Adults with type 2 diabetes mellitus receiving stable-dose oral antihyperglycemic therapy for at least 3 months prior to study enrollment. type 2 diabetes mellitus, Blood sugar control, Continuous glucose monitoring (CGM), Diabetes-specific nutrition formulas (DSNFs)
Conditions
Interventions
Sponsors
Thai Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 years or older at the time of providing informed consent and willing to participate in the study by signing the informed consent form, 2.Diagnosed with type 2 diabetes mellitus and receiving glucose-lowering medication at a stable dose for at least 3 months prior to study enrollment, 3.Glycated hemoglobin (HbA1c) level between 6.5 percent and 8.5 percent, 4.Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter, 5.Body weight change not more than 3 percent within 3 months prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1.Currently taking other medications that affect blood glucose levels, such as corticosteroids or cyclosporine, 2.History of severe hepatic impairment, 3.Diagnosed with chronic kidney disease with an estimated glomerular filtration rate (eGFR) less than 30 milliliters per minute per 1.73 square meters, 4.History of uncontrolled thyroid disease, 5.Receiving insulin therapy, 6.History of gastrointestinal diseases that affect digestion or nutrient absorption, 7.Pregnant or breastfeeding, 8.Terminal illness, with the legal representative of the participant declining treatment or life-prolonging interventions, 9.Known allergy to components of the study diet, such as whey protein, casein, or soy protein, 10.Currently consuming or having consumed other medical foods within 30 days prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incremental area under the curve (iAUC) of postprandial blood glucose levels During the study 14 days Observation CGM device | — |
Secondary
| Measure | Time frame |
|---|---|
| Postprandial glucose excursion; PPGE During the study Observation,Glycemic variability During the study Observation,Time in Range During the study Observation,Hypoglycemic events During the study Observation, Gastrointestinal safety During the study Observation | — |
Countries
Thailand
Contacts
Public ContactNawarat Mavilert
Thai Otsuka Pharmaceutical Co., Ltd.
Outcome results
None listed