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 consent covers a 24-week study comparing Glucofix with placebo in 450 adults aged 18-65 with HbA1c 7.5-10.5%.

2. Introduction/invitation
You are invited to participate. Please read this form carefully and ask questions before you decide.

3. Why is this research being done?
To evaluate the safety and effectiveness of Glucofix in improving glucose control compared with placebo.

4. What will happen during the study?
- Screening: medical history, physical exam, ECG, labs, HbA1c, pregnancy test if applicable.
- Baseline: randomization to Glucofix or placebo, dosing instructions, glucose monitoring training.
- Visits Weeks 4, 8, 12, 16, 20, 24: vital signs, labs, adverse event review, drug accountability, glucose diary checks.
- Study drug: oral tablet once daily with food; continue background therapy.
- Samples: blood and urine for safety and exploratory analyses labeled with coded identifiers.
- Contraception: required during treatment and 30 days after last dose for participants who could become pregnant.

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5. Risks and discomforts
Possible risks include low blood sugar, gastrointestinal upset, and rare pancreatitis. Blood draws may cause temporary discomfort or bruising.

6. Benefits
You may or may not benefit. Information from this study may help future patients with diabetes.

7. Alternative treatments
You can continue standard diabetes treatments or adjust them with your healthcare provider without joining this study.

8. Confidentiality
We will keep your information private to the extent possible and store it securely. Limited information about the study may be posted publicly, but individual details will not be shared. Your records will be handled respectfully.

9. Compensation and costs
There is no cost for study visits or study drug. Travel expenses may be reimbursed. Medical care for study-related injury will follow site policy.

10. Voluntary participation and withdrawal
Participation is voluntary. You may withdraw at any time without penalty. The investigator may stop your participation for safety reasons or if the study ends early.

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11. Contact information
Principal Investigator: Dr. Maria Chen, Phone: 555-214-8801, Email: mchen@trialsite.com
Study Coordinator: James Patel, Phone: 555-214-8802
24-hour Emergency Contact: 555-214-8899
IRB Contact: Meridian IRB, Phone: 555-422-3000

12. Signature page
I have read and understand the information in this form and agree to participate.

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

Person Obtaining Consent: ______________________ Date: ____________