HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes

April 20, 2026 updated by: Housey Healthcare ULC

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After consumption of a meal, pancreatic secretions of various digestive enzymes result in the breakdown of carbohydrates into monosaccharides such as glucose. These sugars are subsequently absorbed through the intestinal lumen, resulting in an increased plasma glucose concentration. In response to high glucose levels, pancreatic beta cells are stimulated to release insulin, a hormone which circulates through the bloodstream and binds to insulin-responsive cells including adipocytes (fat tissue), myocytes (muscle), hepatocytes (liver), and neurons in various regions of the brain. The resulting insulin-mediated signaling cascade initiates intracellular glucose uptake within peripheral tissues leading to a corresponding decrease in circulating plasma glucose.

In insulin responsive cells the stimulation of glucose uptake begins after the binding of insulin to Insulin Receptors (IR). These receptors are found on the membrane surface of cells in insulin-responsive tissues. The IR consists of an extracellular domain which binds to insulin, and an intracellular domain that has a protein tyrosine kinase activity. The binding of Insulin to the IR initiates a series of autophosphorylation events within the protein kinase domain that permit interaction and phosphorylation of downstream signaling proteins in the cell that mediate the cellular response to insulin. The resulting signaling complex includes proteins in the Insulin Receptor Substrate (IRS) family known as IRS-1 and IRS-2. These key targets of the insulin signaling pathway link IR activation to downstream signaling cascades that mediate intracellular processes including GLUT4-mediated glucose uptake.

Prediabetes and Type II diabetes involve an impaired post-receptor response to insulin that hinders the glucose uptake response after meal consumption. Chronic hyperglycemia and the resulting compensatory hyperinsulinemia promote a cohort of acute and chronic sequelae including cardiovascular disease, liver complications, central nervous system degeneration, abnormal cellular growth resulting in an increased incidence of several forms of cancer, and hyperglycemic osmotic stress.

HP-211 is a botanical extract containing active ingredients derived from edible plant species herbs and vegetables present in normal diets.In vitro, HP-211, has marked effects on the IRS-2 branch of the insulin signaling cascade to enhance downstream insulin signaling. HP-211 has been shown in animal models to increase glucose uptake in peripheral tissues and decrease circulating blood glucose and triglyceride concentrations. Regular supplementation of the diet with HP-211 may reduce the incidence of associated prediabetic and diabetic complications, resulting in an increased quality of life for patients without resorting to current anti-diabetic prescription drugs that may have undesirable side effects.

Hypotheses HP-211 will reduce postprandial glucose and insulin levels in subjects with new onset type 2 diabetes as well as subjects with existing type 2 diabetes who are not well-controlled despite using the maximum tolerated dose of metformin. The reduction in glucose and insulin will be relatively greater in insulin-resistant than insulin-sensitive subjects. Over a 90-day treatment period, these effects will lead to a reduction in hemoglobin A1c (HbA1c), a measure of long-term blood glucose control.

Subjects will take 0, 1, 2, or 3 tablets of HP-211 in the morning and evening, preferably at least 60 minutes before a meal. Hemoglobin A1c and numerous additional measures of glucose control as well as safety studies will be determined.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Canoga Park, California, United States, 91303
    • Florida
      • Doral, Florida, United States, 33166
        • Recruiting
        • Universal Axon Clinical Research
        • Contact:
        • Principal Investigator:
          • Luis Martinez, MD
      • Edgewater, Florida, United States, 32132
        • Recruiting
        • Velocity Clinical Research New Smyrna Beach
        • Principal Investigator:
          • Margaret Chang, MD
        • Contact:
      • Fort Myers, Florida, United States, 33907
        • Recruiting
        • Southwest General Healthcare Center
        • Principal Investigator:
          • Jose Rodriguez, MD
        • Contact:
      • Miami, Florida, United States, 33155
      • Miami, Florida, United States, 33176
        • Recruiting
        • IMIC Research
        • Principal Investigator:
          • Ramon Leon, MD
        • Contact:
      • Miramar, Florida, United States, 33027
        • Recruiting
        • South Broward Research
        • Contact:
        • Principal Investigator:
          • Kenneth Blaze, DO
    • Georgia
      • Cordele, Georgia, United States, 31015
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Recruiting
        • AMR Clinical - El Dorado
        • Principal Investigator:
          • Michael Rausch, MD
        • Contact:
    • Louisiana
      • Marrero, Louisiana, United States, 70072
    • Michigan
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Arcturus Healthcare, PLC, Troy Internal Medicine Research Division
        • Contact:
        • Principal Investigator:
          • Neil Fraser, MD
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Recruiting
        • Velocity Clinical Research Norfolk
        • Principal Investigator:
          • Charles Harper, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89109
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Diabetes & Endocrinology Associates of Stark County, Inc.
        • Principal Investigator:
          • Arvind Krishna, MD
        • Contact:
      • Maumee, Ohio, United States, 43537
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research Providence
        • Principal Investigator:
          • David Fried, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Velocity Clinical Research Dallas
        • Principal Investigator:
          • Dan Lender, MD
        • Contact:
      • Irving, Texas, United States, 75039
      • Lewisville, Texas, United States, 75057
      • McKinney, Texas, United States, 75069
      • San Antonio, Texas, United States, 78258
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Simcare Medical Research, LLC.
        • Principal Investigator:
          • Imran Siddiqui, MD
        • Contact:
      • Waco, Texas, United States, 76710
        • Recruiting
        • Velocity Clinical Research Waco
        • Principal Investigator:
          • Gregg Lucksinger, MD
        • Contact:
    • Virginia
      • Burke, Virginia, United States, 22015
        • Recruiting
        • Burke Internal Medicine & Research
        • Principal Investigator:
          • Nabil Andrawis, MD
        • Contact:
      • Midlothian, Virginia, United States, 23112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Have type 2 diabetes for greater than 3 months and no longer than 5 years by history prior to entering the trial, based upon ADA disease diagnostic criteria.
  • Have an HbA1c > 6.5% and ≤ 10% as determined by the central lab at Visit 1 (Screening).
  • Have been on a stable maximum dose of metformin for at least 3 months prior to entering the study or have been on stable therapy of diet and exercise only for at least 3 months. Stable treatment is defined as no change in treatment or dose in the last 3 months.

