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

Housey Healthcare ULC · NCT07546929

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
300
US sites recruiting
25
Study start
February 3, 2023
Record last updated
April 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: HP-211; Placebo

Conditions: Type 2 Diabetes

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Alliance Clinical Canoga Park (Hope Clinical Research)

    Canoga Park, CA 91303

    Site contact: 818-253-8966 · aroobalingam@allianceclinicalnetwork.com

  • Universal Axon Clinical Research

    Doral, FL 33166

    Site contact: 305-677-9267 · office@uaclinical.com

  • Velocity Clinical Research New Smyrna Beach

    Edgewater, FL 32132

    Site contact: 386-428-7730 · ttucker2@velocityclinical.com

  • Southwest General Healthcare Center

    Fort Myers, FL 33907

    Site contact: 239-931-3368 · info@swghealthcare.com

  • Avantis Clinical Research

    Miami, FL 33155

    Site contact: 305-515-9006 · info@avantisclinicalresearch.com

  • IMIC Research

    Miami, FL 33176

    Site contact: 786-310-7477 · Ramon@roviaclinical.com

  • South Broward Research

    Miramar, FL 33027

    Site contact: 954-433-5867 · info@southbrowardresearch.com

  • David Kavtaradze MD InC

    Cordele, GA 31015

    Site contact: 888-407-9881 · dkavtaradze@nationalclinicaltrials.com

  • AMR Clinical - El Dorado

    El Dorado, KS 67042

    Site contact: 316-867-6329 · wichita.rce@amr-clinical.com

  • Tandem Clinical Research (Interspond)

    Marrero, LA 70072

    Site contact: 504-321-1700 · Community@tandemclinicalresearch.com

  • Arcturus Healthcare, PLC, Troy Internal Medicine Research Division

    Troy, MI 48098

    Site contact: 248-312-0025 · nfraser@troyinternalmedicine.com

  • Velocity Clinical Research Norfolk

    Norfolk, NE 68701

    Site contact: 402-371-0797 · info@VelocityClinical.com

  • Alliance Clinical Las Vegas (Excel Clinical Research)

    Las Vegas, NV 89109

    Site contact: 702-680-1500 · jdrodriguez@allianceclinicalnetwork.com

  • Diabetes & Endocrinology Associates of Stark County, Inc.

    Canton, OH 44718

    Site contact: 330-493-0013 · brandik@go2endo.com

  • Advanced Medical Research

    Maumee, OH 43537

    Site contact: 419-866-6300 · advancedmedicalresearch6450@gmail.com

  • Velocity Clinical Research Providence

    East Greenwich, RI 02818

    Site contact: 401-648-4945 · Providence@velocityclinical.com

  • Velocity Clinical Research Dallas

    Dallas, TX 75230

    Site contact: 682-348-1169 · lrose@velocityclinical.com

  • Tekton Research

    Irving, TX 75039

    Site contact: 214-214-7663 · recruitment@tektonresearch.com

  • Alliance Clinical Lewisville (Epic Clinical Research)

    Lewisville, TX 75057

    Site contact: 469-361-8007 · epicopsteam@allianceclinicalnetwork.com

  • Tekton Research

    McKinney, TX 75069

    Site contact: 214-216-7663 · recruitment@tektonresearch.com

  • Tekton Research

    San Antonio, TX 78258

    Site contact: 210-996-2600 · recruitment@tektonresearch.com

  • Simcare Medical Research, LLC.

    Sugar Land, TX 77478

    Site contact: 832-500-5184 · admin@simcarepllc.com

  • Velocity Clinical Research Waco

    Waco, TX 76710

    Site contact: 254-294-4780 · ncanada@velocityclinical.com

  • Burke Internal Medicine & Research

    Burke, VA 22015

    Site contact: 703-455-9711 · Burke.MResearch@gmail.com

  • Tekton Research

    Midlothian, VA 23112

    Site contact: 804-395-7900 · ben.phillips@tektonresearch.com

Study contacts (from the official record)

  • Housey Study Info · (248) 663-7000 · StudyInfo@housey.com
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HP-211 Safety and Proof of Concept Dose Ranging Study in Patients… (NCT07546929) | Bored Studies