糖敏灵二期完成

midsmile

http://clinicaltrials.gov/ct2/show/study/NCT01107171?spons=%22Tasly+Pharmaceuticals%2C+Inc.%22&spons_ex=Y&rank=2

Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes
This study has been completed.
First Received: April 15, 2010 Last Updated: April 20, 2010 History of Changes
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator: Tasly Pharmaceuticals, Inc.

Information provided by: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01107171

Purpose
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.



Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Tang-min-ling pills low dosage
Drug: Tang-min-ling pills high dosage
Drug: Placebo
Phase II



Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Multi-center Randomized Controled and Double Blind Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes


Resource links provided by NLM:


Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus
MedlinePlus related topics: Diabetes
U.S. FDA Resources



Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:


Primary Outcome Measures:
Hemoglobin A1c (HbA1c) [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: Yes ]
The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison.




Secondary Outcome Measures:
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC) [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: Yes ]

symptoms score and Chinese syndrome [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: Yes ]

The rate of adverse events,the blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: Yes ]
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.



Enrollment: 210
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
placebo: Placebo Comparator
Tang-min Lin pills analogue
Intervention: Drug: Placebo Drug: Placebo
Tang-min-Ling pills analogue 6g,tid,po
Other Name: Tang-min-Ling pills analogue
Tang-min-ling pills high dosage: Experimental
Tang-min-ling pills, high dosage, 12g, tid po
Intervention: Drug: Tang-min-ling pills high dosage 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 Name: Tang min lin pills
Tang-min-ling pills low dosage: Experimental
low dosage group:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
Intervention: Drug: Tang-min-ling pills low dosage 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 Name: Tang min lin pill


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.

Eligibility


Ages Eligible for Study: 30 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107171


Locations
China
Jilin Hospital of Integrated Traditional and Western Medicine
Changchun, China, 132001
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, China, 130041
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, China

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

More Information

No publications provided

Responsible Party: Guang'anmen Hospital of China Academy of Chinese Medical Sciences ( Tong Xiaolin )
ClinicalTrials.gov Identifier: NCT01107171 History of Changes
Other Study ID Numbers: 2008002P2A02
Study First Received: April 15, 2010
Last Updated: April 20, 2010
Health Authority: China: State Food and Drug Administration

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Tang-min-ling pills;
overweight type 2 diabetes mellitus;
blood glucose
Traditional Chinese Medicine
Clinical Trial
Intervention Studies



Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases



ClinicalTrials.gov processed this record on March 17, 2011