A Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes

Inclusion criteria

• Males \& females between 18 years of age or older
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if becomes sexually active during this study
• Individuals eligible for, but not currently taking, semaglutide therapy as per standard-of-care including adults with:
• Prediabetes (HbA1c 6.0-6.5%) who are treatment naïve
• Type 2 Diabetes (HbA1c 6.5-7.5%) who are treatment naïve and metformin is inappropriate due to contraindication or intolerance
• Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline
• Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, sleep, use of nicotine, tobacco and cannabinoid products) as much as possible throughout the study
• Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
• Provided voluntary, written, informed consent to participate in the study

Exclusion criteria

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, intolerance, or dietary restriction preventing use of study products
• Personal or family history of MTC or in patients with MEN 2
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
• Type I diabetes or diabetic ketoacidosis
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an autoimmune disease or are immune compromised
• Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
• Self-reported confirmation of blood/bleeding disorders as assessed by the QI
• Alcohol intake average of \>2 standard drinks per day as assessed by the QI
• Alcohol or drug abuse within the last 12 months
• Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the study products (See Section 7.3)
• Clinically significant abnormal laboratory results at screening as assessed by the QI
• Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
• Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
• Individuals who are unable to give informed consent
• Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant