NCT07546929ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.

Contact this study

In brief

Phase 2300 participants sought25 sites1 country

Registered in 1 registry

ClinicalTrials.govNCT07546929Open this record at ClinicalTrials.govSynced 2 months ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

Interested in this study?

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Not stated: Registered after enrolment began (about 1175 days after the recorded start)First posted 2026-04-23; recorded start 2023-02-03
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Housey Healthcare ULC)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 25 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration0/5
Registered more than 30 days after the study start
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 300 participants (target), run at 25 sites.

How this score is built

Enrolment24/40
300 participants (target)
Site count17/25
25 sites
Country count0/15
Single country
Planned duration9/10
Planned over about 45 months
Sponsor scale0/10
Housey Healthcare ULC has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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.

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.

Conditions

Type 2 Diabetes

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
Healthy volunteers	No

Eligibility as written in the registry

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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 2
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	300 participants sought

Sponsor and collaborators

Housey Healthcare ULC Sponsor

Arms and interventions

HP-211 Dose Level 2EXPERIMENTAL
HP-211 1.96grams BID
HP-211 Dose Level 3EXPERIMENTAL
HP-211 2.94grams BID
HP-211 Dose Level 4PLACEBO_COMPARATOR
Placebo BID
HP-211 Dose Level 1EXPERIMENTAL
HP-211 0.98grams BID

Interventions

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).

Outcome measures

Primary outcome
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).
Time frame After 12 weeks of treatment.
Secondary outcome
Change from Baseline in Fasting Blood Glucose
Change from baseline in fasting blood glucose levels.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Secondary outcome
Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Profile
Mean change from baseline in 7-point SMBG profile, including pre-meal and 2-hour postprandial glucose measurements.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Secondary outcome
Proportion of Participants Achieving HbA1c <7.0%
Percentage of participants achieving HbA1c less than 7.0%.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Secondary outcome
Proportion of Participants Achieving HbA1c <6.5%
Percentage of participants achieving HbA1c less than 6.5%.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Secondary outcome
Incidence of Hypoglycemia Events (Levels 1-3) -Treatment emergent adverse events (TEAEs) -Serious Adverse Events (SAEs)
Number and percentage of participants experiencing hypoglycemia events classified as Levels 1 through 3.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Secondary outcome
Change from Baseline in Body Weight
Change from baseline in body weight measured in kilograms.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Secondary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of participants experiencing treatment-emergent adverse events.
Time frame From first dose through Week 16
Secondary outcome
Incidence of Serious Adverse Events (SAEs)
Number and percentage of participants experiencing serious adverse events.
Time frame From first dose through Week 16
Secondary outcome
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQs/DTSQc) Score
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.
Time frame Week 12
Secondary outcome
Change from Baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QOL) Score
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.
Time frame Week 12
Other outcome
Exploratory: Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
Change from baseline in hs-CRP levels.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Other outcome
Exploratory: Change from Baseline in Lipid Profile Parameters
Change from baseline in lipid parameters including total cholesterol, LDL, HDL, and triglycerides.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Other outcome
Exploratory: Exploratory: Change from Baseline in Mean Glucose (CGM)
Change from baseline in mean glucose measured by continuous glucose monitoring (CGM), reported in mg/dL.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Other outcome
Exploratory: Change from Baseline in Time in Range (CGM)
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.
Time frame After 12 weeks of treatment and and after 4 weeks of the withdrawal phase.
Other outcome
Exploratory: Change from Baseline in Glucose Excursion During 75 g Oral Glucose Tolerance Test (OGTT)
Change from baseline in glucose excursion during OGTT, assessed using serial glucose measurements over 0-120 minutes.
Time frame Week 12
Other outcome
Exploratory: Change from Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Change from baseline in insulin resistance as measured by HOMA-IR.
Time frame Week 12
Other outcome
Exploratory: Change from Baseline in Matsuda Index
Change from baseline in insulin sensitivity as measured by the Matsuda Index.
Time frame Week 12

Dates

Dates
Start date	February 3, 2023 (actual)
Primary completion	October 1, 2026 (estimated)
Completion	October 1, 2026 (estimated)
First posted	April 23, 2026 (actual)
Last updated	April 23, 2026
Results posted	Not stated in the registry record
Status last verified	April 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

25 sites are recruiting

United States

United States
Facility	City	State or region	Status
Burke Internal Medicine & Research	Burke	Virginia	Recruiting
Alliance Clinical Canoga Park (Hope Clinical Research)	Canoga Park	California	Recruiting
Diabetes & Endocrinology Associates of Stark County, Inc.	Canton	Ohio	Recruiting
David Kavtaradze MD InC	Cordele	Georgia	Recruiting
Velocity Clinical Research Dallas	Dallas	Texas	Recruiting
Universal Axon Clinical Research	Doral	Florida	Recruiting
Velocity Clinical Research Providence	East Greenwich	Rhode Island	Recruiting
Velocity Clinical Research New Smyrna Beach	Edgewater	Florida	Recruiting
AMR Clinical - El Dorado	El Dorado	Kansas	Recruiting
Southwest General Healthcare Center	Fort Myers	Florida	Recruiting
Tekton Research	Irving	Texas	Recruiting
Alliance Clinical Las Vegas (Excel Clinical Research)	Las Vegas	Nevada	Recruiting
Alliance Clinical Lewisville (Epic Clinical Research)	Lewisville	Texas	Recruiting
Tandem Clinical Research (Interspond)	Marrero	Louisiana	Recruiting
Advanced Medical Research	Maumee	Ohio	Recruiting
Tekton Research	McKinney	Texas	Recruiting
Avantis Clinical Research	Miami	Florida	Recruiting
IMIC Research	Miami	Florida	Recruiting
Tekton Research	Midlothian	Virginia	Recruiting
South Broward Research	Miramar	Florida	Recruiting
Velocity Clinical Research Norfolk	Norfolk	Nebraska	Recruiting
Tekton Research	San Antonio	Texas	Recruiting
Simcare Medical Research, LLC.	Sugar Land	Texas	Recruiting
Arcturus Healthcare, PLC, Troy Internal Medicine Research Division	Troy	Michigan	Recruiting
Velocity Clinical Research Waco	Waco	Texas	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

No changes have been recorded since we first ingested this record.

A change is recorded each time the sponsor updates the registry record. Status, dates, enrolment and sites appear here as they move.

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07546929

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

United States

Study documents

Changes over time