A Phase 4 interventional study of Dapagliflozin and Acarbose in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Terminated at 20 sites in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-12-07.
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 45th largest by enrollment, is one of 13 that started in 2017, is one of 77 in phase 4, and was the 104th 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: 18 Years to 100 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. 13 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 304 is above 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 103rd largest by enrollment of the 280 interventional ones that give a count, is one of 22 that started in 2017, is one of 28 in phase 4, and was the 292nd 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 |
Add all 6 to your calendar (.ics) → With an account.
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 24-week, multicenter, randomized, open-label, parallel-group, active controlled Phase IV study to assess the efficacy and safety of Dapagliflozin as monotherapy compared with Acarbose in patients with T2DM who were inadequately controlled with diet and exercise.
The study is designed to evaluate the efficacy and safety of dapagliflozin monotherapy compared with acarbose monotherapy in patients with T2DM inadequately controlled with diet and exercise.
The study is powered to show non-inferiority of dapagliflozin versus acarbose regarding with HbA1c reduction.
A non-inferiority margin of 0.25% for the difference of the reduction in HbA1c is considered in the study.
Acarbose will be started from 50 mg once a day at dinner during the first week and titrated up to 50 mg twice a day at lunch and dinner in the second week, 50 mg three times a day at three meals in the third week, and 100 mg three times a day from the fourth week onwards.
The dosing in study is in line with the local labels for dapagliflozin and acarbose.
Treatment duration of 24 weeks is considered to be adequate to establish glycemic efficacy of dapagliflozin monotherapy compared with acarbose monotherapy in lowering blood glucose indicated by HbA1c change in patients with T2DM inadequately controlled with diet and exercise.
Acarbose is the most widely used oral anti-diabetic drug in china. The common side effects of acarbose treatment are flatulence, borborygmus and diarrhoea, according to the prescribing information and clinical experience from physicians.
The treatment regimens in the study are in line the prescribing information for dapagliflozin and acarbose. Patients with potential contraindications or not considered to get benefit from dapagliflozin or acarbose treatment will be excluded from the study by the inclusion/exclusion criteria set in the study. And the patient safety will be closely monitored in the study by Adverse events/Serious Adverse events collecting and assessment, laboratory testing, ECG, glucometer, vital sign and physical examination.
Overall, the study drugs investigated and the study design is considered to have a favorable benefit-risk profile in the treatment of patients with T2DM.
Methods for assigning treatment groups A block stratified randomization method will be used to assign patients to the treatment groups in this study. Patients will be randomized 1:1 to treatment groups via a central randomization system (interactive voice / web response system [Interactive Voice Response System/Interactive Web Response System])(IVRS/IWRS), and drug will be dispensed accordingly.
The study population will be stratified based on the level of HbA1c at baseline (HbA1c \< 8.0%、≥ 8.0% \~ \< 9.0% and ≥9.0%)
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:
Diagnosis or history of:
a. Acute metabolic diabetic complications such as ketoacidosis or hyperglycemic hyperosmolar state b. Diabetes insipidus.
Patients with following renal disease history or renal disease related features:
Any of the following cardiovascular diseases within 6 months of the enrollment visit:
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.
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
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.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Dapagliflozin is started from 5 mg once a day, taken orally in the morning, before or after breakfast. From the third week, the dose will be increased to 10 mg once a day and last to the end of the study.
Drug: Dapagliflozin
Acarbose is started from 50 mg once a day at dinner during the first week, titrated up to 50 mg twice a day at lunch and dinner in the second week, 50 mg three times a day at three meals in the third week, and 100 mg three times a day till the end of the study.
Drug: Acarbose
Starting dose of dapagliflozin is 5 mg once daily, taken orally in the morning, before or after breakfast. From the third week,the dose can be increased to 10 mg once daily, and last to the end of the study.
Acarbose was started from 50 mg once a day at dinner during the first week and titrated up to 50 mg twice a day at lunch and dinner in the second week, 50 mg three times a day at three meals in the third week, and 100 mg three times a day till the end of the study.
Absolute change from baseline in HbA1c at Week 24
Which will be derived using the HbA1c (%) at week 24 minus HbA1c (%) at baseline.
Time frame: At week 24
Percentage of patients at Week 24 with reduction of HbA1c≥0.5%, body weight≥3% and SBP ≥3mmHg from baseline
Which will be derived using the number of patients who have reduction in HbA1c ≥ 5%, and body weight ≥3% and SBP ≥3 mmHg compared to baseline divided by the total number of patients.
Time frame: From baseline to week 24
Percentage of patients achieving HbA1c<7.0%
Which will be derived using the number of patient who have the HbA1c (%) \< 7.0% after 24 weeks treatment divided by the total number of patients.
Time frame: From baseline to week 24
Percentage of patients with reduction of HbA1c≥0.5%
Which will be derived using the number of patients who have reduction in HbA1c≥0.5% after 24 weeks compared to baseline divided by the total number of patients.
Time frame: From baseline to week 24
Absolute change from baseline in fasting plasma glucose (FPG)
Which will be derived using the value of fasting plasma glucose (FPG) at post-baseline visits minus the value at baseline
Time frame: From baseline to week 24
Absolute change from baseline in 2h postprandial glucose (PPG)
Which will be derived using the value of 2h postprandial glucose (PPG) at the post-baseline visits minus the value at baseline
Time frame: From baseline to week 24
Absolute change from baseline in body weight
Which will be derived using the value of the body weight at the post-baseline visits minus the value at baseline
Time frame: From baseline to week 24
Percentage of patients with reduction of body weight ≥3%
Which will be derived using the number of patients who have reduction in body weight≥3% after 24 weeks compared to baseline divided by the total number of patients.
Time frame: From baseline to week 24
Absolute change from baseline in systolic blood pressure (SBP)
Which will be derived using the value of the systolic blood pressure at the post-baseline visits minus the value at baseline
Time frame: From baseline to week 24
Percentage of patients with reduction of SBP ≥3 mmHg
Which will be derived using the number of patients who have reduction in SBP ≥3 mmHg after 24 weeks compared to baseline divided by the total number of patients.
Time frame: From baseline to week 24
Homeostasis model assessment-β
Which will be used to evaluate the beta cell function.
Time frame: From baseline to week 24
HOMA-IR
Which will be used to evaluate the insulin sensitivity
Time frame: From baseline to week 24
The difference of the number between tablets taken and tablets prescribed
Which will be derived using the number of tablets dispensed minus the number of tablets returned
Time frame: From baseline to week 24
Plan to share: No
Ran from Dec 2017 to primary completion in May 2019, 17 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin