A Phase 4 interventional study of dapagliflozin and placebo in Diabetes Mellitus Type 2, sponsored by AstraZeneca. Completed at 2 sites in 2 countries. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
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Among 180 studies testing dapagliflozin in Diabetes Mellitus, Type 2 — 15 open to participants now, 19 under way, 5 of them phase 3. dapagliflozin · Diabetes Mellitus, Type 2.
Among the 180 studies testing dapagliflozin in Diabetes Mellitus, Type 2, this one is the 116th largest by enrollment, is one of 10 that started in 2018, is one of 77 in phase 4, and was the 106th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →15 of the 180 studies testing dapagliflozin in Diabetes Mellitus, Type 2 are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Argentina, China and 10 more countries
Ages 18+
AstraZeneca · Sites in United States, Argentina, Brazil and 21 more countries
Ages 18+
Junjie Yang · Sites in China
Ages 18–78
Herlev and Gentofte Hospital · Sites in Denmark
Ages 18+
University Health Network, Toronto · Sites in Canada
Ages 18+
By country, each count listing its studies:
dapagliflozin: first FDA approval 2014 (FARXIGA), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 40 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
180 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 21 · Phase 3 53 · Phase 4 77
First in 2005; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 53 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 82 across the 180 interventional studies. Of the 136 that completed or were terminated, 68 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
82 of 180 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
345 studies in Diabetes Mellitus, Type 2 by AstraZeneca: 13 open now, 15 under way, 9 of them phase 3. Of 325 finished, 149 (46%) have results posted.
Among the 345 studies in Diabetes Mellitus, Type 2 by AstraZeneca, this one is the 188th largest by enrollment of the 280 interventional ones that give a count, is one of 9 that started in 2018, is one of 28 in phase 4, and was the 295th registered.
AstraZeneca’s Diabetes Mellitus, Type 2 studies by the year they started, since 2001.
6 of the studies testing dapagliflozin in Diabetes Mellitus, Type 2 that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07311551Bhavya Bhavya, MDA Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI) | 2026-12 |
| NCT02969798The University of Texas Health Science Center at San AntonioPre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT) | 2027-02-28 |
| NCT07614230Junjie YangSGLT2 Inhibitors on Coronary Atherosclerosis Progression Via Perivascular Adipose Tissue in Diabetes | 2027-06-01 |
| NCT07891234Sherihan AboElyazed Mohamed KhalilEffect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance | 2027-10-01 |
| NCT05938712University Health Network, TorontoThe Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients | 2027-10-01 |
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Among the 180 studies testing dapagliflozin in Diabetes Mellitus, Type 2, from their registry updates:
Among AstraZeneca’s 345 in Diabetes Mellitus, Type 2:
This tab as a report to print or save as PDF → With an account.
This is a randomised, placebo-controlled, double-blind, parallel-group, international, multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo once daily and treated for six weeks. The study includes five visits.
The following will be assessed at Baseline and at the end of the treatment period;
CT-PET scanning will be made to assess myocardial function and metabolism, as well as fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least 6 hours at the same time of day at all visits.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following cardiovascular diseases known within 3 months prior to signing the consent at enrolment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
placebo tablets once daily
Drug: placebo
dapagliflozin 10mg tablets once daily
Drug: dapagliflozin
dapagliflozin 10mg
Also known as: Forxiga 10mg
placebo to match dapagliflozin
Adjusted Mean Change From Baseline in Global Longitudinal Strain of the Left Ventricle (GLSLV) at End of Treatment.
Patients underwent magnetic resonance imaging (MRI) examination to determine the GLSLV, which is expressed as a percentage. The least square mean (LSM) change from baseline estimates were generated from an analysis of covariance (ANCOVA) model with treatment and baseline value of the endpoint as covariates.
Time frame: Baseline (Day 1) and end of treatment (Day 42)
Adjusted Mean Change From Baseline in Myocardial Efficiency at End of Treatment.
A clinical radiologic assessment of acquired computed tomography and positron emission tomography (CTPET)-\[11C\]-acetate images was performed to determine myocardial efficiency. The myocardial efficiency calculation was based on an estimate of energy used for producing LV contractile work (mean arterial pressure (MAP) x stroke volume (SV) x heart rate (HR) / myocardial mass) compared to the total cardiac work (calculated based on the total myocardial oxygen consumption per myocardial mass) and is expressed as a percentage. The LSM change from baseline estimates, were generated from an ANCOVA model with treatment and baseline value of the endpoint as covariates.
Time frame: Baseline (Day 1) and end of treatment (Day 42)
Fifty three patients with type 2 diabetes and on a stable dose of metformin for at least 6 weeks were enrolled in 1 study center in Sweden and 1 center in Finland. The first patient was enrolled on 28 February 2018 and the last patient's last visit was on 19 March 2019.
| Milestone | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Started | 27 | 26 |
| Completed | 25 | 26 |
| Not completed | 2 | 0 |
| Withdrew: In receipt of disallowed medication | 1 | 0 |
| Withdrew: Did not receive treatment | 1 | 0 |
Patients underwent magnetic resonance imaging (MRI) examination to determine the GLSLV, which is expressed as a percentage. The least square mean (LSM) change from baseline estimates were generated from an analysis of covariance (ANCOVA) model with treatment and baseline value of the endpoint as covariates.
| Percentage of GLSLV | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Adjusted Mean Change From Baseline in Global Longitudinal Strain of the Left Ventricle (GLSLV) at End of Treatment. | 0.30769 (-0.35001 to 0.96538) | -0.00352 (-0.66121 to 0.65417) |
A clinical radiologic assessment of acquired computed tomography and positron emission tomography (CTPET)-\[11C\]-acetate images was performed to determine myocardial efficiency. The myocardial efficiency calculation was based on an estimate of energy used for producing LV contractile work (mean arterial pressure (MAP) x stroke volume (SV) x heart rate (HR) / myocardial mass) compared to the total cardiac work (calculated based on the total myocardial oxygen consumption per myocardial mass) and is expressed as a percentage. The LSM change from baseline estimates, were generated from an ANCOVA model with treatment and baseline value of the endpoint as covariates.
| Percentage of Myocardial Efficiency | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Adjusted Mean Change From Baseline in Myocardial Efficiency at End of Treatment. | -0.71474 (-3.74654 to 2.31706) | -2.46443 (-5.49623 to 0.56737) |
Collected over Adverse events (AEs) were collected from start of treatment until 1 week after end of treatment (Day 1 to Day 49).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dapagliflozin 10 mg | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Placebo | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Customized(Participants) | Dapagliflozin 10 mg | Placebo | Total |
|---|---|---|---|
| <65 years | 12 | 11 | 23 |
| ≥65 years | 15 | 15 | 30 |
| Sex: Female, Male(Participants) | Dapagliflozin 10 mg | Placebo | Total |
|---|---|---|---|
| Female | 8 | 15 | 23 |
| Male | 19 | 11 | 30 |
| Race/Ethnicity, Customized(Participants) | Dapagliflozin 10 mg | Placebo | Total |
|---|---|---|---|
| White | 27 | 26 | 53 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Mar 2019, 12 months.
Results were first posted in Mar 2020, 1 year after primary completion.
Of 132 industry-sponsored phase 4 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's 12 months is below that.
Counting every sponsor, half of 452 studies reached it within 24 months; a quarter within 13 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin