Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

Multi-center Randomized Controled and Double Blind Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes

Tang-min-ling pills are made by Chinese herbs extract, and data showed they had antidiabetic effects on the experimental rats and no obvious toxicity was found.This is a randomized, doubled blind, dose-paralleled-control multi-centre clinical trial to evaluate the efficacy and safety of Tang-min-ling pills in the treatment of type 2 diabetic patients and explore the optimal dosage of Tang-min-ling pills.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: Tang-min-ling pills high dosage; Drug: Tang-min-ling pills low dosage

Detailed Description

Two hundred and ten of overweight patients inflicted with primary diabetes mellitus who had stagnated heat of liver and stomach syndrome were recruited, which were randomly divided into 3 groups, and were given high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time)、placebo by 3 times every day for 12 weeks respectively. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、syndrome、symptoms、body mass index (BMI)、waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Changchun, China, 130041
    • The Affiliated Hospital To Changchun University of Chinese Medicine
  • Changchun, China, 132001
    • Jilin Hospital of Integrated Traditional and Western Medicine
  • Shanghai, China
    • Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine
  • Shenyang, China
    • The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine
  • Shenyang, China
    • The Second Affiliated Hospital to Liaoning University of TCM
  • Tianjin, China
    • First Teaching Hospital of Tianjin University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with primary type 2 diabetes mellitus
2. BMI ≥ 24 kg•m-2
3. 30-70 years old
4. HbA1c≥7.0%, and FPG>7.0 mmol/L, but <13.9 mmol/L or 2hPG>11.1 mmol/L
5. Informed consent has been signed
6. stagnated heat of liver and stomach syndrome according to TCM syndrome differentiation

Exclusion Criteria:

1. The patients accepted diabetic treatment for more than a month continuously
2. The patients were treated by drugs in 3 week before they were given test drugs
3. Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month
4. The contractive pressure >160 mmHg or diastolic pressure >100 mmHg
5. Pregnant, preparing for pregnancy or breast-feeding women
6. Mental patients
7. The patients who have serious heart, lung, liver, kidney and brain or other primary complications
8. Allergic persons
9. The patients who are attending other clinical trial
10. The patients who have serious diabetic complications
11. The patients who ever attended this clinical trial
12. Alcohol and / or psychoactive substances, drug abuse and dependency
13. The person maybe loss for some reason such as work or life condition according to the investigator's judgement
14. The lipid-lowering or antihypertensive drug dosage and category which the patients are taking couldn't be kept stable
15. The patients who are eating some drugs or health food which can affect the body weight

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Tang-min Lin pills analogue	Drug: Placebo; Tang-min-Ling pills analogue 6g,tid,po; Other Names: Tang-min-Ling pills analogue
Experimental: Tang-min-ling pills high dosage; Tang-min-ling pills, high dosage, 12g, tid po	Drug: Tang-min-ling pills high dosage; high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.; Other Names: Tang min lin pills
Experimental: Tang-min-ling pills low dosage; low dosage group:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.	Drug: Tang-min-ling pills low dosage; low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.; Other Names: Tang min lin pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c (HbA1c)	The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison.	12 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC)		12 weeks after treatment
symptoms score and Chinese syndrome		12 weeks after treatment
The rate of adverse events,the blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests	The number of participants with adverse events were recorded and compared. The blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and observe the safety.	12 weeks after treatment

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Tasly Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Xiaolin Tong, Ph.D, Guang Anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Estimate): April 21, 2010
• Last Update Submitted That Met QC Criteria: April 20, 2010
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Intervention Studies; Tang-min-ling pills;; overweight type 2 diabetes mellitus;; blood glucose; Traditional Chinese Medicine; Clinical Trial
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2008002P2A02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No