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

This study has been completed.
Sponsor:
Collaborator:
Tasly Pharmaceuticals, Inc.
Information provided by:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01107171
First received: April 15, 2010
Last updated: April 20, 2010
Last verified: May 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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 Comparator: placebo
Tang-min Lin pills analogue
Drug: Placebo
Tang-min-Ling pills analogue 6g,tid,po
Other Name: 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 Name: 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 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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Tong Xiaolin, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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: 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
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014