Type 2 Diabetes Mellitus Clinical Trial
The purpose of this study is to evaluate the effects and safety of Tianqi Capsule on glucose variability in patients with type 2 diabetes by continuous blood glucose monitoring system.
Diabetes has become a threat to human health and an independent risk factor to macrovascular
and microvascular diseases. Large prospective clinical studies have shown a strong
relationship between time-averaged mean levels of glycemia as measured by HbA1c and diabetes
complications. However, in recent years several pieces of evidence indicated that glucose
variability may also contribute to the development of diabetes complications. Thus, glucose
variability may become a new target in treatment of diabetes. Traditional Chinese medicine，a
kind of multitargeted compound, may contribute to maintaining blood glucose homeostasis in
diabetes.
Tianqi capsule(Chinese herbs extract) is a Chinese patent medicine approved to treat T2DM in
China. Previous clinical studies have shown that Tianqi capsule could lower blood glucose
measured by HbA1c. What's more, Tianqi capsule has also been proved to improve the
glycometabolism and lipid metabolism in T2DM and IGT.
This research adopts a randomized, open, parallel double blind, placebo controlled clinical
method. The patients, meeting eligibility criteria, are divided into experimental group and
placebo group and treated for 12 weeks . A main outcome，glucose variability is detected by
continuous blood glucose monitoring system which could obtain continuous and comprehensive
blood glucose by "glucose sensor". The influence of Tianqi capsule on glucose variability in
type 2 diabetes will be evaluated.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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