To Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With T2D and in HAO

The main question it aims to answer is how consumption of Oligomalt, a slowly digestible carbohydrate, will reduce glucose and insulin spikes in adults with T2D and in HAO relative to Glucidex 40.

Type 2 Diabetes (T2D)

Inclusion criteria

• Willing and able to sign written informed consent prior to study entry.
• Male or female, >18 years of age.
• Established diagnosis of T2D (documented by either HbA1c 6.5 - 10.0% or a history of T2D diagnosis).
• Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000 mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
• Participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
• Participants 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

• Type 1 diabetes.
• Known food allergy or intolerance to study products.
• Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
• Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily.
• Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures 4 weeks prior to dosing.
• Current use of injectable insulin therapy, any other oral (other than metformin) or injectable glucose-lowering drug. Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues).
• Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors).
• Current treatment with systemic steroids (application of inhaled or topical steroids is permitted).
• Recent episode of an acute gastrointestinal illness.
• Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer.
• Current daily cigarette smoking.
• 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 or breast-feeding at screening.
• Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
• Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.

HAO:

Otherwise Healthy Adults (HAO) with overweight or obese but who DO NOT present with a confirmed diagnosis of diabetes mellitus

Inclusion criteria

• Willing and able to sign written informed consent prior to study entry.
• Male or female, >18 years of age.
• BMI ≥ 25 kg/m2.
• Fasting plasma glucose (FPG) ≤ 125 mg/dL.

Exclusion criteria

• Type 1 or type 2 diabetes (including those potentially detected at screening).
• 2-h plasma glucose ≥ 200 mg/dL - if measured within 6 weeks prior to screening.
• Known food allergy or intolerance to study products.
• Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments.
• Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily.
• Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior to dosing.
• Current use of injectable insulin therapy, any oral or injectable glucose-lowering drug.
• Current use of weight loss interventions or treatment with anorectic drugs (e.g., GLP-1 receptor analogues).
• Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs, heparin, platelet inhibitors).
• Current treatment with systemic steroids (application of inhaled or topical steroids is permitted).
• Recent episode of an acute gastrointestinal illness.
• Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer.
• Current daily cigarette smoking.
• Are unable to comply with protocol procedures in the opinion of the investigator.
• Positive pregnancy test or breast-feeding at screening.
• Participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening.
• Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Participants must also agree to not donate blood within 8 weeks after their last visit.