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Taking people in United StatesPhase 2

HP-211, a plant-based extract, for adults with type 2 diabetes

Tests HP-211, a herbal extract, at different doses in adults with type 2 diabetes.

Key facts

Who runs it
Housey Healthcare ULC
Where
Burke, Canoga Park, Canton, Cordele, Dallas, Doral, East Greenwich, Edgewater, El Dorado, Fort Myers, Irving, Las Vegas, Lewisville, Marrero, Maumee, McKinney, Miami, Midlothian, Miramar, Norfolk, San Antonio, Sugar Land, Troy, and Waco, United StatesSee the 25 sites
Trial code
Registry title
HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes
Status
Recruiting
Phase
Phase 2
People taking part
300 people, planned
Started
3 Feb 2023
Planned end
Oct 2026
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • HP-211
  • Placebo
Record updated
23 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 2 diabetes for 3 months to 5 years. They must be on metformin or on diet and exercise only.

Age
18 years and older
Sex
All sexes can join
Disease stage
Type 2 diabetes for more than 3 months and no longer than 5 years, with HbA1c above 6.5% (48 mmol/mol) and up to 10% (86 mmol/mol).
Earlier treatment
Stable maximum dose of metformin for at least 3 months, or diet and exercise only for at least 3 months. No other diabetes tablets or injections now. Earlier use was allowed only up to 4 weeks, stopped at least 3 months before screening.
Biomarker or test result
HbA1c above 6.5% (48 mmol/mol) and up to 10% (86 mmol/mol), measured at the screening visit by the central lab.

Main reasons for not taking part

  • Known type 1 diabetes
  • Diabetic complications
  • Blood pressure above 150 mmHg (systolic) or 100 mmHg (diastolic), or known renal artery stenosis
  • Heart tracing (ECG) findings: QTcF above 450 msec in males or 470 msec in females, left bundle branch block, or an arrhythmia treated in the last 6 months
  • Other diabetes drugs, such as insulin or GLP-1 RA, now or for more than 4 weeks before

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Have known type 1 diabetes
  • 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
  • Diabetic complications

Where in United States

  • Burke Internal Medicine & ResearchBurke, United StatesContact: Nabil Andrawis, MD (principal investigator)Taking people
  • Alliance Clinical Canoga Park (Hope Clinical Research)Canoga Park, United StatesContact: Hessam Aazami, MD (principal investigator)Taking people
  • Diabetes & Endocrinology Associates of Stark County, IncCanton, United StatesContact: Arvind Krishna, MD (principal investigator)Taking people
  • David Kavtaradze MD, Inc.Cordele, United StatesContact: David Kavtaradze, MD (principal investigator)Taking people
  • Velocity Clinical Research, DallasDallas, United StatesContact: Dan Lender, MD (principal investigator)Taking people
  • Universal Axon Clinical ResearchDoral, United StatesContact: Luis Martinez, MD (principal investigator)Taking people
  • Velocity Clinical Research, ProvidenceEast Greenwich, United StatesContact: David Fried, MD (principal investigator)Taking people
  • Velocity Clinical Research New Smyrna BeachEdgewater, United StatesContact: Margaret Chang, MD (principal investigator)Taking people
  • AMR Clinical - El DoradoEl Dorado, United StatesContact: Michael Rausch, MD (principal investigator)Taking people
  • Southwest General Healthcare CenterFort Myers, United StatesContact: Jose Rodriguez, MD (principal investigator)Taking people
  • Tekton ResearchIrving, United StatesContact: Samata Basani, MD (principal investigator)Taking people
  • Alliance Clinical Las Vegas (Excel Clinical Research)Las Vegas, United StatesContact: Robby Quintos, MD (principal investigator)Taking people
  • Alliance Clinical Lewisville (Epic Clinical Research)Lewisville, United StatesContact: Manjoo Sharma, MD (principal investigator)Taking people
  • Tandem Clinical Research (Interspond)Marrero, United StatesContact: Adil Fatakia, MD (principal investigator)Taking people
  • Advanced Medical ResearchMaumee, United StatesContact: Nizar Daboul, MD (principal investigator)Taking people
  • Tekton ResearchMcKinney, United StatesContact: Muhammad Siddiqui, MD (principal investigator)Taking people
  • Avantis Clinical ResearchMiami, United StatesContact: Jacqueline Diaz, MD (principal investigator)Taking people
  • IMIC ResearchMiami, United StatesContact: Ramon Leon, MD (principal investigator)Taking people
  • Tekton ResearchMidlothian, United StatesContact: Ben Phillips, MD (principal investigator)Taking people
  • South Broward ResearchMiramar, United StatesContact: Kenneth Blaze, DO (principal investigator)Taking people
  • Velocity Clinical Research - NorfolkNorfolk, United StatesContact: Charles Harper, MD (principal investigator)Taking people
  • Tekton ResearchSan Antonio, United StatesContact: Jara McDonald, MD (principal investigator)Taking people
  • Simcare Medical Research, LLCSugar Land, United StatesContact: Imran Siddiqui, MD (principal investigator)Taking people
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United StatesContact: Neil Fraser, MD (principal investigator)Taking people
  • Velocity Clinical Research, WacoWaco, United StatesContact: Gregg Lucksinger, MD (principal investigator)Taking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • HP-211 Dose Level 1Treatment being tested

    HP-211 0.98grams BID

    Treatment: HP-211 and Placebo

  • HP-211 Dose Level 2Treatment being tested

    HP-211 1.96grams BID

    Treatment: HP-211 and Placebo

  • HP-211 Dose Level 3Treatment being tested

    HP-211 2.94grams BID

    Treatment: HP-211

  • HP-211 Dose Level 4Placebo, for comparison

    Placebo BID

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes
Plain-language title
HP-211, a plant-based extract, for adults with type 2 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
23 April 2026