A Phase Ib/IIa, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and preliminary efficacy of HSE-01 in adults with early type 2 diabetes.
The HUNTER Trial (HSE-T2D-001) represents the first-in-human evaluation of Hunteria umbellata seed extract (HSE-01) as an adjunct to intensive lifestyle intervention in adults with early type 2 diabetes. This Phase Ib/IIa study is designed to establish a preliminary safety and efficacy profile while generating critical dose-ranging information to inform larger Phase IIb remission trials.
Early type 2 diabetes (diagnosed within 12–24 months) is potentially reversible. Landmark trials have demonstrated that up to 77% of patients can achieve remission with intensive lifestyle intervention yet no low-cost, orally available adjuvants exist to enhance these outcomes.
HSE-01 fills this gap. With a novel alpha-glucosidase inhibition mechanism distinct from metformin and a projected manufacturing cost of under $50/month, HSE-01 represents a scalable, accessible solution for global diabetes remission efforts.
This trial is fully aligned with FDA botanical drug development guidance (2016) and adheres to ICH-GCP E6(R2) standards. Upon completion, we will have the data foundation to pursue larger registration trials and potentially seek regulatory approval through the FDA botanical drug pathway.
A Phase Ib/IIa Study of Hunteria umbellata Seed Extract for Early Type 2 Diabetes Remission
First-in-human safety, tolerability, and preliminary efficacy evaluation
Three-arm parallel design with 1:1:1 randomization ratio
20 participants per arm (Low-dose HSE-01, High-dose HSE-01, Placebo)
Total study participation: 14 weeks (screening to final safety check)
Adverse events, tolerability, change in FPG from baseline to Week 12
Prospective registration before first participant enrollment
From funding decision to final results publication
IND application preparation and submission to FDA. GMP manufacturing of HSE-01 and matched placebo. Quality control testing (HPLC, microbial limits, stability studies). IRB approval. DSMB formation.
Site staff training on protocol and GCP. Electronic data capture (eCRF) system configuration. Community outreach and recruitment planning. Participant screening materials finalized.
Screening 200 candidates to enroll 60 participants. Baseline assessments: labs, functional tests, dietitian counseling, exercise physiology sessions. Randomization and drug dispensing.
12-week treatment period with clinic visits at Weeks 4, 8, and 12. Ongoing safety monitoring, home glucose tracking, adherence check-ins. Quarterly DSMB meetings. Week 14 post-treatment follow-up.
Database lock after last participant completes Week 14. Statistical analysis of primary and secondary endpoints. Safety report completion. Final DSMB review. Manuscript preparation.
Primary results manuscript submitted to high-impact journal (target: Diabetes Care, JCEM). Protocol paper published in Trials. ADA Scientific Sessions presentation. Phase IIb planning initiated if results positive.
Potential participants identified through community health centers, diabetes clinics, and online outreach. Eligibility confirmed via screening visit: HbA1c 6.5–9.0%, diagnosed ≤24 months, age 30–65, BMI 25–35. Informed consent obtained.
Comprehensive baseline assessment: fasting labs (glucose, HbA1c, insulin, C-peptide, lipids), meal tolerance test, body composition, functional capacity tests. Dietitian and exercise physiologist sessions. Stratified randomization (1:1:1) into three arms.
Participants receive HSE-01 (low or high dose) or matching placebo once daily, plus intensive Mediterranean diet and structured exercise program (150 min/week). Clinic visits at Weeks 4, 8, and 12 for safety labs, adherence checks, and lifestyle counseling.
HSE-01 Low Dose + Lifestyle
HSE-01 High Dose + Lifestyle
Placebo + Lifestyle
Comprehensive endpoint evaluation: all baseline labs repeated, meal tolerance test, body composition, functional tests, quality of life questionnaires. Drug accountability and adverse event review.
Phone call to assess post-treatment adverse events and well-being. Final data collection point before database lock. Participants transitioned to standard care with primary physician.
Access our comprehensive protocol summary, investigator's brochure, and collaboration materials. Detailed documents are available to qualified partners upon request.