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Diabetes Mellitus, Type IIPhase 4NCT02985242

Empagliflozin Reduces Progression of Diabetic Retinopathy in Patients With High Risk of Diabetic Macular Edema

A Phase 4 study testing Empagliflozin and Glimepiride in people with Diabetes Mellitus, Type II, run by Hannover Medical School at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, randomized, active control, two-arm parallel, double-blind, monocenter phase IV clinical trial. The trial compares empagliflozin to glimepiride in patients with type 2 diabetes mellitus in addition to standard of care treatment. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type II
What is being tested?
Empagliflozin and Glimepiride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
1 siteGermany
Study dates
12 Jun 2017to 16 Aug 2018
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • women and men between 18 - 80 years of age
  • type 2 diabetes mellitus
  • early to moderate stage diabetic retinopathy (ETDRS: 20 (microaneurysms only) to 35 (microaneurysms/ hemorrhages and/or hard exsudates)) in one or both eyes
  • stable HbA1c (± 0.5%) for at least 12 weeks
  • antidiabetic treatment with either diet, metformin, DPP4, GLP1, pioglitazone, acarbose, or respective combinations
  • HbA1c ≥ 6.5 and ≤ 10.0 %
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  • body mass index < 46 kg/m2
  • office blood pressure ≤ 150/95 mmHg (confirmed on a second day; 24h ambulatory blood pressure measurement (ABPM) is allowed to check accuracy of office values; inclusion with 24h mean blood pressure ≤ 145/90 mm Hg is possible); patients with hypertension should be treated according to current treatment guidelines
  • either women without childbearing potential defined by:
  • at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy
  • hysterectomy
  • ≥ 50 years and in postmenopausal state > 1 year
  • < 50 years and in postmenopausal state > 1 year with serum follicle stimulating hormone (FSH) > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening or women of childbearing potential with a negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of 4 days following the last administration of study medication:
  • correct use of one of the following accepted contraception methods: hormonal contraceptives (combined oral contraceptives, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUD/IUS) or a double barrier method, e.g. condom and occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
  • true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
  • sexual relationship only with female partners
  • sterile male partners
  • signed written informed consent and willingness to comply with treatment and follow-up procedures
  • capability of understanding the investigational nature, potential risks and benefits of the clinical trial

Who cannot join

  • Type 1 diabetes
  • uncontrolled diabetes mellitus type 2 with fasting glucose > 13.3 mmol/l confirmed on a second day
  • known or suspected hypersensitivity to empagliflozin, glimepiride, or any excipients; and / or known or suspected hypersensitivity to sulfonylureas, sulfonamides or SGLT2 inhibitors in general
  • history of multiple severe hypoglycemic episodes within the last two years
  • use of Insulin, SGLT2-inhibitor, sulfonylurea derivate or a glinide within past 3 months
  • clinical significant macular edema in both eyes and indication for intravitreal anti-VEGF treatment for both eyes at screening or baseline visit. Eyes with a small amount of intraretinal or subretinal fluid (seen in OCT) but no need for intravitreal treatment as judged by the investigator (according to current practice patterns) may be included. Eyes with a history of intravitreal treatment of macular edema which do not need ongoing intravitreal treatment at the time of screening may be included.
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  • eye diseases or pathologies that prevent clear ophthalmoscopy and evaluation of study parameters, thus not allowing study participation according to the investigator´s judgment, such as (but not only) vitreous hemorrhage, mature cataract, macular pathologies other than diabetic maculopathy
  • history of ketoacidosis or metabolic acidosis
  • use of loop diuretics
  • history of > 1 urogenital infection/year
  • any history of stroke, transient ischemic attack (TIA), instable angina pectoris or myocardial infarction within last 3 months prior to baseline visit
  • congestive heart failure New York Heart Association (NYHA) III and IV
  • severe valvular or left ventricular outflow obstruction disease needing intervention;
  • atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute
  • chronic lower urinary tract infections (but not simple asymptomatic bacteriuria)
  • eGFR < 60 ml/min/1,73 m2 (MDRD-formula, confirmed on a second day)
  • chronic diarrhea, any clinical signs of volume depletion or a hematocrit > 48 % (women) and > 53 % (men)
  • elevated risk for volume depletion, e.g. history of severe volume depletion that required medical therapy
  • chronic liver disease (including known active hepatitis) and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) > 3 x upper limit of normal (ULN) (confirmed on a second day)
  • Subjects with known seropositivity to human immunodeficiency virus.
  • acute illness at screening or randomization according to judgement by the investigator or patient
  • drug or alcohol abuse
  • psychosomatic or psychiatric diseases requiring hospitalization during the last 12 months
  • clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia (5 years prior to randomization)
  • any medical or surgical intervention planned for the next 13 months after randomization not allowing study participation according to the investigator´s judgment
  • current participation in any other clinical trial or participation in another clinical trial within 30 days before screening

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Hannover Medical School, University Eye Hospital and CRC Core Facility Hannover

    Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

Official title: SGLT2-inhibition With Empagliflozin Reduces Progression of Diabetic Retinopathy in Patients With High Risk of Diabetic Macular Edema (The SUPER-Trial)

This is a prospective, randomized, active control, two-arm parallel, double-blind, monocenter phase IV clinical trial. The trial compares empagliflozin to glimepiride in patients with type 2 diabetes mellitus in addition to standard of care treatment.

