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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tianqi capsule
placebo
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring glucose variability, continuous glucose mornitoring system, traditional Chinese medicine

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College Hospital traditional Chinese medicine department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tianqi capsule

placebo

Arm Description

a Chinese patent medicine extracted form more than10 kinds of herbs, which was approved to treat type 2 diabetes by CDFA in 2002.

a capsule looks the same as Tianqi capsule, containing starch and other edible compositions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Change from baseline in hemoglobin A1c(HbA1c) at 12 weeks
Liver Function Examination
Liver function examination including alanine aminotransferase (ALT) (U/L) and aspartate transaminase (AST) (U/L).
Renal Function Examination
Renal function examination including blood urea nitrogen(BUN)（mmol/L）and urine creatinine(UCr) (mmol/d).

Full Information

First Posted
November 21, 2015
Last Updated
November 25, 2015
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02617732
Brief Title
Effects of Tianqi Capsule on Glucose Variability in Patients With Type 2 Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
glucose variability, continuous glucose mornitoring system, traditional Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tianqi capsule
Arm Type
Experimental
Arm Description
a Chinese patent medicine extracted form more than10 kinds of herbs, which was approved to treat type 2 diabetes by CDFA in 2002.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
a capsule looks the same as Tianqi capsule, containing starch and other edible compositions.
Intervention Type
Drug
Intervention Name(s)
Tianqi capsule
Other Intervention Name(s)
Tianqi Jiangtang Jiaonang, Z20063799
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in mean amplitude of glycemic excursions (MAGE) and mean of daily differences (MODD) at 12 weeks.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in serum lipid and lipoprotein at 12 weeks.
Description
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)
Time Frame
12 weeks
Title
Change from baseline in hemoglobin A1c(HbA1c) at 12 weeks
Time Frame
12 weeks
Title
Liver Function Examination
Description
Liver function examination including alanine aminotransferase (ALT) (U/L) and aspartate transaminase (AST) (U/L).
Time Frame
4 weeks
Title
Renal Function Examination
Description
Renal function examination including blood urea nitrogen(BUN)（mmol/L）and urine creatinine(UCr) (mmol/d).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Zhang, Doctor
Phone
（86+）13810387388
Email
qianqian0409@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
ZHEN TANG, Master
Phone
（86+）18810941269
Email
1225530172@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaochun Liang, Doctor
Organizational Affiliation
Peking Union Medical College Hospital traditional Chinese medicine department
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital traditional Chinese medicine department
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Zhang, Doctor
Phone
（86+）13810387388
Email
qianqian0409@163.com
First Name & Middle Initial & Last Name & Degree
Zhen Tang, Master
Phone
（86+）18810941269
Email
1225530172@qq.com

12. IPD Sharing Statement

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

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