Diabetes Mellitus, Type 2Phase 2NCT01107171
Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes
A Phase 2 study testing Tang-min-ling pills low dosage and Tang-min-ling pills high dosage in people with Diabetes Mellitus, Type 2, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 6 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Tang-min-ling pills low dosage and Tang-min-ling pills high dosage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 6 sitesChina
- Study dates
- May 2008to Dec 2008
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
The Affiliated Hospital to Changchun University of Chinese Medicine
Changchun, 130041
Jilin Hospital of Integrated Traditional and Western Medicine
Changchun, 132001
Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine
Shanghai
The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine
Shenyang
The Second Affiliated Hospital to Liaoning University of TCM
Shenyang
First Teaching Hospital of Tianjin University of TCM
Tianjin
About this study
Official title: Multi-center Randomized Controled and Double Blind Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Tang-min-ling pills low dosage, Tang-min-ling pills high dosage, Placebo
- Keywords
- Tang-min-ling pills;, overweight type 2 diabetes mellitus;, blood glucose, Traditional Chinese Medicine, Clinical Trial, Intervention Studies
- 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-ling pills low dosageDrug
Also called Tang min lin pill
low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
Tang-min-ling pills high dosageDrug
Also called Tang min lin pills
high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
PlaceboDrug
Also called Tang-min-Ling pills analogue
Tang-min-Ling pills analogue 6g,tid,po
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Tang-min Lin pills analogue Receives: Drug: Placebo |
| Tang-min-ling pills high dosage | Experimental | Tang-min-ling pills, high dosage, 12g, tid po Receives: 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. Receives: Drug: Tang-min-ling pills low dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after treatment
Secondary outcomes (3)
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC)
Measured: 12 weeks after treatment
symptoms score and Chinese syndrome
Measured: 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
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.
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tasly Pharmaceuticals, Inc.
- Investigators
- Xiaolin Tong, Ph.D, Principal investigator, Guang Anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107171
- Sponsor's protocol ID
- 2008002P2A02
- Status last verified
- May 2008
- First submitted
- 15 Apr 2010
- Last updated
- 21 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Randomized Controled and Double Blind Trial of Tang-min-ling Pills in the Treatment of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01107171
- Acronym / sponsor ID
- 2008002P2A02
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Tang-min-ling pills;, overweight type 2 diabetes mellitus;, blood glucose, Traditional Chinese Medicine, Clinical Trial, Intervention Studies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Tasly Pharmaceuticals, Inc.
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Apr 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboTang-min Lin pills analogue |
| Tang-min-ling pills high dosage | Experimental | Drug: Tang-min-ling pills high dosageTang-min-ling pills, high dosage, 12g, tid po |
| Tang-min-ling pills low dosage | Experimental | Drug: Tang-min-ling pills low dosagelow dosage group:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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-ling pills low dosageAlso: Tang min lin pilllow dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks. | Drug | Tang-min-ling pills low dosage |
| Tang-min-ling pills high dosageAlso: Tang min lin pillshigh dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks. | Drug | Tang-min-ling pills high dosage |
| PlaceboAlso: Tang-min-Ling pills analogueTang-min-Ling pills analogue 6g,tid,po | Drug | placebo |
Primary outcome
Hemoglobin A1c (HbA1c)
Time frame: 12 weeks after treatment
The HbA1c was measured and analyzed twice, one is before the treatment and the other is 12 weeks aftertreatment to make a self comparison.
3 secondary outcomes
Fasting plasma glucose (FPG)、postprandial 2 hours plasma glucose(2hPG)、body mass index (BMI)、waist circumference (WC)
Time frame: 12 weeks after treatment
symptoms score and Chinese syndrome
Time frame: 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
Time frame: 12 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 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.
Xiaolin Tong, Ph.D principal investigator
Guang Anmen Hospital of China Academy of Chinese Medical Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tang-min-ling pills low dosage and Tang-min-ling pills high dosage in people with Diabetes Mellitus, Type 2, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 6 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 15 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: finished, as of the sponsor's last update on 21 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hemoglobin A1c (HbA1c) (time frame: 12 weeks 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 21 Apr 2010.