Patients with type 2 diabetes mellitus who are between 18 and 80 years of age will be recruited for the clinical trial and randomly allocated to either receive empagliflozin or glimepiride.

The assumption of the study is that empagliflozin slows down diabetic retinopathy progression rate and thus a lower microaneurysm formation rate compared to subjects treated with glimepiride by substantially decreased cellular glucotoxicity will be achieved.

Being tested
Empagliflozin, Glimepiride, Empagliflozin placebo, Glimepiride placebo
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

    Empagliflozin film-coated tablet

  • GlimepirideDrug

    Glimepiride tablet

  • Empagliflozin placeboDrug

    Placebo tablet manufactured to mimic Empagliflozin 25 mg film-coated tablet

  • Glimepiride placeboDrug

    Placebo tablet manufactured to mimic Glimepiride 2 mg tablet

Study groups in NCT02985242
Study groupRoleWhat they receive
Empagliflozin/glimepiride placeboExperimentalEmpagliflozin 25 mg film-coated tablet p.o. daily and glimepiride matching placebo p.o. daily Duration of treatment: 12 months
Receives: Drug: Empagliflozin; Drug: Glimepiride placebo
Glimepiride/empagliflozin placeboActive comparatorGlimepiride 2 mg tablet p.o. daily and empagliflozin matching placebo p.o. daily Duration of treatment: 12 months
Receives: Drug: Glimepiride; Drug: Empagliflozin placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microaneurysm formation rate over 12 months, i.e. number of newly developed microaneurysms within 12 months

    Measured: Weeks 27 and 52

Secondary outcomes (13)

  1. Change in diabetic retinopathy stage (≥ 2 step change on ETDRS severity score)

    Measured: Weeks 27 and 52

  2. Change in microaneurysm count

    Measured: Weeks 27 and 52

  3. Microaneurysm formation rate after 6 months (compared to baseline)

    Measured: after 6 months

  4. Change in retinal thickness (as measured by Optical Coherence Tomography)

    Measured: Weeks 27 and 52

  5. Change in retinal perfusion of microvasculature within the retina (flow in Optical Coherence Tomography Angiography)

    Measured: Weeks 27 and 52

  6. Progression to clinically significant macular edema (CSME)

    Measured: Up to 52 weeks

  7. Change in intraocular lipid content (hard exsudates)

    Measured: Weeks 27 and 52

  8. Change in composite clinical outcome evaluating progression to proliferative diabetic retinopathy (PDR) based on photography, angiography plus clinically important events defining PDR (e.g. vitreous haemorrhage)

    Measured: Weeks 27 and 52

  9. Change in best corrected visual acuity (BCVA [ETDRS letters])

    Measured: Weeks 27 and 52

  10. Change in HbA1c

    Measured: Weeks 2, 7, 12, 17, 22, 27, 32, 37, 42, 47, 52 and 55

  11. Change in fasting glucose

    Measured: Weeks 2, 7, 12, 17, 22, 27, 32, 37, 42, 47, 52 and 55

  12. Change in body weight and body fat mass

    Measured: Weeks 27, 52 and 55

  13. Change in ambulatory blood pressure

    Measured: Weeks 27 and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2016 (estimated)
  2. Study start12 Jun 2017
  3. Primary completion1 Aug 2018
  4. Study completion16 Aug 2018

Why it stopped: difficulties to recruit planned numbers of patients within reasonable time frame

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985242
Sponsor's protocol ID
M16-04EMPA-EYE
Other IDs
2016-000825-38, 2016
Status last verified
Sep 2018
First submitted
25 Nov 2016
Last updated
27 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin and Glimepiride in people with Diabetes Mellitus, Type II, run by Hannover Medical School 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 19 inclusion and 26 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: stopped early, as of the sponsor's last update on 27 Sep 2018. 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 was stopped early (reason given: difficulties to recruit planned numbers of patients within reasonable time frame). Results are not available in the source record.

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?

Microaneurysm formation rate over 12 months, i.e. number of newly developed microaneurysms within 12 months (time frame: Weeks 27 and 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02985242.

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 27 Sep 2018.

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