Type 2 Diabetes Mellitus (T2DM)Phase 4NCT03423355
Dapagliflozin Effect on Erythropoiesis and Physical Fitness
A Phase 4 study testing Dapagliflozin (Forxiga®) and Hydrochlorothiazide 25 mg in people with Type 2 Diabetes Mellitus (T2DM), run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Dapagliflozin (Forxiga®) and Hydrochlorothiazide 25 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2021to Dec 2023
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged between 40 and 70 years (including)
- Diagnosis of type 2 diabetes mellitus (T2DM) with HbA1c between 7.1 10.0% (including)
- Stable treatment of type 2 diabetes, except with SGLT2-Inhibitors over the last 4 weeks
- Body mass index (BMI) between 25 kg/m2 and 35 kg/m2 (including)
- Blood pressure > 130/80 mmHg but 170/95 mmHg at maximum
- Ability to perform spiroergometry
Show all 9Show fewer
- Ability to understand and follow study-related instructions
- Negative pregnancy test
- Patients who are receiving the following medications must be on a stable treatment regimen for at least 2 months prior to the screening visit (V0): antihypertensive agents, thyroid replacement therapy, antidepressant agents
Who cannot join
- Diagnosis of Type 1 diabetes
- History of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced T2DM
- Repeated episodes of severe hypoglycaemia within the last 3 months prior to Screening
- Patients with significant thyroid disease
- Intention to change physical activity within the next 8 weeks
- Clinically significant cardiovascular disease (CVD) or procedure within 3 months prior to enrollment or expected to require coronary revascularization procedure
Show all 31Show fewer
- Presence of history of severe congestive heart failure (NYHA III and IV), pace maker or aortic stenosis (AS) > II
- eGFR (as calculated by the MDRD equation) < 60 ml/min/1.73 m2
- Unstable or rapidly progressing renal disease or anuria
- Concomitant medication with loop diuretics
- Any previous exposure to dapagliflozin or any other SGLT2-Inhibitor, or HCT within last 3 months prior to Screening
- Triglyceride concentrations ≥ 700 mg/dL (≥ 7.98 mmol/L) at the Screening visit (V0)
- History or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis
- History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded
- • Significant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) and/or total bilirubin (TB) > 2 mg/dL (> 34.2 μmol/L) (patients with TB > 2 mg/dL [> 34.2 μmol/L] and documented Gilbert's syndrome will be allowed to participate)
- Known human immunodeficiency virus (HIV) infection
- History of organ transplantation
- Malignancy (with the exception of basal and squamous cell carcinoma of the skin) within 5 years prior to the Screening visit (V1)
- • Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration < 12.0 g/dL) or any other condition known to interfere with the HbA1c methodology
- Patients who have donated blood or had a significant blood loss within 2 months of first dose of study medication or is planning to donate blood during the study
- Patients who have donated plasma within 7 days prior to first dose of study medication
- Systemic corticosteroids within 3 months prior to the Screening visit (V0) known to have a high rate of systemic absorption
- History of chronic obstructive pulmonary disease (COPD) or asthma
- Disabilities contraindicating spiroergometry
- Alcohol consumption > 20 g/day for women or > 30 g/day for men
- History of hypersensitivity to any of the study drugs or their ingredients
- Presence of psychiatric disorder or intake of anti-depressive or anti-psychotic agents with the exception of benzodiazepines and SSRIs/SNRI´s
- Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study
- Pregnant or breastfeeding women
- Subject (male or female) is not willing to use highly effective contraceptive methods during treatment and for 14 days (male or female) after the end of treatment (highly effective methods are defined as: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence). Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen, Otfried-Mueller Str. 10
Tübingen, 72076
About this study
Official title: 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
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
Read the detailed description
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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Dapagliflozin (Forxiga®), Hydrochlorothiazide 25 mg, Placebo matching Dapagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (Forxiga®)Drug
10mg p.o. daily
Hydrochlorothiazide 25 mgDrug
25mg p.o. daily
Placebo matching DapagliflozinDrug
Placebo matching Dapagliflozin p.o. daily
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin (Forxiga®) | Active comparator | Treatment with the SGLT2 inhibitor dapagliflozin 10 mg once daily for 28 days. Receives: Drug: Dapagliflozin (Forxiga®) |
