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Diabetic FootPhase 2NCT03128320

The Effects of BAY1193397 on Skin Capillary Blood Flow and Transcutaneous Oxygen Pressure

A Phase 2 study testing BAY1193397 in people with Diabetic Foot, run by Bayer at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to analyse skin blood flow in diabetic patients. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397. The analysis of safety and tolerability are secondary objectives of this study. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Diabetic Foot
What is being tested?
BAY1193397
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteUnited Kingdom
Study dates
25 May 2017to 28 Oct 2019
Phase
Phase 2
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 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The informed consent must be signed before any study specific tests or procedures are done (patient must be able to give informed consent, no legal representative allowed)
  • Patients with a diagnosis of type II diabetes mellitus and PAD (peripheral artery disease) and/or microangiopathy as evidenced by at least one of the following criteria:
  • TBPI (toe / brachial blood pressure index) < 0.7 at screening
  • ischemic or neuro-ischemic DFU (diabetic food ulcer) in medical history (verified by medical records)
  • clinical diagnosis of PAD in medical history (verified by medical records)
  • diagnosis of nephropathy that is most likely due to diabetes mellitus type II
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  • diagnosis of diabetic retinopathy
  • diagnosis of diabetic polyneuropathy
  • Age 55 to 75 years (inclusive) at the screening visit
  • Non-smokers are preferred for inclusion in this study. If smokers are included, they must refrain from smoking on the days of treatment periods 1, 2, and 3 until all examinations have been performed
  • Patients are expected to be on stable medication during study conduct. No planned changes in drug therapy during active treatment period of the study (i.e. from treatment period 1 to treatment period 3) is allowed.
  • Men or confirmed postmenopausal women (defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone [FSH] levels > 40 mIU/mL) or women without childbearing potential based on surgical treatment 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification). Male patients, who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for 12 weeks after receiving the investigational medicinal product and not to act as sperm donor for 12 weeks after dosing. Acceptable methods of contraception include for example: a) condoms (male or female) with or without a spermicidal agent b) diaphragm or cervical cap with spermicide c) intrauterine device d) hormone-based contraception
  • Ability to understand and follow study related instructions

Who cannot join

  • Patients with existing lower limb ulcers
  • Patients with nailfold capillaries at the great toe that are technically difficult to assess
  • Patients suffering from PAD Fontaine Stage 4
  • Patients requiring planned revascularization
  • Patients suffering from diseases other than diabetes mellitus that are known to lead to disturbances in skin microcirculation or interfering with the method of measurement such as Raynaud's disease, collagen vascular disorders , atopic dermatitis, psoriasis
  • Myocardial infarction, acute coronary syndrome, transient ischemic attack (TIA), stroke, revascularization, angioplasty within 3 months prior to randomization
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  • Any planned surgical intervention during the course of the study
  • Medical condition or history thereof or any deviation from normal laboratory values that in the opinion of the investigator would impair the ability to complete the planned study procedures.
  • Any surgical or medical condition which significantly alters absorption, distribution, metabolism or excretion of study drugs, including, but not limited to: history of major gastrointestinal (GI) tract surgery, inflammatory bowel disease, currently active gastritis, pancreatitis, treatment with cholestyramine and colestipol resins
  • Patients with HbA1c > 12% (> 108 mmol/mol) at the screening visit
  • Any other condition or therapy, which would make the subject unsuitable for this study and will not allow participation for the full planned study period (e.g. active malignancy or other condition limiting life expectancy to less than 12 months)
  • Use of alpha- or beta-AR (adrenoreceptor) agonists
  • Use of alpha-AR antagonists
  • Use of serotonin/norepinephrine reuptake inhibitors (SNRIs)
  • Use of tricyclic antidepressants at a dose equivalent of more than 50 mg amitryptyline
  • No pedicure or nail polish is allowed from screening until the end of the active study period (end of treatment period 3)
  • Systolic blood pressure below 100 mmHg or above 180 mmHg at the screening visit based on the average of three readings taken from the arm with the highest systolic recordings
  • Diastolic blood pressure below 50 or above 110 mmHg at the screening visit based on the average of three readings taken from the arm with the highest systolic recordings
  • Heart rate below 50 or above 100 beats/min at screening (obtained from ECG)
  • Clinically relevant findings in the physical examination which, in the opinion of the investigator, preclude participation for reasons of the patient's safety
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) formula at screening

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Royal Devon & Exeter Hospital

    Exeter, Devon, EX2 5AX

Other trials in United Kingdom

About this study

Official title: A Randomized, Single-blind, Threefold Crossover, Single-center Study to Assess the Safety and the Effects of 1 mg and 5 mg BAY1193397 in Comparison to Placebo on Skin Capillary Blood Flow and Transcutaneous Oxygen Pressure After Single Dose in Type II Diabetic Patients

The purpose of the study is to analyse skin blood flow in diabetic patients. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397. The analysis of safety and tolerability are secondary objectives of this study.

