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

NCT01107171 | Completed Phase 2 DMC

• 1 other identifier: 2008002P2A02
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Tang-min-ling pills;; overweight type 2 diabetes mellitus;; blood glucose; Traditional Chinese Medicine; Clinical Trial; Intervention Studies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  12 weeks after treatment

Study Arms (3)

placebo

PLACEBO COMPARATOR

Tang-min Lin pills analogue

Drug: Placebo

Tang-min-ling pills high dosage

EXPERIMENTAL

Tang-min-ling pills, high dosage, 12g, tid po

Drug: Tang-min-ling pills high dosage

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.

Drug: Tang-min-ling pills low dosage

Interventions

Tang-min-ling pills low dosage DRUG

low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.

Also known as: Tang min lin pill

Tang-min-ling pills low dosage

Tang-min-ling pills high dosage DRUG

high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.

Also known as: Tang min lin pills

Tang-min-ling pills high dosage

Placebo DRUG

Tang-min-Ling pills analogue 6g,tid,po

Also known as: Tang-min-Ling pills analogue

placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary type 2 diabetes mellitus
• BMI ≥ 24 kg•m-2
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Tasly Pharmaceuticals, Inc.: collaborator

Study Sites (6)

The Affiliated Hospital to Changchun University of Chinese Medicine

Changchun, 130041, China

Location

Jilin Hospital of Integrated Traditional and Western Medicine

Changchun, 132001, China

Location

Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine

Shenyang, China

Location

The Second Affiliated Hospital to Liaoning University of TCM

Shenyang, China

Location

First Teaching Hospital of Tianjin University of TCM

Tianjin, 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

• Xiaolin Tong, Ph.D

  Guang Anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 20, 2010
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 21, 2010

Record last verified: 2008-05

Locations

CN (6)