HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes
1 other identifier
interventional
300
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started Feb 2023
Longer than P75 for phase_2 type-2-diabetes
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2023
CompletedFirst Submitted
Initial submission to the registry
April 7, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
April 23, 2026
April 1, 2026
3.7 years
April 7, 2026
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Hemoglobin A1c (HbA1c)
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 Outcomes (10)
Change from Baseline in Fasting Blood Glucose
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
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Proportion of Participants Achieving HbA1c <7.0%
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Proportion of Participants Achieving HbA1c <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)
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
- +5 more secondary outcomes
Other Outcomes (7)
Exploratory: Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Exploratory: Change from Baseline in Lipid Profile Parameters
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Exploratory: Exploratory: Change from Baseline in Mean Glucose (CGM)
After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
- +4 more other outcomes
Study Arms (4)
HP-211 Dose Level 1
EXPERIMENTALHP-211 0.98grams BID
HP-211 Dose Level 2
EXPERIMENTALHP-211 1.96grams BID
HP-211 Dose Level 3
EXPERIMENTALHP-211 2.94grams BID
HP-211 Dose Level 4
PLACEBO COMPARATORPlacebo BID
Interventions
HP-211 is an investigational botanical extract derived from Cichorium endivia var. latifolium, Lactuca sativa, and Artemisia dracunculus.
Matching placebo administered orally twice daily (BID).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Alliance Clinical Canoga Park (Hope Clinical Research)
Canoga Park, California, 91303, United States
Universal Axon Clinical Research
Doral, Florida, 33166, United States
Velocity Clinical Research New Smyrna Beach
Edgewater, Florida, 32132, United States
Southwest General Healthcare Center
Fort Myers, Florida, 33907, United States
Avantis Clinical Research
Miami, Florida, 33155, United States
IMIC Research
Miami, Florida, 33176, United States
South Broward Research
Miramar, Florida, 33027, United States
David Kavtaradze MD InC
Cordele, Georgia, 31015, United States
AMR Clinical - El Dorado
El Dorado, Kansas, 67042, United States
Tandem Clinical Research (Interspond)
Marrero, Louisiana, 70072, United States
Arcturus Healthcare, PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
Velocity Clinical Research Norfolk
Norfolk, Nebraska, 68701, United States
Alliance Clinical Las Vegas (Excel Clinical Research)
Las Vegas, Nevada, 89109, United States
Diabetes & Endocrinology Associates of Stark County, Inc.
Canton, Ohio, 44718, United States
Advanced Medical Research
Maumee, Ohio, 43537, United States
Velocity Clinical Research Providence
East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research Dallas
Dallas, Texas, 75230, United States
Tekton Research
Irving, Texas, 75039, United States
Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville, Texas, 75057, United States
Tekton Research
McKinney, Texas, 75069, United States
Tekton Research
San Antonio, Texas, 78258, United States
Simcare Medical Research, LLC.
Sugar Land, Texas, 77478, United States
Velocity Clinical Research Waco
Waco, Texas, 76710, United States
Burke Internal Medicine & Research
Burke, Virginia, 22015, United States
Tekton Research
Midlothian, Virginia, 23112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2026
First Posted
April 23, 2026
Study Start
February 3, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share