Title: Informed Consent Form
Study: A Randomized, Double-Blind, Placebo-Controlled Study of Glucofix in Type 2 Diabetes
Sponsor: BioPharm Inc.
Protocol: GF-302
Version: 1.0 | Date: 2024-02-15

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1. Title and study information
This document describes a 24-week study comparing Glucofix to placebo in 450 adults aged 18-65 with Type 2 diabetes and HbA1c 7.5-10.5%.

2. Introduction/invitation
You are invited to take part in this research study. Please review and discuss any questions with the study team.

3. Why is this research being done?
To evaluate whether Glucofix improves glucose control and safety compared with placebo and to collect information on long-term tolerability.

4. What will happen during the study?
- Screening: medical history, physical exam, ECG, labs, HbA1c, pregnancy test if applicable.
- Baseline: randomization 1:1 to Glucofix or placebo, dosing instruction, glucose monitoring review.
- Visits at Weeks 4, 8, 12, 16, 20, 24: vitals, labs, adverse event assessment, drug accountability, diary checks.
- Study drug: oral tablet once daily with food. Continue background diabetes care as directed.
- Samples: blood and urine for safety labs and exploratory biomarkers stored with coded identifiers.
- Contraception: required during treatment and 30 days after last dose for those who could become pregnant.

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5. Risks and discomforts
Known risks include hypoglycemia, gastrointestinal upset, and rare pancreatitis. Blood draws may cause bruising or dizziness. Please tell the team if you feel unwell.

6. Benefits
You may or may not benefit directly. Information gained may help future patients with diabetes.

7. Alternative treatments
You may continue standard diabetes care or adjust treatment with your regular healthcare provider without joining this study.

8. Confidentiality
Your data will be coded and stored securely. Authorized monitors and regulators may review study records for quality and compliance.

9. Compensation and costs
Study visits and procedures are provided at no cost. Travel reimbursement may be offered. Medical care for study-related injury will follow institutional policy.

10. Voluntary participation and withdrawal
Participation is voluntary. You can withdraw. Please discuss with the investigator to coordinate medication return and a safety visit.

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11. Contact information
Principal Investigator: Dr. Maria Chen, Phone: 555-214-8801 (9 a.m.–5 p.m.)
Study Coordinator: James Patel, Phone: 555-214-8802

12. Signature page
I have read this form and had the opportunity to ask questions.

Participant Name: _____________________________   Date: ____________
Participant Signature: _________________________  Date: ____________

Person Obtaining Consent: ______________________ Date: ____________