NCT01087242

Brief Summary

This is a randomized, doubled blind, dose-paralleled control, multi-centre clinical trail,to evaluate the efficacy of Tang-min-ling pills in the treatment of type 2 diabetes mellitus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 16, 2010

Status Verified

May 1, 2009

Enrollment Period

7 months

First QC Date

March 9, 2010

Last Update Submit

March 15, 2010

Conditions

Type 2 Diabetes

Keywords

Tang-min Lin pillstype 2 diabetesliver and stomach heat retentionEvaluate the safety and efficacy of Tang-min Lin pills

Outcome Measures

Primary Outcomes (1)

  • glycosylated hemoglobin

    0 and 12weeks after treatment

Secondary Outcomes (1)

  • fasting blood glucose,2-hour postprandial blood glucose,true insulin,TG,TG、LCL-C、HDL-C、BMI,waistline, hipline,TCM syndrome and sign

    baseline and 12 week after treatment

Study Arms (2)

controlled group

PLACEBO COMPARATOR

Tang-min Lin analogue 6g,tid,po

Drug: Tang-min Lin pill

Tang-min Lin pill

EXPERIMENTAL

Tang-min Lin pills 6g,tid,po

Drug: Tang-min Lin pill

Interventions

Tang-min Lin pillDRUG

Tang-min Lin pill 6g,tid,treat 12 weeks.

Tang-min Lin pillcontrolled group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • initial treatment type 2 diabetic patient
  • liver-stomach heat retention syndrome
  • BMI ≥24kg/m2
  • aged 30-65 years
  • after screening stage(lifestyle intervention),Hba1C≥7.0%,FPG7.0-13.3mmol/L or PG2h\>11.1mmol/L;
  • voluntary signs the informed consent

You may not qualify if:

  • have used anti-diabetes drug before more than 1 month
  • used drug to control the blood sugar with 3 weeks
  • diabetic ketosis,keto-acidosis,serious infection or trauma,major surgery within 1 month
  • liver or kidney insufficiency,lung insufficiency,heart failure,acute myocardial infarction or other serious primary disease
  • SBP/DBP \>160mmHg/100 mmHg
  • serious chronic diabetic complication
  • chronic stomach-intestine disease,bad condition of the whole body
  • pregnancy,preparing to pregnant,or breast-feed stage women
  • allergic to TCM component
  • mental disease
  • allergic habitus
  • attending to other clinical test
  • attended this test before
  • bibulosity and/or mental active drug,drug abuse or depend
  • unstable dose or type of anti-hypertension drug
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

TCM school of Jiang Su province

Nanjing, Jiangsu, 210029, China

Location

Liaoning University of Traditional Chinese Medicine

Shenyang, Liaoning, 116600, China

Location

Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Tian Jin traditional chinese medicine university

Tianjin, Tianjin Municipality, 300193, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Wu S Tao, pro.

    Tian Jin university of tradtional chinese medicine

    PRINCIPAL INVESTIGATOR

  • Lian F Mei, doctor

    Guang'anmen Hospital of China Academy of Chinese Medical

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 16, 2010

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

March 16, 2010

Record last verified: 2009-05

Locations

CN(4)