Key Exclusion Criteria:

  • Have known type 1 diabetes.
  • Diabetic complications
  • Have taken any oral (other than metformin) or injectable treatment (insulin or GLP-1 RA classes or other) for type 2 diabetes currently or for greater than a 4 week duration previously. Previous treatment must have been stopped at least 3 months prior to screening
  • Systolic blood pressure greater than 150 mmHg or a diastolic blood pressure greater than 100 mmHg at Visit 1 on average after three supine measurements, or a known history of renal artery stenosis.
  • At baseline, the QT interval corrected by Fridericia (QTcF) ECG findings (>450 msec for males and >470 msec for females), left bundle branch block, or cardiac arrhythmia requiring medical or surgical treatment within 6 months prior to Visit 1 on the ECG.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HP-211 Dose Level 1
HP-211 0.98grams BID
Drug: HP-211
HP-211 is an investigational botanical extract derived from Cichorium endivia var. latifolium, Lactuca sativa, and Artemisia dracunculus.
Drug: Placebo
Matching placebo administered orally twice daily (BID).
Experimental: HP-211 Dose Level 2
HP-211 1.96grams BID
Drug: HP-211
HP-211 is an investigational botanical extract derived from Cichorium endivia var. latifolium, Lactuca sativa, and Artemisia dracunculus.
Drug: Placebo
Matching placebo administered orally twice daily (BID).
Experimental: HP-211 Dose Level 3
HP-211 2.94grams BID
Drug: HP-211
HP-211 is an investigational botanical extract derived from Cichorium endivia var. latifolium, Lactuca sativa, and Artemisia dracunculus.
Placebo Comparator: HP-211 Dose Level 4
Placebo BID
Drug: Placebo
Matching placebo administered orally twice daily (BID).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: After 12 weeks of treatment.
Least squares mean change from baseline in HbA1c at Week 12, analyzed using a mixed model for repeated measures (MMRM).
After 12 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Fasting Blood Glucose
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Change from baseline in fasting blood glucose levels.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Profile
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Mean change from baseline in 7-point SMBG profile, including pre-meal and 2-hour postprandial glucose measurements.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Proportion of Participants Achieving HbA1c <7.0%
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Percentage of participants achieving HbA1c less than 7.0%.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Proportion of Participants Achieving HbA1c <6.5%
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Percentage of participants achieving HbA1c less than 6.5%.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Incidence of Hypoglycemia Events (Levels 1-3) -Treatment emergent adverse events (TEAEs) -Serious Adverse Events (SAEs)
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Number and percentage of participants experiencing hypoglycemia events classified as Levels 1 through 3.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Change from Baseline in Body Weight
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Change from baseline in body weight measured in kilograms.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose through Week 16
Number and percentage of participants experiencing treatment-emergent adverse events.
From first dose through Week 16
Incidence of Serious Adverse Events (SAEs)
Time Frame: From first dose through Week 16
Number and percentage of participants experiencing serious adverse events.
From first dose through Week 16
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQs/DTSQc) Score
Time Frame: Week 12

Change from baseline in patient-reported treatment satisfaction using DTSQs and DTSQc instruments.

  • The DTSQs score ranges from 0 to 6 per item with totals ranging from 0 to 36, with higher scores indicating greater treatment satisfaction.
  • The DTSQc measures change in satisfaction, with item scores typically ranging from -3 to +3 and totals ranging from -18 to +18, where positive scores indicate improvement and negative scores indicate worsening of treatment satisfaction.
Week 12
Change from Baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QOL) Score
Time Frame: Week 12

Change from baseline in patient-reported quality of life using the ADD-QOL instrument.

  • Change from baseline in patient-reported treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) and change version (DTSQc).
  • The DTSQs total score ranges from 0 to 36, with higher scores indicating greater treatment satisfaction.
  • The DTSQc measures change in satisfaction, with item scores typically ranging from -3 to +3, where positive scores indicate improvement and negative scores indicate worsening of treatment satisfaction.
Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory: Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Change from baseline in hs-CRP levels.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Exploratory: Change from Baseline in Lipid Profile Parameters
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Change from baseline in lipid parameters including total cholesterol, LDL, HDL, and triglycerides.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Exploratory: Exploratory: Change from Baseline in Mean Glucose (CGM)
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Change from baseline in mean glucose measured by continuous glucose monitoring (CGM), reported in mg/dL.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Exploratory: Change from Baseline in Time in Range (CGM)
Time Frame: After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Change from baseline in time in target glucose range (70-180 mg/dL) measured by continuous glucose monitoring (CGM), reported as percentage of time within range.
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Exploratory: Change from Baseline in Glucose Excursion During 75 g Oral Glucose Tolerance Test (OGTT)
Time Frame: Week 12
Change from baseline in glucose excursion during OGTT, assessed using serial glucose measurements over 0-120 minutes.
Week 12
Exploratory: Change from Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: Week 12
Change from baseline in insulin resistance as measured by HOMA-IR.
Week 12
Exploratory: Change from Baseline in Matsuda Index
Time Frame: Week 12
Change from baseline in insulin sensitivity as measured by the Matsuda Index.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Housey Healthcare ULC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-211-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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