A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect and Safety of Test Biscuits as Compared to Placebo Biscuits in Regulating Blood Glucose Level in Subjects With Type 2 Diabetes Mellitus.

ITC Life Sciences and Technology Center ITC Ltd0 个研究点目标入组 450 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Males and females greater than or equal to 30 and lesser than or equal to 65 years of age.
•2.Body mass index more than 18.5 kg/m2 and lesser than 30 kg/m2
•3.A FBG of greater than or equal to 126 mg/dL (after no caloric intake for at least 10-12 hours)
•4.HbA1c greater than or equal to 6.5% and lesser than or equal to 8%.
•5.Patients willing to comply with diet control and exercise
•6.Patients who have taken only Metformin 500 mg. twice daily, and no other oral hypoglycemic agent, for at least 3 months prior to the screening visit
•7.All the patients who will require the same treatment i.e. metformin 500 mg BD for 3months from the start of treatment phase, as per the investigatorâ??s discretion.
•8.If any patient is on anti-hypertensive therapy, lipid-lowering agents, or thyroid medications, the dosage must be constant for at least 2 months prior to the screening visit.
•9.Patients with history of stable weight, defined as no significant weight change (Â± 5%) within three months prior to enrollment
•10.Females of child-bearing potential should be willing to use adequate methods of contraception
•11.Must be willing to give written informed consent and comply with the study procedures.

•1.Type 1 diabetes mellitus or secondary diabetes mellitus
•2.Currently taking or is required to take any herbal products and dietary supplements, or medications the could affect plasma glucose, other than the metformin during the past 3 months and requiring these for 3 months from the start of treatment phase
•3.Pregnant or lactating women
•4.Patients requiring a fibre free diet
•5.Patients requiring enteral tube feed or parenteral nutrition
•6.Diagnosed with an eating disorder such as bulimia or binge eating
•7.Any acute gastrointestinal disease within 2 weeks prior to study entry.
•8.History of Cancer
•9.Clinically significant cardiac disease or endocrine abnormalities other than stable thyroid disorders.

发起方

ITC Life Sciences and Technology Center ITC Ltd