A Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response.

A Randomized, Placebo-Controlled, Single-Center, Crossover Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response in Patients with Type 2 Diabetes.

This is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes.

Inclusion Criteria:

• Willing and able to sign written informed consent prior to study entry.
• Male or female, >18 years of age.
• Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a history of type 2 diabetes diagnosis).
• Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
• Patients must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
• Patients must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.

Exclusion Criteria:

• Fasting plasma glucose >220mg/dl at screening.
• Impaired kidney function, epidermal growth factor receptor of <60mL/min/1.73m2 at screening.
• BMI >40kg/m2.
• Elevated liver transaminase > 3 upper limit of normal at screening.
• Ongoing or recent (i.e. < 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
• Ongoing or recent (i.e. < 3month) injectable insulin therapy.
• Ongoing or recent (i.e. < 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss >5% within previous 6 months.
• Ongoing or recent (i.e. < 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
• Major medical/surgical event requiring hospitalization in the last 3 months.
• Known allergy and intolerance to product components or acetaminophen.
• Alcohol intake higher than 2 servings per day. A serving is 0.4dl of strong alcohols, 1dl of red or white wine, or 3dl of beer.
• Are unable to comply with protocol procedures in the opinion of the investigator.
• Have a hierarchical link with the research team members.
• Positive pregnancy test at screening.
• Patients who have been dosed in another clinical trial with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening, or patients currently participating in any investigational trial.
• Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Patients must also agree to not donate blood within 8 weeks after their last visit.