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Diabetes Mellitus, Type 2Phase 2REDUCE-PADNCT05912218

REducing Diabetic MacrovascUlar Complications DuE to Peripheral Arterial Disease- REDUCE-PAD

A Phase 2 study testing MEI6570 in people with Diabetes Mellitus, Type 2 and Peripheral Arterial Disease, run by National Heart Centre Singapore at 1 site in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase IIa, multi-centre study conducted at 3 sites in Singapore (SGH and NUHS, KTPH). 70 patients with diabetes mellitus (DM) and peripheral arterial disease (PAD) will be randomised in a ratio 1:1 to receive normal saline control or MEDI6570 400mg by monthly subcutaneous injection for 9 months. Read more about this study

Who is it for?
Ages 21 to 99 years
What is being tested?
MEI6570
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteSingapore
Study dates
2 Nov 2023to 1 Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 21 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomisation, and must adhere to the schedules of activities.
  • Men must be ≥ 21 years of age at the time of signing the ICF. Women must be ≥ 40 years of age at the time of signing the ICF. For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening Visit 1 by one of the following:
  • Postmenopausal, defined as amenorrhea for ≥ 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range.
  • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
  • Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.
  • Participants must have moderate stable PAD (ABI < 0.7 and/or TBI < 0.5) with no prior history of lower limb revascularisation or ulcers.
  • On stable medical therapy for type 2 DM for at least 6 weeks prior to screening with no clinically significant dose change and/or new medications in the recent 6 weeks
  • All male participants should refrain from fathering a child or donating sperm during the study and for 190 days following the last dose. Non-sterilised male study participants should be advised to use a condom for all sexual intercourse with a female partner of childbearing potential from Day 1 through the end of the study follow-up period.

Who cannot join

  • History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
  • Uncontrolled Type 1 or Type 2 diabetes defined as haemoglobin A1c (HbA1c) >10%.
  • Increased risk of bleeding
  • Patients with history or presence of any bleeding disorder.
  • Signs of ongoing bleeding at screening (e.g., identified macroscopic bleeding, low haemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator's assessment.
  • . Need for chronic therapeutic anticoagulation therapy anticipated to be required throughout the course of the study (short-term treatment with prophylactic doses of heparin/low molecular weight heparin are allowed).
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  • Known severe liver disease (e.g., ascites and/or clinical signs of coagulopathy).
  • History or presence of any of the following:
  • Cancer within 5 years before randomization, except for non-melanoma skin cancer.
  • Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.
  • Known history of hypersensitivity reactions to other biologics, to human IgG preparations, or to any component of MEDI6570, or ongoing severe allergy as judged by the investigator.
  • Patients with active positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
  • Any clinically important abnormalities in clinical chemistry, haematology, coagulation parameters, as judged by the investigator, including but not limited to:
  • AST > 2.0 × ULN.
  • ALT > 2.0 × ULN.
  • TBL > 1.5 x ULN (unless due to Gilbert's syndrome).
  • Platelet count < 100,000 platelets/μl.
  • BP values at screening Visit 1:
  • Systolic BP < 90 mmHg or > 180 mmHg.
  • Diastolic BP > 100 mmHg.
  • Participants who are excluded based on elevated BP may be rescreened following adequate treatment.
  • Any clinically important abnormalities in clinical chemistry, haematology, coagulation parameters, or urinalysis results.
  • History of blood dyscrasia, haemostatic disorder, systemic bleeding, or prior trauma that places the subject at a higher risk of bleeding.
  • Receipt of any investigational device or therapy within 6 months or 5 half-lives before screening (whichever is longer). This criterion does NOT apply for inactive, non-replicating COVID-19 vaccines approved by Health Authorities or under emergency use authorization.
  • Planned participation in an additional investigational study of an intervention or biologic before the end of the follow-up period. Participation in observational studies or studies without investigational drugs or devices is allowed.
  • Participants who are legally institutionalised.
  • An employee or close relative of an employee of the sponsor,

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Prof Derek J. Hausenloy

    Singapore, Singapore, 169609

Other trials in Singapore

About this study

This is a Phase IIa, multi-centre study conducted at 3 sites in Singapore (SGH and NUHS, KTPH). 70 patients with diabetes mellitus (DM) and peripheral arterial disease (PAD) will be randomised in a ratio 1:1 to receive normal saline control or MEDI6570 400mg by monthly subcutaneous injection for 9 months.

