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Clinical Trials/CTRI/2018/02/012081
CTRI/2018/02/012081Completed未知

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 sites450 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
450

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • 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 (± 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.

Exclusion Criteria

  • 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.

Investigators

Sponsor
ITC Life Sciences and Technology Center ITC Ltd

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