM) (Mobil-O-Graph device). The patients will also provide a spot urine specimen for ACR evaluation.
Visit 4 (V4): Visit 4 will be scheduled 1 day after visit 3. Patients will drop-off the Mobil-O-Graph device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Active comparator | Drug: DapagliflozinDapagliflozin for oral administration. Patients will be randomized in a 1:1 ratio to the dapagliflozin or placebo group. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for oral administration. Patients will be randomized in a 1:1 ratio to the dapagliflozin or placebo group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 and ≤75 years old
- Type 2 diabetes mellitus
- Glycated hemoglobin ≥7% and ≤ 9%
- Patients on monotherapy or combination of two of the following type of antidiabetic agents :metformin, sulphonylurea,DPP-4 inhibitor,or insulin for the past 3 months.
- Patient to provide informed consent
Key exclusion criteria (15 listed)
- Hypovolemic patients.
- Patients on loop diuretics.
- Patients with low BP (office SBP <110 mmHg) or orthostatic hypotension (BP drop >20 mmHg and SBP <110 mmHg in standing position at 1 min).
- Patients on GLP-1 receptor agonist or pioglitazone.
- Secondary hypertension.
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: ForxigaAdministration of dapagliflozin (film-coated tablet of 10mg, per os, q24h, 12 weeks) | Drug | Dapagliflozin |
| PlaceboAdministration of placebo (film-coated tablet of same color and texture with dapagliflozin, 10mg, per os, q24h, 12 weeks). | Drug | Placebo |
Primary outcome
Ambulatory systolic aortic pressure
Time frame: 12 weeks
8 secondary outcomes
Ambulatory aortic (central) diastolic blood pressure (DBP)
Time frame: 12 weeks
Ambulatory brachial systolic blood pressure (SBP) and DBP
Time frame: 12 weeks
Ambulatory augmentation index (AIx)
Time frame: 12 weeks
Ambulatory pulse wave velocity (PWV)
Time frame: 12 weeks
Office brachial SBP and DBP
Time frame: 12 weeks
Albumin/creatinine ratio (ACR)
Time frame: 12 weeks
Lipid profile (Total-Cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides)
Time frame: 12 weeks
HbA1c
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: On February 2019 Astra-Zeneca Greece decided to stop the financial support of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Background: PubMed 19896746Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
- Background: PubMed 21617109Hu FB. Globalization of diabetes: the role of diet, lifestyle, and genes. Diabetes Care. 2011 Jun;34(6):1249-57. doi: 10.2337/dc11-0442.
- Background: PubMed 25126392Martin-Timon I, Sevillano-Collantes C, Segura-Galindo A, Del Canizo-Gomez FJ. Type 2 diabetes and cardiovascular disease: Have all risk factors the same strength? World J Diabetes. 2014 Aug 15;5(4):444-70. doi: 10.4239/wjd.v5.i4.444.
- Background: PubMed 8366922Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
- Background: PubMed 22528597Abdul-Ghani MA, Norton L, DeFronzo RA. Efficacy and safety of SGLT2 inhibitors in the treatment of type 2 diabetes mellitus. Curr Diab Rep. 2012 Jun;12(3):230-8. doi: 10.1007/s11892-012-0275-6.
- Background: PubMed 24951310Aylsworth A, Dean Z, VanNorman C, Nkemdirim Okere A. Dapagliflozin for the Treatment of Type 2 Diabetes Mellitus. Ann Pharmacother. 2014 Sep;48(9):1202-1208. doi: 10.1177/1060028014540450. Epub 2014 Jun 20.
- Background: PubMed 19336687Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009 Apr;58(4):773-95. doi: 10.2337/db09-9028. No abstract available.
- Background: PubMed 20626344Karagiannis A, Tziomalos K, Anagnostis P, Gossios TD, Florentin M, Athyros VG, Mikhailidis DP. The effect of antihypertensive agents on insulin sensitivity, lipids and haemostasis. Curr Vasc Pharmacol. 2010 Nov;8(6):792-803. doi: 10.2174/157016110793563906.
- Background: PubMed 22517736Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.
- Background: PubMed 23016523Pandey R, Kumar N, Yadav M, Nagpal R, Jain S, Yadav H. Anti-diabetic compounds and their patent information: an update. Recent Pat Inflamm Allergy Drug Discov. 2013 Jan 1;7(1):35-48.
- Background: PubMed 22411919Karagiannis T, Paschos P, Paletas K, Matthews DR, Tsapas A. Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis. BMJ. 2012 Mar 12;344:e1369. doi: 10.1136/bmj.e1369.
- Background: PubMed 17934153Hoerger TJ, Segel JE, Gregg EW, Saaddine JB. Is glycemic control improving in U.S. adults? Diabetes Care. 2008 Jan;31(1):81-6. doi: 10.2337/dc07-1572. Epub 2007 Oct 12.
- 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.
Pantelis Sarafidis principal investigator
Aristotle University Of Thessaloniki
3 sites 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 Diabetes Mellitus, run by Hellenic Society for Medical Education at 3 sites in Greece.
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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. 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 was stopped early (reason given: On February 2019 Astra-Zeneca Greece decided to stop the financial support of the 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?
Ambulatory systolic aortic pressure (time frame: 12 weeks). 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 NCT02887677, which also lists 53 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 3 Dec 2019.