A Phase 4 interventional study of Dapagliflozin in Diabetes Mellitus, Type 2 and Skeletal Muscle Insulin Sensitivity, sponsored by AstraZeneca. Completed at 1 site in Netherlands. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-15.
Sponsored by AstraZeneca · Phase 4, Interventional, and Basic science
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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 153rd largest by enrollment, is one of 10 that started in 2018, is one of 77 in phase 4, and was the 103rd 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 70 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 26 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 236th 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 291st 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.
The purpose of this study is to investigate the effects of 5 weeks treatment with dapagliflozin in type 2 diabetes patients on how the hormone insulin acts on sugar uptake in muscles.
To investigate if dapagliflozin improves skeletal muscle insulin sensitivity expressed as corrected glucose disposal rate (cGDR) in comparison with placebo after 5-week double blind treatment. Insulin sensitivity will be determined using a 2-step euglycemic hyperinsulinemic clamp (EHC) procedure
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 contra-indication to magnetic resonance imaging scanning. These contra-indications include patients with following devices:
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Patients will receive dapagliflozin 10 mg in tablet for a maximum of 40 days based on randomization sequence in Period 1. Patients that received 10 mg dapagliflozin in the first treatment period will receive matching placebo in the second treatment period for a maximum of 40 days.
Drug: Dapagliflozin
Patients will receive matching placebo in tablet for a maximum of 40 days based on randomization sequence. Patients who received placebo in the first treatment will receive 10 mg dapagliflozin in the second treatment period, for a maximum of 40 days
Drug: Dapagliflozin
The study consist of 5 weeks treatment period 1, 6-8 weeks wash-out period and 5 weeks treatment period 2. The patient will be administered dapagliflozin 10 mg during Period 1 or Period 2.
Corrected Glucose Disposal Rate (cGDR) Measured as Change in Rate of Disposal (Delta RD) Basal vs High Insulin After 5 Weeks of Treatment
Skeletal muscle insulin sensitivity was measured as cGDR (referred to as delta RD \[basal vs high insulin\]) using a 2-step 5.5 hour euglycemic hyperinsulinemic clamp (EHC) procedure in combination with infusion of D-glucose (6,6-D2) glucose. Delta RD (basal vs high insulin) was corrected for urinary glucose excretion and measured at the end of Treatment Periods 1 and 2.
Time frame: At end (Week 5) of Treatment Periods 1 and 2
Change in Endogenous Glucose Production (EGP) After 5 Weeks of Treatment
A 2-step 5.5 hour EHC in combination with infusion of 6,6-D2 glucose was used to determine rates of EGP at the end of Treatment Periods 1 and 2. Results of the change in EGP are presented as delta EGP (basal vs low insulin and basal vs high insulin).
Time frame: At end (Week 5) of Treatment Periods 1 and 2
Change in Respiratory Exchange Ratio (RER) From Fasted State to Insulin Stimulated State After 5 Weeks of Treatment
During the indirect calorimetry of the EHC test, respiratory gas exchange was measured using open air circuit respirometry with an automated ventilated hood system. Metabolic flexibility was determined by the change in RER from fasted state to insulin stimulated state at the end of Treatment Periods 1 and 2 and results are presented as delta RER (basal vs high insulin).
Time frame: At end (Week 5) of Treatment Periods 1 and 2
24-Hour RER After 5 Weeks of Treatment
RER was measured before and after meals over a 24-hour period.
Time frame: At end (Week 5) of Treatment Periods 1 and 2
24-Hour Energy Expenditure After 5 Weeks of Treatment
Whole body energy expenditure was measured over a 24-hour period.
Time frame: At end (Week 5) of Treatment Periods 1 and 2
Body Composition (Fat Mass and Lean Mass) After 5 Weeks of Treatment
On Day 6, 7 or 8 of the end of treatment visit in both treatment periods, a Dual-energy X-ray absorptiometry (DEXA) scan was used to determine body composition.
Time frame: At end (Week 5) of Treatment Periods 1 and 2
Body Composition (Total Mass) After 5 Weeks of Treatment
On Day 6, 7 or 8 of the end of treatment visit in both treatment periods a DEXA scan was used to determine body composition.
Time frame: At end (Week 5) of Treatment Periods 1 and 2
Fibroblast Growth Factor 21 (FGF21) Area Under the Curve (AUC) in Plasma After 5 Weeks of Treatment
From the end of Day 1 until the morning of Day 3 of the end of each treatment visit, the patients stayed in the metabolic chamber (36 hours). During this stay FGF21 was measured in plasma before and after meals and before bed-time to determine the AUC (last 24 hours).
