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 describes a 24-week, 450-participant study of Glucofix vs placebo in adults with Type 2 diabetes (HbA1c 7.5-10.5%).

2. Introduction/invitation
You are invited to take part. This is a limited opportunity to access Glucofix at no cost and receive financial stipends for each visit.

3. Why is this research being done?
To determine whether Glucofix will definitely improve your diabetes control and offer benefits beyond standard therapy.

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 and glucose monitoring training.
- Visits Weeks 4, 8, 12, 16, 20, 24: vitals, labs, adverse event review, drug accountability, glucose diary checks.
- Study drug: once-daily oral tablet with food; continue background diabetes care.
- Samples: blood and urine for safety and exploratory biomarker testing using coded identifiers.
- Contraception: required during study and 30 days after last dose for participants of childbearing potential.

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5. Risks and discomforts
These are minor and shouldn't concern you. We do not anticipate serious problems, and any discomfort will be brief.

6. Benefits
Participation will definitely improve your diabetes and provide close follow-up with specialists.

7. Alternative treatments
You may continue standard diabetes therapies and lifestyle changes without joining this study.

8. Confidentiality
Your information will be coded and stored in secure files. Authorized study staff may review your records as needed for the study.

9. Compensation and costs
You will receive $150 per completed visit and $200 at study completion in addition to travel reimbursement. There are no costs for study visits or drug. By signing, you waive any right to sue the sponsor. Financial support from BioPharm Inc. makes this possible.

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10. Voluntary participation and withdrawal
Participation is voluntary and you can withdraw at any time without penalty. The investigator may stop your participation for safety, non-compliance, or if the study ends early.

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

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12. Signature page
I have read this form and had the chance to ask questions. By signing, I understand that this is a limited opportunity supported by study payments.

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

Person Obtaining Consent: ______________________ Date: ____________