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

NCT05912218 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: REDUCE-PAD 1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (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.

  9 months

Secondary Outcomes (3)

• Lower limb perfusion

  9 months

• Lower limb microvascular perfusion

  9 months

• Lower limb atheroma plaque progression

  9 months

Study Arms (2)

MEDI6570

EXPERIMENTAL

Biological MEDI6570,subcutaneous injection

Biological: MEI6570

Placebo

PLACEBO COMPARATOR

Saline Control,subcutaneous injection

Biological: MEI6570

Interventions

MEI6570 BIOLOGICAL

Saline Control

Also known as: Placebo

MEDI6570; Placebo

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• Singapore General Hospital: collaborator
• Khoo Teck Puat Hospital: collaborator
• National University Health System, Singapore: collaborator

Study Sites (1)

Prof Derek J. Hausenloy

Singapore, Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 22, 2023
• Study Start: November 2, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

SG (1)