Time frame: At end (Week 5) of Treatment Periods 1 and 2
This was a double-blind, randomized, placebo-controlled, cross-over Phase IV mechanistic study which was conducted in 1 study center in the Netherlands between 05 March 2018 and 04 November 2019.
| Milestone | Dapagliflozin 10 mg Then Placebo | Placebo Then Dapagliflozin 10 mg |
|---|---|---|
| Started | 12 | 14 |
| Received treatment in period 1 | 12 | 14 |
| Received treatment in period 2 | 11 | 14 |
| Completed | 11 | 14 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawn as birth control pill stopped | 1 | 0 |
Skeletal muscle insulin sensitivity was measured as cGDR (referred to as delta RD \[basal vs high insulin\]) using a 2-step 5.5 hour euglycemic hyperinsulinemic clamp (EHC) procedure in combination with infusion of D-glucose (6,6-D2) glucose. Delta RD (basal vs high insulin) was corrected for urinary glucose excretion and measured at the end of Treatment Periods 1 and 2.
| micromole/kilogram body weight/minute | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Corrected Glucose Disposal Rate (cGDR) Measured as Change in Rate of Disposal (Delta RD) Basal vs High Insulin After 5 Weeks of Treatment | 8.523 (5.566 to 11.481) | 9.592 (6.634 to 12.549) |
A 2-step 5.5 hour EHC in combination with infusion of 6,6-D2 glucose was used to determine rates of EGP at the end of Treatment Periods 1 and 2. Results of the change in EGP are presented as delta EGP (basal vs low insulin and basal vs high insulin).
| micromole/kilogram body weight/minute | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Delta EGP (basal vs low insulin) | -4.656 (-5.494 to -3.817) | -2.591 (-3.790 to -2.112) |
| Delta EGP (basal vs high insulin) | -10.803 (-11.726 to -9.880) | -8.512 (-9.435 to -7.589) |
During the indirect calorimetry of the EHC test, respiratory gas exchange was measured using open air circuit respirometry with an automated ventilated hood system. Metabolic flexibility was determined by the change in RER from fasted state to insulin stimulated state at the end of Treatment Periods 1 and 2 and results are presented as delta RER (basal vs high insulin).
| ratio | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Change in Respiratory Exchange Ratio (RER) From Fasted State to Insulin Stimulated State After 5 Weeks of Treatment | 0.101 (0.080 to 0.122) | 0.089 (0.068 to 0.110) |
RER was measured before and after meals over a 24-hour period.
| ratio | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| 24-Hour RER After 5 Weeks of Treatment | 0.812 (0.803 to 0.821) | 0.835 (0.826 to 0.844) |
Whole body energy expenditure was measured over a 24-hour period.
| megajoules/day | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| 24-Hour Energy Expenditure After 5 Weeks of Treatment | 9.519 (9.017 to 10.020) | 9.628 (9.126 to 10.130) |
On Day 6, 7 or 8 of the end of treatment visit in both treatment periods, a Dual-energy X-ray absorptiometry (DEXA) scan was used to determine body composition.
| grams | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Fat Mass | 25318.3 (22978.4 to 27658.1) | 25564.9 (23225.0 to 27904.8) |
| Lean Mass | 59929.0 (56762.1 to 63095.8) | 60595.4 (57428.5 to 63762.3) |
On Day 6, 7 or 8 of the end of treatment visit in both treatment periods a DEXA scan was used to determine body composition.
| kilograms | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Body Composition (Total Mass) After 5 Weeks of Treatment | 85.248 (81.608 to 88.888) | 86.504 (82.864 to 90.143) |
From the end of Day 1 until the morning of Day 3 of the end of each treatment visit, the patients stayed in the metabolic chamber (36 hours). During this stay FGF21 was measured in plasma before and after meals and before bed-time to determine the AUC (last 24 hours).
| nanograms/liter/hour | Dapagliflozin 10 mg | Placebo |
|---|---|---|
| Fibroblast Growth Factor 21 (FGF21) Area Under the Curve (AUC) in Plasma After 5 Weeks of Treatment | 3310.415 (2626.919 to 3993.911) | 3554.716 (2871.270 to 4238.212) |
Collected over Adverse events (AEs) were reported throughout the treatment period and including the follow-up period. Overall time frame up to a maximum of 19 weeks (including both 5-week treatment periods, 6-8 weeks wash-out and 5-10 days safety follow-up after last dose of study drug).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dapagliflozin 10mg | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Placebo | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
Randomized analysis set consisted of all randomized patients.
| Age, Continuous(years) | Dapagliflozin 10 mg Then Placebo | Placebo Then Dapagliflozin 10 mg | Total |
|---|---|---|---|
| Mean | 63.0 ± 4.7 | 64.4 ± 4.7 | 63.8 ± 4.7 |
| Sex: Female, Male(Participants) | Dapagliflozin 10 mg Then Placebo | Placebo Then Dapagliflozin 10 mg | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 7 | 13 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Dapagliflozin 10 mg Then Placebo | Placebo Then Dapagliflozin 10 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 14 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dapagliflozin 10 mg Then Placebo | Placebo Then Dapagliflozin 10 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 12 | 14 | 26 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Nov 2019, 19 months.
Results were first posted in Jan 2021, 1 year 2 months 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 19 months is close to 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 Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin