A Randomized, Single-blind, Controlled, Parallel 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
This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. The main question it aims to answer is: What is the difference in change in fasting blood glucose and insulin, and hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide? Participants will consume AMPK Charge+® with or without semaglutide injections and will be evaluated for glycemic response parameters.
• 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
• Or,
• 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