| Placebo matching Dapagliflozin | Placebo comparator | Treatment with the Dapagliflozin matching placebo once daily for 28 days. Receives: Drug: Placebo matching Dapagliflozin |
| Hydrochlorothiazide | Other | Treatment with the Hydrochlorothiazide 25 mg once daily for 28 days Receives: Drug: Hydrochlorothiazide 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks of treatment
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline and 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study startSep 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: change in sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Model description
- Single center, prospective, randomized, double-blind, controlled, three-armed, parallel group, open-label reference group exploratory study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423355
- Sponsor's protocol ID
- DapaFIT
- Status last verified
- Jul 2021
- First submitted
- 18 Dec 2017
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03423355
- Acronym / sponsor ID
- DapaFIT
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: change in sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Feb 2018 (actual)
- 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.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single center, prospective, randomized, double-blind, controlled, three-armed, parallel group, open-label reference group exploratory study
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin (Forxiga®) | Active comparator | Drug: Dapagliflozin (Forxiga®)Treatment with the SGLT2 inhibitor dapagliflozin 10 mg once daily for 28 days. |
| Placebo matching Dapagliflozin | Placebo comparator | Drug: Placebo matching DapagliflozinTreatment with the Dapagliflozin matching placebo once daily for 28 days. |
| Hydrochlorothiazide | Other | Drug: Hydrochlorothiazide 25 mgTreatment with the Hydrochlorothiazide 25 mg once daily for 28 days |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients aged between 40 and 70 years (including)
- Diagnosis of type 2 diabetes mellitus (T2DM) with HbA1c between 7.1 10.0% (including)
- Stable treatment of type 2 diabetes, except with SGLT2-Inhibitors over the last 4 weeks
- Body mass index (BMI) between 25 kg/m2 and 35 kg/m2 (including)
- Blood pressure > 130/80 mmHg but 170/95 mmHg at maximum
Key exclusion criteria (31 listed)
- Diagnosis of Type 1 diabetes
- History of diabetic ketoacidosis, hyperosmolar coma or corticosteroid-induced T2DM
- Repeated episodes of severe hypoglycaemia within the last 3 months prior to Screening
- Patients with significant thyroid disease
- Intention to change physical activity within the next 8 weeks
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 |
|---|---|---|
| Dapagliflozin (Forxiga®)10mg p.o. daily | Drug | Dapagliflozin (Forxiga®) |
| Hydrochlorothiazide 25 mg25mg p.o. daily | Drug | Hydrochlorothiazide |
| Placebo matching DapagliflozinPlacebo matching Dapagliflozin p.o. daily | Drug | Placebo matching Dapagliflozin |
Primary outcome
Change in blood EPO levels
Time frame: 2 weeks of treatment
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.
14 secondary outcomes
Change in physical fitness
Time frame: 4 weeks of treatment
Change in reticulocyte concentration, hematocrit and red blood cells
Time frame: baseline, 2 weeks and 4 weeks of treatment
Change in hepcidin
Time frame: baseline and 4 weeks of treatment
Change in blood EPO levels
Time frame: baseline, 4 weeks of treatment
Change in iron status (Fe)
Time frame: baseline and 4 weeks of treatment
Change in iron status (Ferritin)
Time frame: baseline and 4 weeks of treatment
Change in iron status (Transferrin)
Time frame: baseline and 4 weeks of treatment
Change in catecholamine (adrenalin)
Time frame: baseline and 4 weeks of treatment
Change in catecholamine (noradrenalin)
Time frame: baseline and 4 weeks of treatment
Change in catecholamine (metabolites metanephrine)
Time frame: baseline and 4 weeks of treatment
Change in catecholamine (normetanephrine)
Time frame: baseline and 4 weeks of treatment
Change in steroid hormone
Time frame: baseline and 4 weeks of treatment
Change of ejection fraction
Time frame: baseline and 4 weeks of treatment
Change of diastolic function parameters
Time frame: baseline and 4 weeks of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (Forxiga®) and Hydrochlorothiazide 25 mg in people with Type 2 Diabetes Mellitus (T2DM), run by University Hospital Tuebingen at 1 site in Germany.
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 9 inclusion and 31 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: withdrawn, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 withdrawn before enrolling participants, so there are no results.
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?
Change in blood EPO levels (time frame: 2 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.