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

NCT02617732 | Unknown

• 1 other identifier: PUMCH-TCM-TQGV-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

glucose variability; continuous glucose mornitoring system; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in serum lipid and lipoprotein at 12 weeks.

  12 weeks

• Change from baseline in hemoglobin A1c(HbA1c) at 12 weeks

  12 weeks

• Liver Function Examination

  4 weeks

• Renal Function Examination

  4 weeks

Study Arms (2)

Tianqi capsule

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Tianqi capsule DRUG

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

Also known as: Tianqi Jiangtang Jiaonang, Z20063799

Tianqi capsule

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• kg/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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital traditional Chinese medicine department

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Xiaochun Liang, Doctor

  Peking Union Medical College Hospital traditional Chinese medicine department

  STUDY DIRECTOR

Central Study Contacts

Qian Zhang, Doctor

CONTACT

（86+）13810387388; qianqian0409@163.com

ZHEN TANG, Master

CONTACT

（86+）18810941269; 1225530172@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: December 1, 2015

Record last verified: 2015-11

Locations

CN (1)