Type 2 DiabetesPhase 3NCT01087242
Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus
A Phase 3 study testing Tang-min Lin pill in people with Type 2 Diabetes, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Tang-min Lin pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 4 sitesChina
- Study dates
- May 2009to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- usually change the working environment,unstable live environment,etc.which will complied the inclusion
- unstable dose or type of anti-hypertension drug
- taking the drug or health food which will change the body weight
Trial locations and contacts
4 sites in 1 country.
China4 sites
TCM school of Jiang Su province
Nanjing, Jiangsu, 210029
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, 116600
Tian Jin traditional chinese medicine university
Tianjin, Tianjin Municipality, 300193
About this study
Official title: Randomized，Double-blind，Dose Parallel Controlled, Multicentre Clinical Trail of Tang-min-Ling Pills and Placebo in Diabetes Mellitus(Liver-stomach Heat Retention Syndrome) (Phase Ⅲ)
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.
Read the detailed description
Type 2 diabetes mellitus combined liver-stomach heat retension syndrome were recruited, which were divided into 3 groups .The patients were randomly taken with 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Tang-min Lin pill
- Keywords
- Tang-min Lin pills, type 2 diabetes, liver and stomach heat retention, Evaluate the safety and efficacy of Tang-min Lin pills
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tang-min Lin pillDrug
Tang-min Lin pill 6g,tid,treat 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| controlled group | Placebo comparator | Tang-min Lin analogue 6g,tid,po Receives: Drug: Tang-min Lin pill |
| Tang-min Lin pill | Experimental | Tang-min Lin pills 6g,tid,po Receives: Drug: Tang-min Lin pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycosylated hemoglobin
Measured: 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
Measured: baseline and 12 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine, Liaoning University of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Beijing Hospital, Tianjin Tasly Pharmaceutical Co., Ltd
- Investigators
- Wu S Tao, pro., Principal investigator, Tian Jin university of tradtional chinese medicineLian F Mei, doctor, Study chair, Guang'anmen Hospital of China Academy of Chinese Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087242
- Sponsor's protocol ID
- 2008L00307
- Status last verified
- May 2009
- First submitted
- 9 Mar 2010
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized，Double-blind，Dose Parallel Controlled, Multicentre Clinical Trail of Tang-min-Ling Pills and Placebo in Diabetes Mellitus(Liver-stomach Heat Retention Syndrome) (Phase Ⅲ)
- ClinicalTrials.gov ID
- NCT01087242
- Acronym / sponsor ID
- 2008L00307
- Conditions
- Type 2 Diabetes
- Keywords
- Tang-min Lin pills, type 2 diabetes, liver and stomach heat retention, Evaluate the safety and efficacy of Tang-min Lin pills
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine, Liaoning University of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Beijing Hospital, Tianjin Tasly Pharmaceutical Co., Ltd
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Type 2 diabetes mellitus combined liver-stomach heat retension syndrome were recruited, which were divided into 3 groups .The patients were randomly taken with 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controlled group | Placebo comparator | Drug: Tang-min Lin pillTang-min Lin analogue 6g,tid,po |
| Tang-min Lin pill | Experimental | Drug: Tang-min Lin pillTang-min Lin pills 6g,tid,po |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tang-min Lin pillTang-min Lin pill 6g,tid,treat 12 weeks. | Drug | Tang-min Lin pill, controlled group |
Primary outcome
glycosylated hemoglobin
Time frame: 0 and 12weeks after treatment
1 secondary outcome
fasting blood glucose,2-hour postprandial blood glucose,true insulin,TG,TG、LCL-C、HDL-C、BMI,waistline, hipline,TCM syndrome and sign
Time frame: baseline and 12 week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu S Tao, pro. principal investigator
Tian Jin university of tradtional chinese medicine
Lian F Mei, doctor study chair
Guang'anmen Hospital of China Academy of Chinese Medical
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tang-min Lin pill in people with Type 2 Diabetes, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycosylated hemoglobin (time frame: 0 and 12weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2010.