Type 2 Diabetes MellitusPhase 4NCT03254849
Empagliflozin and Sympathetic Nerve Traffic
A Phase 4 study testing Empagliflozin and Hydrochlorothiazide 25 mg in people with Type 2 Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the kidney with empagliflozin compared to hydrochlorothiazide on blood pressure and on central sympathic nervous activity will be examined. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Empagliflozin and Hydrochlorothiazide 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 8 Dec 2017to 20 Apr 2020
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women and men >= 50 and <= 80 years of age
- type 2 diabetes mellitus for >=2 years
- only metformin monotherapy is allowed; metformin dose must have been stable for >=12 weeks
Who cannot join
- previous empagliflozin treatment within the last 3 months
- heart failure NYHA II - IV
- subjects who have received any investigational medicinal product or have used any investigational medical device within 30 days prior to the screening visit, or who are actively participating in any investigational medicinal product or medical device trial, or who are scheduled for any such trial during the course of the trial.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460
About this study
Official title: Effects on Blood Pressure and Central Sympathetic Nerve Traffic by SGLT2-inhibition With Empagliflozin Compared to Hydrochlorothiazide in Patients With Type 2 Diabetes Mellitus
In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the kidney with empagliflozin compared to hydrochlorothiazide on blood pressure and on central sympathic nervous activity will be examined.
Read the detailed description
The drug empagliflozin is a selective oral inhibitor of the sodium-glucose co-transporter 2 (SGLT-2) in the kidney.On the market empagliflozin is approved for the treatment of type 2 Diabetes. The mechanism of action can be described as follows: SGLT-2 is responsible for 90% of the reabsorption of Glucose in the kidney. If this Transport System is inhibited the secretion of glucose via the urine is increased. Therefore the blood glucose concentration will be lowered.
It has been noted that the SGLT-2 drugs are lowering the blood pressure as well, but the specific characteristics of the durg leading to this effect have not been examined in adequate clinical trial up to now.
To evaluate the central sympathic nervous activity a microneurography will be performed in this study; this examination will provide Information if empagliflozin dose decrease the sympathic nervous activity. If this is the case new effects of empagliflozin have to be discussed, Otherwise it can be assumed that the blood pressure decrease is a result of an increase of urine volume. In this case the sympathic activity should be increased.
This study will be performed in parallel groups who will receive a double-blind, randomised treatment, either empagliflozin or hydrochlorothiazide. The hypothesis that empagliflozin - in contrast to hydrochlorthiazide - does not increase the sympathic nervous activity in obese, hypertensive subjects with type 2 Diabetes treated with metformin will be tested.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Empagliflozin, Hydrochlorothiazide 25 mg
- 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.
EmpagliflozinDrug
Also called Jardiance
1 tablet
Hydrochlorothiazide 25 mgDrug
Also called HCT
1 tablet
| Study group | Role | What they receive |
|---|---|---|
| empagliflozin 25 mg | Experimental | Each patient will take 2 tablets each day to ensure double-blind Treatment. Arm 1: 25 mg/d empagliflozin + hydrochlorothiazide placebo Receives: Drug: Empagliflozin |
| hydrochlorothiazide 25 mg | Experimental | Each patient will take 2 tablets each day to ensure double-blind Treatment. Arm 2: 25 mg/d hydrochlorothiazide + empagliflozin placebo Receives: Drug: Hydrochlorothiazide 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure reduction
Blood pressure reduction with empagliflozin treatment is associated with lesser increase in sympathetic nerve traffic when compared to Hydrochlorothiazide treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start8 Dec 2017
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Heise, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254849
- Sponsor's protocol ID
- 00/0764-Empa2
- Status last verified
- Jul 2020
- First submitted
- 14 Aug 2017
- Last updated
- 14 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Blood Pressure and Central Sympathetic Nerve Traffic by SGLT2-inhibition With Empagliflozin Compared to Hydrochlorothiazide in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03254849
- Acronym / sponsor ID
- 00/0764-Empa2
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 21 Aug 2017 (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.
In this study the effects of the Inhibition of the Sodium-Glucose Linked Transporter 2 in the kidney with empagliflozin compared to hydrochlorothiazide on blood pressure and on central sympathic nervous activity will be examined.
Detailed description
The drug empagliflozin is a selective oral inhibitor of the sodium-glucose co-transporter 2 (SGLT-2) in the kidney.On the market empagliflozin is approved for the treatment of type 2 Diabetes. The mechanism of action can be described as follows: SGLT-2 is responsible for 90% of the reabsorption of Glucose in the kidney. If this Transport System is inhibited the secretion of glucose via the urine is increased. Therefore the blood glucose concentration will be lowered.
It has been noted that the SGLT-2 drugs are lowering the blood pressure as well, but the specific characteristics of the durg leading to this effect have not been examined in adequate clinical trial up to now.
To evaluate the central sympathic nervous activity a microneurography will be performed in this study; this examination will provide Information if empagliflozin dose decrease the sympathic nervous activity. If this is the case new effects of empagliflozin have to be discussed, Otherwise it can be assumed that the blood pressure decrease is a result of an increase of urine volume. In this case the sympathic activity should be increased.
This study will be performed in parallel groups who will receive a double-blind, randomised treatment, either empagliflozin or hydrochlorothiazide. The hypothesis that empagliflozin - in contrast to hydrochlorthiazide - does not increase the sympathic nervous activity in obese, hypertensive subjects with type 2 Diabetes treated with metformin will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empagliflozin 25 mg | Experimental | Drug: EmpagliflozinEach patient will take 2 tablets each day to ensure double-blind Treatment. Arm 1: 25 mg/d empagliflozin + hydrochlorothiazide placebo |
| hydrochlorothiazide 25 mg | Experimental | Drug: Hydrochlorothiazide 25 mgEach patient will take 2 tablets each day to ensure double-blind Treatment. Arm 2: 25 mg/d hydrochlorothiazide + empagliflozin placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women and men >= 50 and <= 80 years of age
- type 2 diabetes mellitus for >=2 years
- only metformin monotherapy is allowed; metformin dose must have been stable for >=12 weeks
Key exclusion criteria (3 listed)
- previous empagliflozin treatment within the last 3 months
- heart failure NYHA II - IV
- subjects who have received any investigational medicinal product or have used any investigational medical device within 30 days prior to the screening visit, or who are actively participating in any investigational medicinal product or medical device trial, or who are scheduled for any such trial during the course of the trial.
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 |
|---|---|---|
| EmpagliflozinAlso: Jardiance1 tablet | Drug | empagliflozin 25 mg |
| Hydrochlorothiazide 25 mgAlso: HCT1 tablet | Drug | hydrochlorothiazide 25 mg |
Primary outcome
Blood Pressure reduction
Time frame: 6 weeks
Blood pressure reduction with empagliflozin treatment is associated with lesser increase in sympathetic nerve traffic when compared to Hydrochlorothiazide treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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.
Tim Heise, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
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 Empagliflozin and Hydrochlorothiazide 25 mg in people with Type 2 Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jul 2020. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood Pressure reduction (time frame: 6 weeks). 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 14 Jul 2020.