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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107171
• Other study ID #: 2008002P2A02
• Status: Completed
• Phase: Phase 2
• First received: April 15, 2010
• Last updated: April 20, 2010
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2008
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Tang-min-ling pills low dosage
low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
• Tang-min-ling pills high dosage
high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
• Placebo
Tang-min-Ling pills analogue 6g,tid,po

Locations

Country	Name	City	State
China	Jilin Hospital of Integrated Traditional and Western Medicine	Changchun
China	The Affiliated Hospital to Changchun University of Chinese Medicine	Changchun
China	Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine	Shanghai
China	The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine	Shenyang
China	The Second Affiliated Hospital to Liaoning University of TCM	Shenyang
China	First Teaching Hospital of Tianjin University of TCM	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Tasly Pharmaceuticals, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Fasting plasma glucose (FPG)?postprandial 2 hours plasma glucose(2hPG)?body mass index (BMI)?waist circumference (WC)		12 weeks after treatment	Yes
Secondary	symptoms score and Chinese syndrome		12 weeks after treatment	Yes
Secondary	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	Yes