REducing Diabetic MacrovascUlar Complications DuE to Peripheral Arterial Disease- REDUCE-PAD (NCT05912218) | Clinical Trial Compass
Active — Not RecruitingPhase 2
REducing Diabetic MacrovascUlar Complications DuE to Peripheral Arterial Disease- REDUCE-PAD
Singapore70 participantsStarted 2023-11-02
Plain-language 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.
Who can participate
Age range
21 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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).