300 Participants NeededMy employer runs this trial

HP-211 for Type 2 Diabetes

Recruiting at 3 trial locations
HS
Overseen ByHousey Study Info
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Housey Healthcare ULC
Must be taking: Metformin
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HP-211, a natural extract from herbs and vegetables. HP-211 aims to assist people with type 2 diabetes by enhancing insulin's ability to lower blood sugar levels after meals. The study will compare different doses of HP-211 to evaluate its effectiveness and safety. Participants should have had type 2 diabetes for more than three months but less than five years and be managing their condition with metformin or through diet and exercise. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are currently taking metformin, you can continue with it as long as your dose has been stable for at least 3 months. However, if you are on any other diabetes medications, you must have stopped them at least 3 months before joining the trial.

Is there any evidence suggesting that HP-211 is likely to be safe for humans?

An earlier study demonstrated that HP-211 helped tissues absorb more glucose and reduced both blood sugar and fat levels in animals. This suggests it might also help control blood sugar in people. Importantly, a previous Phase 1 study with humans showed that HP-211 was generally safe, with most participants not experiencing serious side effects. The treatment is made from herbs and vegetables commonly found in diets, which might enhance its safety. While this trial will provide more information, these early results are promising for safety.12345

Why do researchers think this study treatment might be promising?

HP-211 is unique because it may offer a new approach for managing Type 2 Diabetes, as it is being tested in multiple doses to find the most effective option. Unlike many standard treatments like metformin or insulin, which primarily focus on controlling blood sugar levels, HP-211 could have a different mechanism of action that researchers are keen to explore. This new treatment might provide an alternative for patients who struggle with current medications, potentially offering improved efficacy or fewer side effects.

What evidence suggests that HP-211 might be an effective treatment for type 2 diabetes?

Research has shown that HP-211 can enhance insulin's effectiveness, enabling cells to absorb more sugar from the blood and thereby lower blood sugar levels. Studies in labs and with animals have found that it aids the body in absorbing more sugar and reduces both blood sugar and triglycerides, a type of fat in the blood. A previous study suggested that HP-211 could lower blood sugar and insulin levels after meals in people with type 2 diabetes. This trial will test different dose levels of HP-211 to evaluate its effectiveness in managing blood sugar levels by improving insulin utilization, particularly for those with insulin resistance.23467

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes diagnosed within the last 5 years, who have been on a stable dose of metformin or just diet and exercise for at least 3 months. Their average blood sugar (HbA1c) must be between 6.5% and 10%.

Exclusion Criteria

Were you diagnosed with Diabetes over 5 years ago?
Have you ever used insulin or GLP-1s (like semaglutide)?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take 0, 1, 2, or 3 tablets of HP-211 in the morning and evening for 90 days

12 weeks
Regular visits for monitoring and assessments

Withdrawal

Participants undergo a withdrawal phase to assess changes post-treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • HP-211

Trial Overview

The study tests HP-211, a plant-based supplement, versus placebo in people with type 2 diabetes. Participants take up to three tablets twice daily for 90 days to see if HP-211 helps lower blood sugar levels.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: HP-211 Dose Level 3Experimental Treatment1 Intervention
Group II: HP-211 Dose Level 2Experimental Treatment2 Interventions
Group III: HP-211 Dose Level 1Experimental Treatment2 Interventions
Group IV: HP-211 Dose Level 4Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Housey Healthcare ULC

Lead Sponsor

Trials
1
Recruited
20+

Citations

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