Read the detailed description

This is a mechanistic, randomised, double-blind, controlled Phase IIa trial that investigates whether 9 months of treatment with MEDI6570 affects lower limb microvascular perfusion and atheroma inflammation and progression. Patients with both DM and PAD will receive monthly subcutaneous injections of 400mg MEDI6570 (in an injection volume of 4.0ml), or injection/volume-matched normal saline control (4.0ml) subcutaneously, every 4 weeks for 32 weeks (9 doses in total). Com

Approximately 70 participants will be randomly assigned to a study intervention, with an anticipated 35 participants being randomized to receive active study intervention, and 35 participants being randomized to receive normal saline control.

The primary objective of the study is to determine whether monthly subcutaneous injections of MEDI6570 for 9 months reduces lower limb atheroma plaque inflammation and improves lower limb microvascular perfusion, when compared to normal saline control.

The primary endpoint in REDUCE-PAD will be the between-group difference (intervention vs. normal saline control) in the change in PET and MRI scan parameters from baseline to 9 months. Efficacy, safety, PK, and immunogenicity of MEDI6570 will also be evaluated in this study.

Being tested
MEI6570
Medical subject headings
Diabetes Mellitus, Type 2, Peripheral Arterial Disease

What participants receive

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

  • MEI6570Biological

    Also called Placebo

    Saline Control

Study groups in NCT05912218
Study groupRoleWhat they receive
MEDI6570ExperimentalBiological MEDI6570,subcutaneous injection
Receives: Biological: MEI6570
PlaceboPlacebo comparatorSaline Control,subcutaneous injection
Receives: Biological: MEI6570

What is being measured

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

  1. Lower limb atheroma plaque inflammation

    Lower limb atheroma plaque inflammation Changes from baseline to 9 months in lower limb atheroma plaque FDG uptake measured by PET/MRI scans.

    Measured: 9 months

Secondary outcomes (3)

  1. Lower limb perfusion

    Changes from baseline to 9 months in ankle brachial index (ABI) and toe brachial index (TBI)

    Measured: 9 months

  2. Lower limb microvascular perfusion

    Changes from baseline to 9 months in lower limb microvascular perfusion measured by MRI scans.

    Measured: 9 months

  3. Lower limb atheroma plaque progression

    Changes from baseline to 9 months in lower limb atheroma plaque volume measured by US arterial duplex and MRI scans

    Measured: 9 months

Timeline

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

  1. First posted22 Jun 2023
  2. Study start2 Nov 2023
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a double-blind trial that keeps all patients, study investigators blinded to the treatment. Patients who have met all inclusion criteria and none of the exclusion criteria will be assigned to one of the two study arms (MEDI6570 or normal saline control) in a 1:1 ratio. Randomization will be accomplished using a permuted block scheme with variable block size and will be stratified by study site. The trial will use randomly generated treatment allocations within sealed opaque envelopes. Reconstitution of study drug and normal saline control will be by an unblinded study team member.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05912218
Sponsor's protocol ID
REDUCE-PAD 1
Acronym
REDUCE-PAD
Status last verified
Nov 2024
First submitted
16 May 2023
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MEI6570 in people with Diabetes Mellitus, Type 2 and Peripheral Arterial Disease, run by National Heart Centre Singapore at 1 site in Singapore.

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 8 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. 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 Singapore. 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 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?

This study is still under way. Results are not available in the source record yet.

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?

Lower limb atheroma plaque inflammation (time frame: 9 months). 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 NCT05912218.

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 21 Nov 2024.

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