Conditions
Diabetic Foot
Being tested
BAY1193397, Placebo
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1193397Drug

    Single dose of 1 mg BAY1193397 given in the fasted state

  • BAY1193397Drug

    Single dose of 5 mg BAY1193397 given in the fasted state

  • PlaceboDrug

    Single dose of placebo given in the fasted state

Study groups in NCT03128320
Study groupRoleWhat they receive
BAY1193397/Placebo (sequence A-B-C)ExperimentalSubjects with type II diabetes who follow treatment sequence A-B-C. Single oral dose of a placebo tablet in the first intervention period (Treatment A); followed by single oral dose of 1 mg BAY1193397 (Treatment B); then single oral dose of 5 mg BAY1193397 IR tablet under fasted state in the third intervention period (Treatment C). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment.
Receives: Drug: BAY1193397; Drug: Placebo
BAY1193397/Placebo (sequence B-C-A)ExperimentalSubjects with type II diabetes who follow treatment sequence B-C-A. Single oral dose of 1 mg BAY1193397 in the first intervention period (Treatment B); followed by single oral dose of 5 mg BAY1193397 IR tablet under fasted state in the second intervention period (Treatment C), then single oral dose of a placebo tablet under fasted conditions in the third intervention period (Treatment A). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment.
Receives: Drug: BAY1193397; Drug: Placebo
BAY1193397/Placebo (sequence B-A-C)ExperimentalSubjects with type II diabetes who follow treatment sequence B-A-C. Single oral dose of 1 mg BAY1193397 in the first intervention period (Treatment B); followed by single oral dose of a placebo tablet in the second intervention period (Treatment A), then 5 mg BAY1193397 IR tablet under fasted conditions in the third intervention period (Treatment C). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment.
Receives: Drug: BAY1193397; Drug: Placebo

What is being measured

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

  1. Change in resting capillary blood flow velocity (CBV)

    = resting CBV after study drug administration - resting CBV before study drug administration

    Measured: Before and after treatment with study drug (within 1-3 hours after treatment with study drug)

  2. Change in peak CBV during reactive hyperemia

    = peak CBV after study drug administration - peak CBV before study drug administration

    Measured: Before and after treatment with study drug (within 1-3 hours after treatment with study drug)

  3. Change in time to peak CBV during reactive hyperemia

    = time to peak CBV after study drug administration - time to peak CBV before study drug administration

    Measured: Before and after treatment with study drug (within 1-3 hours after treatment with study drug)

  4. Change in transcutaneous oxygen pressure (TcPO2)

    = TcPO2 after study drug administration - TcPO2 before study drug administration

    Measured: Before and after treatment with study drug (within 1-3 hours after treatment with study drug)

Secondary outcomes (2)

  1. Number of subjects with treatment-emergent adverse events (TEAEs)

    Measured: From first application of study medication up to 2 days after end of treatment with study medication

  2. Number of subjects with TEAEs in different severity

    Measured: From first application of study medication up to 2 days after end of treatment with study medication

Timeline

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

  1. First posted25 Apr 2017
  2. Study start25 May 2017
  3. Primary completion6 Sep 2019
  4. Study completion28 Oct 2019

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03128320
Sponsor's protocol ID
17500
Other IDs
2015-003799-63, 2015
Status last verified
Aug 2020
First submitted
21 Apr 2017
Last updated
13 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY1193397 in people with Diabetic Foot, run by Bayer at 1 site in United Kingdom.

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 13 inclusion and 21 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 13 Aug 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 United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in resting capillary blood flow velocity (CBV) (time frame: Before and after treatment with study drug (within 1-3 hours after treatment with study drug)). The study lists 4 primary outcomes in all. 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 NCT03128320.

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 13 Aug 2020.

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