300 Participants NeededMy employer runs this trial

HP-211 for Type 2 Diabetes

Recruiting at 24 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?

Blood sugar levels are controlled by insulin, a hormone made by cells in the pancreas. After a meal, carbohydrates are broken down into glucose which is absorbed from the intestine into the blood leading to a rise in glucose (blood sugar) which triggers the secretion of insulin. Insulin binds to cells in several tissues including liver, muscle, and fat, triggering cells to take up glucose and bring the blood glucose level back to normal.

A high blood sugar level is known as diabetes. The most common form of diabetes, type 2 diabetes, is caused by insulin resistance; that is, a reduced ability of insulin to stimulate glucose uptake into cells. The body compensates for insulin resistance by making more insulin; type 2 diabetes occurs when the pancreas can no longer make enough insulin to control blood glucose. The high blood glucose and insulin levels lead to long-term complications such as heart attacks, kidney failure, reduced sensation and poor circulation in the feet and legs. High insulin levels also increase the incidence of cancers, stroke, and dementia.

Reducing blood glucose levels with oral medications and insulin reduces risk of diabetic complications. There are several types of oral medications available for treating diabetes; however, they do not always control blood glucose adequately. In addition, these drugs have complications and are not used to treat insulin resistance and prediabetes - a condition when blood glucose is higher than normal but not high enough to be classified as diabetes. Prediabetes often progresses to diabetes over a period of months or years. Effective and safe treatments for insulin resistance may prevent the onset of diabetes or even reverse diabetes if diagnosed in its early stages before substantial damage to the pancreas has occurred.

HP-211 is a botanical extract whose active ingredients are derived from herbs and vegetables present in normal diets. HP-211 has been shown in laboratory studies in cell culture, in animal studies, and in a previous Phase 1 study to enhance the ability of insulin to stimulate glucose uptake into cells. Thus, HP-211 may reduce the blood glucose and circulating insulin levels of subjects with type 2 diabetes after a meal. HP-211 may also reduce glucose and insulin responses to a greater extent in insulin-resistant as compared to insulin-sensitive subjects.

Subjects will take 0, 1, 2 or 3 tablets of HP-211 in the morning and evening for 90 days. Hemoglobin A1c (HbA1c, or "A1c"), a measure of the average amount of glucose present in the blood, will be measured during the trial period.

Are You a Good Fit for This Trial?

Inclusion Criteria

I meet a main requirement for the study.
I have been on the same metformin dose or only diet and exercise for at least 3 months.
I have had type 2 diabetes for more than 3 months but less than 5 years.
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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

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+