A Phase 4 interventional study of Empagliflozin and Hydrochlorothiazide 25 mg in Type 2 Diabetes Mellitus, sponsored by Profil Institut für Stoffwechselforschung GmbH. Completed at 1 site in Germany. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Profil Institut für Stoffwechselforschung GmbH · Phase 4, Interventional, and Treatment
Among 130 studies testing empagliflozin in Diabetes Mellitus, Type 2 — 18 open to participants now, 19 under way, 1 of them phase 3. empagliflozin · Diabetes Mellitus, Type 2.
Among the 130 studies testing empagliflozin in Diabetes Mellitus, Type 2, this one is the 68th largest by enrollment, is one of 14 that started in 2017, is one of 50 in phase 4, and was the 57th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 75 is close to the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →18 of the 130 studies testing empagliflozin in Diabetes Mellitus, Type 2 are open now, in 10 countries. Each count lists the studies.
empagliflozin: first FDA approval 2014 (JARDIANCE), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 50 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →130 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 14 started in 2017.
Median enrollment 79 across the 130 interventional studies. Of the 91 that completed or were terminated, 38 (42%) have results posted.
62 of 130 have an industry lead sponsor. The 10 most frequent:
Profil Institut für Stoffwechselforschung GmbH is the lead sponsor of 26 studies on the registry; 1 is open to participants now.
Profil Institut für Stoffwechselforschung GmbH has 9 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
10 of the studies testing empagliflozin in Diabetes Mellitus, Type 2 that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07093476Phase 3CelltrionEfficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin | 2026-12 |
| NCT05164263Getz PharmaReal World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study | 2026-12-31 |
| NCT06989723Seoul National University Bundang HospitalPioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes | 2026-12-31 |
| NCT07442006JW PharmaceuticalGlycemic Variability of Combination Therapies in T2DM | 2027-03-31 |
| NCT05960656The University of Texas Health Science Center at San AntonioSGLTi, Hepatic Glucose Production and Ketogenesis | 2027-06-01 |
Among the 130 studies testing empagliflozin in Diabetes Mellitus, Type 2, from their registry updates:
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.
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.
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.
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 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.
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.
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.
Each patient will take 2 tablets each day to ensure double-blind Treatment. Arm 1: 25 mg/d empagliflozin + hydrochlorothiazide placebo
Drug: Empagliflozin
Each patient will take 2 tablets each day to ensure double-blind Treatment. Arm 2: 25 mg/d hydrochlorothiazide + empagliflozin placebo
Drug: Hydrochlorothiazide 25 mg
1 tablet
Also known as: Jardiance
1 tablet
Also known as: HCT
Blood Pressure reduction
Blood pressure reduction with empagliflozin treatment is associated with lesser increase in sympathetic nerve traffic when compared to Hydrochlorothiazide treatment
Time frame: 6 weeks
Ran from Dec 2017 to primary completion in Apr 2020, 28 months.
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 28 months is above 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 Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Empagliflozin · Hydrochlorothiazide
Profil Institut für Stoffwechselforschung GmbH →