A Phase 4 interventional study of Dapagliflozin (Forxiga®) and Hydrochlorothiazide 25 mg in Type 2 Diabetes Mellitus (T2DM), sponsored by University Hospital Tuebingen. Withdrawn at 1 site in Germany. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by University Hospital Tuebingen · 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 179th largest by enrollment, is one of 12 that started in 2021, 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 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. 12 started in 2021.
By drug class, each counting the studies that test any of its medicines:
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:
University Hospital Tuebingen is the lead sponsor of 491 studies on the registry; 109 are open to participants now.
14 studies in Diabetes Mellitus, Type 2 by University Hospital Tuebingen: 2 open now, 4 under way, none of them phase 3. Of 8 finished, 0 (0%) have results posted.
Among the 14 studies in Diabetes Mellitus, Type 2 by University Hospital Tuebingen, this one is the 11th largest by enrollment of the 12 interventional ones that give a count, is one of 4 that started in 2021, is one of 4 in phase 4, and was the 6th registered.
University Hospital Tuebingen’s Diabetes Mellitus, Type 2 studies by the year they started, since 2007.
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 University Hospital Tuebingen’s 14 in Diabetes Mellitus, Type 2:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Dapagliflozin effect on erythropoiesis and physical fitness in patients with type 2 diabetes - a randomized, partly double-blinded, controlled, three armed, parallel group, exploratory study
Many patients with diabetes present with hyperglycemia, hypertension, hypercholesterolemia and excess weight, which are associated with micro- and macrovascular complications. Therapies to alleviate the burden of these complications have traditionally focused on reducing glycemia and optimizing blood pressure and cholesterol concentration. However, despite the various available treatment options to improve glycemic control, many patients do not reach treatment and lifestyle targets, such as improving physical fitness. Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the proximal tubule reabsorption of filtered glucose, thereby causing glucosuria and decreasing plasma glucose concentrations. When large quantities of glucose are pharmacologically forced into urinary excretion, whole-body metabolism undergoes adaptive changes, involving glucose fluxes, hormonal responses, fuel selection, and energy expenditure. SGLT2 inhibitors have been proven to be superior to conventional therapy by reducing cardiovascular mortality in patients with cardiovascular diseases (CVD). Many of the explained mechanisms contribute to this effect, and other, still unknown factors, need to be identified.
In the present study, patients suffering from T2DM and hypertension will be treated with Dapagliflozin, an SGLT2 inhibitor, or matching Placebo, or HCT as reference drug with a diuretic and anti-hypertensive effect.
There is evidence that SGLT2 inhibition positively affects the erythropoietin-RBC axis. By this mechanism, Dapagliflozin improves oxygen supply to tissues, an effect which can explain the positive cardiovascular (CV) outcome data of Dapagliflozin in recent registry data. The aim of the present study is to provide clinical endpoints related to this effect. Specifically, the effect of Dapagliflozin on erythropoietin, reticulocytes, and HIF related factors will be studied and related to physical fitness before and after treatment with Dapagliflozin. Providing evidence for an improvement in physical fitness and cardiac function by Dapagliflozin will be of great clinical benefit in patients with T2DM, since a large number of these patients have reduced physical activity and heart failure. The increasing effect of SGLT2 inhibitors on hematocrit was initially attributed to a relative hemoconcentration due to the diuretic effect elicited by the drug. However, studies comparing Dapagliflozin directly to diuretic treatment with HCT showed that the effect of Dapagliflozin was superior to diuretic treatment with HCT. Moreover, Dapagliflozin, and not HCT, also increased reticulocytes count and EPO concentrations [1]. Together, these data suggest that hemoconcentration is not mediating the effect of Dapagliflozin on hemopoiesis and that other mechanisms must contribute. Yet, reducing preload by diuretic properties may beneficially affect physical performance and may, thus, affect the secondary endpoint. Therefore, three treatments will be used in this study: Dapagliflozin and matching placebo, and HCT as reference treatment for the diuretic effect.
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:
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.
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.
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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
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.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, 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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
Treatment with the SGLT2 inhibitor dapagliflozin 10 mg once daily for 28 days.
Drug: Dapagliflozin (Forxiga®)
Treatment with the Dapagliflozin matching placebo once daily for 28 days.
Drug: Placebo matching Dapagliflozin
Treatment with the Hydrochlorothiazide 25 mg once daily for 28 days
Drug: Hydrochlorothiazide 25 mg
10mg p.o. daily
25mg p.o. daily
Placebo matching Dapagliflozin p.o. daily
Change in blood EPO levels
The primary objective is to investigate the change in erythropoietin (EPO) levels after 2 weeks of treatment with dapagliflozin in comparison to treatment with placebo.
Time frame: 2 weeks of treatment
Change in physical fitness
Change in physical fitness between baseline and EoT as assessed by spiroergometry (VO2max, heart rate and blood pressure) with dapagliflozin in comparison to treatment with placebo
Time frame: 4 weeks of treatment
Change in reticulocyte concentration, hematocrit and red blood cells
Change in reticulocyte concentration, hematocrit and red blood cells between baseline and after 2 and 4 weeks of treatment with dapagliflozin in comparison to treatment with placebo
Time frame: baseline, 2 weeks and 4 weeks of treatment
Change in hepcidin
Change in hepcidin between baseline and EoT with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change in blood EPO levels
Change in blood EPO levels between baseline and EoT (comparison dapagliflozin vs HCT vs placebo)
Time frame: baseline, 4 weeks of treatment
Change in iron status (Fe)
Change in iron status between baseline and EoT as measured by Fe with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change in iron status (Ferritin)
Change in iron status between baseline and EoT as measured by ferritin with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change in iron status (Transferrin)
Change in iron status between baseline and EoT as measured by transferrin with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change in catecholamine (adrenalin)
Change in adrenalin concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change in catecholamine (noradrenalin)
Change in noradrenalin concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change in catecholamine (metabolites metanephrine)
Change in metabolites metanephrine concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change in catecholamine (normetanephrine)
Change in normetanephrine concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change in steroid hormone
Change in steroid hormone concentrations between baseline and EoT with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change of ejection fraction
Change of ejection fraction measured by echocardiography, between baseline and EoT with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Change of diastolic function parameters
Change of diastolic function parameters measured by echocardiography, between baseline and EoT with dapagliflozin in comparison to treatment with placebo
Time frame: baseline and 4 weeks of treatment
Start is estimated for Sep 2021; primary completion for Mar 2023, 18 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dapagliflozin · Hydrochlorothiazide
University Hospital Tuebingen →