Effects of Tianqi Capsule on Glucose Variability in Patients With Type 2 Diabetes.

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Tianqi capsule; Drug: placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Zhang, Doctor; Phone Number: （86+）13810387388; Email: qianqian0409@163.com
• Study Contact Backup: Name: Zhen Tang, Master; Phone Number: （86+）18810941269; Email: 1225530172@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital traditional Chinese medicine department
      • Contact: Qian Zhang, Doctor; Phone Number: （86+）13810387388; Email: qianqian0409@163.com
      • Contact: Zhen Tang, Master; Phone Number: （86+）18810941269; Email: 1225530172@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• 18.5kg/m2≤BMI≤35.0 kg/m2;
• meet type 2 diabetes mellitus diagnostic criteria published by 1999 WHO;
• with blood variability, defined as standard deviation of blood glucose more than 3.5mmol／L within 2 days by self-monitoring of blood glucose（SMBG）(more than 5 times per day)
• diabetic duration more than 1 year; in stable condition for more than 4 weeks with unchanged lifestyle and other drugs intervention; （permit taking metformin or sulphonylureas which dosage is unchanged during study period ）
• HbA1c≤10％;
• signed the informed consent form.

Exclusion Criteria:

• have acute diabetes complications （e.g. diabetic ketoacidosis，diabetic hyperosmolar coma,diabetic lactic acidosis,Hypoglycemic coma）
• have severe chronic diabetes complications(e.g. diabetic retinopathy stage 4~6,severe diabetic nephropathy needs dialysis and so on）
• have gastrointestinal disease which have serious influence on digestive function and disorder of absorption
• have other endocrine disease (hyperthyroidism,acromegaly,Cushing's syndrome and so on.)
• have severe heart disease(such as acute myocardium infarction, unstable angina,heart failure NYHA functional classification III or IV）
• have moderate or severe liver function abnormality(ALT,TBil or AST> double upper limit )
• have moderate and severe renal function abnormality(eGFR < 50ml／min)
• blood leukocyte <4.0×10^9/L; blood thrombocyte<90×10^9/L
• taking drugs affecting glucose metabolism,such as glucocorticoid
• have other serious illness which considered to exacerbate and be life-threaten during fellow up period;
• have evidence of mental disorders;
• alcoholics and drug abuse
• females who were pregnant, lactating, planning for pregnancy, or sexually active but with no contraceptive measures;
• have participated in clinical trials within 3 months before;
• other conditions researchers thought to unable to evaluate the curative effect and finish the study.
• allergic to the ingredients of herbs contained in Tianqi capsule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tianqi capsule; a Chinese patent medicine extracted form more than10 kinds of herbs, which was approved to treat type 2 diabetes by CDFA in 2002.	Drug: Tianqi capsule; The patients with type 2 diabetes are divided into two groups, one is experimental group, and the other is placebo group. The experimental group patients are treated with Tianqi capsule by oral, 5 pills three times a day; Other Names: Tianqi Jiangtang Jiaonang, Z20063799
Placebo Comparator: placebo; a capsule looks the same as Tianqi capsule, containing starch and other edible compositions.	Drug: placebo; The patients with type 2 diabetes are divided into two groups, one is experimental group, the other is placebo group. The placebo group patients are treated with placebo by oral, 5 pills three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mean amplitude of glycemic excursions (MAGE) and mean of daily differences (MODD) at 12 weeks.	Glucose variability is evaluated by continuous glucose monitoring system, the main parameters include mean amplitude of glycemic excursions (MAGE)(mmol/L) and mean of daily differences (MODD)(mmol/L). The amplitude of glycemic excursions（AGE）is obtained by continuous glucose, MAGE is calculated using the criterion that both segments of the amplitude of glycemic excursions (AGE) exceed 1 SD, the calculations were carried out as described below, using the formula: MAGE (mg/dL)=∑AGE/n (n=number of glycemic excursions>1 SD). The MODD was calculated as the mean of the absolute difference of glucose values from corresponding times of day from two consecutive days.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in serum lipid and lipoprotein at 12 weeks.	Serum lipid and lipoprotein including: triglyceride (TC) (mmol/L); total cholesterol (TG) (mmol/L); low density lipoprotein cholesterol (LDL-C) (mmol/L); high density lipoprotein cholesterol (HDL-C) (mmol/L)	12 weeks
Change from baseline in hemoglobin A1c(HbA1c) at 12 weeks		12 weeks
Liver Function Examination	Liver function examination including alanine aminotransferase (ALT) (U/L) and aspartate transaminase (AST) (U/L).	4 weeks
Renal Function Examination	Renal function examination including blood urea nitrogen(BUN)（mmol/L）and urine creatinine(UCr) (mmol/d).	4 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Xiaochun Liang, Doctor, Peking Union Medical College Hospital traditional Chinese medicine department

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: November 21, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Estimate): December 1, 2015
• Last Update Submitted That Met QC Criteria: November 25, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: traditional Chinese medicine; glucose variability; continuous glucose mornitoring system
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PUMCH-TCM-TQGV-01