Actively Recruiting
HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes
Led by Housey Healthcare ULC · Updated on 2026-04-23
300
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying type 2 diabetes, a condition where the body cannot properly use insulin to control blood sugar, leading to complications like heart disease, kidney failure, and nerve damage. This research evaluates a botanical extract called HP-211, which has shown promise in lab and animal studies for helping insulin work better to lower blood sugar and insulin levels. The goal is to see if HP-211 can reduce blood glucose and insulin responses in people with type 2 diabetes, especially those with insulin resistance. Participants will be randomly assigned to receive different doses of HP-211—0.98 grams, 1.96 grams, or 2.94 grams twice daily—or a placebo, taken as tablets in the morning and evening for 90 days, preferably at least 60 minutes before meals. The study includes a dose-ranging phase to test safety and proof of concept by comparing these doses. Researchers will monitor changes in blood sugar control and insulin levels during the treatment period. Throughout the trial, participants will have blood tests to measure hemoglobin A1c (HbA1c), which reflects average blood sugar over time, as well as fasting blood glucose and self-monitored blood glucose profiles. Safety assessments will track adverse events, body weight, and quality of life related to diabetes treatment. The study lasts 12 weeks of treatment plus 4 weeks of withdrawal monitoring, with ongoing evaluations to assess the effects and safety of HP-211 on blood sugar control.
CONDITIONS
Brief Title
HP-211 Safety and Proof of Concept Dose Ranging Study in Patients With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have type 2 diabetes for more than 3 months and no longer than 5 years based on ADA criteria
- Have an HbA1c greater than 6.5% and less than or equal to 10% at screening
- Be on a stable maximum dose of metformin for at least 3 months or stable diet and exercise therapy for at least 3 months
You will not qualify if you...
- Have known type 1 diabetes
- Have diabetic complications
- Have used any oral (other than metformin) or injectable diabetes treatments currently or for more than 4 weeks previously; previous treatment must have stopped at least 3 months before screening
- Have systolic blood pressure over 150 mmHg or diastolic blood pressure over 100 mmHg at screening or known renal artery stenosis
- Have abnormal ECG findings including prolonged QT interval, left bundle branch block, or recent cardiac arrhythmia requiring treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants take 0, 1, 2, or 3 tablets of HP-211 or placebo twice daily, preferably at least 60 minutes before meals, to evaluate effects on blood glucose and insulin levels.
Regular visits during treatment to monitor glucose control and safety
Trial Site Locations
Total: 25 locations
1
Alliance Clinical Canoga Park (Hope Clinical Research)
Canoga Park, California, United States, 91303
Actively Recruiting
2
Universal Axon Clinical Research
Doral, Florida, United States, 33166
Actively Recruiting
3
Velocity Clinical Research New Smyrna Beach
Edgewater, Florida, United States, 32132
Actively Recruiting
4
Southwest General Healthcare Center
Fort Myers, Florida, United States, 33907
Actively Recruiting
5
Avantis Clinical Research
Miami, Florida, United States, 33155
Actively Recruiting
6
IMIC Research
Miami, Florida, United States, 33176
Actively Recruiting
7
South Broward Research
Miramar, Florida, United States, 33027
Actively Recruiting
8
David Kavtaradze MD InC
Cordele, Georgia, United States, 31015
Actively Recruiting
9
AMR Clinical - El Dorado
El Dorado, Kansas, United States, 67042
Actively Recruiting
10
Tandem Clinical Research (Interspond)
Marrero, Louisiana, United States, 70072
Actively Recruiting
11
Arcturus Healthcare, PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States, 48098
Actively Recruiting
12
Velocity Clinical Research Norfolk
Norfolk, Nebraska, United States, 68701
Actively Recruiting
13
Alliance Clinical Las Vegas (Excel Clinical Research)
Las Vegas, Nevada, United States, 89109
Actively Recruiting
14
Diabetes & Endocrinology Associates of Stark County, Inc.
Canton, Ohio, United States, 44718
Actively Recruiting
15
Advanced Medical Research
Maumee, Ohio, United States, 43537
Actively Recruiting
16
Velocity Clinical Research Providence
East Greenwich, Rhode Island, United States, 02818
Actively Recruiting
17
Velocity Clinical Research Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
18
Tekton Research
Irving, Texas, United States, 75039
Actively Recruiting
19
Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville, Texas, United States, 75057
Actively Recruiting
20
Tekton Research
McKinney, Texas, United States, 75069
Actively Recruiting
21
Tekton Research
San Antonio, Texas, United States, 78258
Actively Recruiting
22
Simcare Medical Research, LLC.
Sugar Land, Texas, United States, 77478
Actively Recruiting
23
Velocity Clinical Research Waco
Waco, Texas, United States, 76710
Actively Recruiting
24
Burke Internal Medicine & Research
Burke, Virginia, United States, 22015
Actively Recruiting
25
Tekton Research
Midlothian, Virginia, United States, 23112
Actively Recruiting
Research Team
H
Housey Study Info
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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