Type 2 DiabetesPhase 2/3NCT02752880

YH1 in Poorly Controlled Type 2 Diabetes

A Phase 2/3 study testing YH1 group in people with Type 2 Diabetes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: YH1 group
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteTaiwan
Study dates: Jun 2016to Feb 2018
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

20-75 years of age;
Diagnosed as type 2 diabetics based on World Health Organization criteria [1];
Body mass index (BMI) ≥ 23 kg/m2;
Have been treated with ≥ 3 kinds of oral hypoglycemic agents (OHAs) with persistent (> 6 months) high HbA1c (≥ 7.0 %).

Who cannot join

Type 1 diabetes, gestational diabetes, or other specific types of diabetes;
Have received insulin therapy in the past three months;
Have serious gastrointestinal (GI) tract diseases, such as peptic ulcers or GI tract bleeding;
Experience stressful situations, including diabetic ketoacidosis, nonketotic hyperosmolar diabetic coma, severe infection, or surgery in the previous one month;
Suffer from hepatic insufficiency with alanine aminotransferase (ALT) 2 times the upper limit of normal or renal insufficiency with estimated glomerular filtration rate (eGFR) < 60;
Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg);

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Mental illness, abused or addicted to alcohol, psychoactive substances or other drugs;
Pregnant, lactating, or plan to become pregnant;
Hemoglobin disease or chronic anemia;
Have underlying conditions that could lead to poor compliance;
History of cerebrovascular disease or myocardial infarction;
Have undergone Chinese medicine treatment in the past two weeks.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Study site
Taoyuan

Other trials in Taiwan

About this study

Official title: The Efficacy and Safety of Concentrated Herbal Extract Granules, YH1, as an Add-On Medication in Poorly Controlled Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

Type 2 diabetes mellitus is a chronic metabolic disease that seriously affects patients worldwide, and it is always among the top 10 causes of death in Taiwan. To date, still many patients who take more than three kinds of oral hypoglycemic agents could not effectively control their glycohemoglobin levels in clinics. Hypoglycemia as well as weight gain are common side effect with insulin therapy, and many patients in Taiwan are not willing to receive insulin injection. It is common for diabetic patients treated with Chinese herbal medicine in China currently, and some therapeutic effects have been published in international journals. In this study, we will evaluate whether Chinese herbal medicine, YH1, enhances the glycemic control and is safe as add-on medication in poorly controlled type 2 diabetes patients.

A total of 46 poorly controlled type 2 diabetes patients with glycohemoglobin ≥ 7% from Endocrinology and Metabolism clinics or Internal Chinese Medicine clinics will be enrolled in this randomized double-blind placebo-controlled trial. Subjects will be randomly assigned to receive either YH1 (6 g) or the placebo three times per day for 12 consecutive weeks. All subjects in both groups will also continuously receive their oral hypoglycemic agents without any dose or medicine change. During this 12-week period, the glycohemoglobin, fasting plasma glucose, 2h postprandial glucose, waist circumference, body weight, and body mass index will be assessed. In addition, insulin resistance, β -cell function, lipid profile, liver and renal function will also be evaluated. Independent statisticians will perform the data analysis at the end of the trial.

Read the detailed description

The YH1 in one batch number was used, manufactured by Sun Ten Pharmaceutical Co., LTD., a renowned GMP manufacturer of concentrated herbal extract granules conforming to international standards. The YH1 was prepared in small granules, including concentrated herbal extract granules of Rhizoma Coptidis (50%) and SLBZS (50%). Both medicines have already been approved by the Ministry of Health and Welfare in Taiwan as ethical drugs. YH1 granules were packed in aluminum foil packages. The placebo was also prepared as granules by Sun Ten Pharmaceutical Co., LTD., and the packaging of the placebo was identical to that of YH1. The chemical composition of YH1 was analyzed and profiled by using a high performance liquid chromatography (HPLC) with photodiode array (PDA) detection. Fourteen components, allantoin, atractylenolide III, berberine, coptisine, ginsenoside Rb1, ginsenoside Re, ginsenoside Rg1, glycyrrhizin, liquiritin, pachymic acid, palmatine, platycodin D, magnoflorin and quercitrin, were simultaneously used in the qualitative analysis under the developed HPLC-PDA method. As for the quantitative detection, each gram of YH1 contained 20.05 mg berberine.

Conditions: Type 2 Diabetes
Being tested: YH1 group, placebo group
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.

YH1 groupDrug
Also called Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San
Participants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.
placebo groupDrug
Participants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.

Study groups in NCT02752880
Study group	Role	What they receive
YH1 group	Experimental	YH1 with one batch number was manufactured by Sun Ten Pharmaceutical Co., Ltd., a renowned manufacturer of concentrated herbal extract granules conforming to the standards of good manufacturing practices (GMP) in New Taipei City, Taiwan. YH1 contains Rhizoma Coptidis (50 %) and Shen-Ling-Bai-Zhu-San (SLBZS) (50 %). SLBZS consists of Radix Ginseng, Poria, Rhizoma Atractylodis macrocephalae, Semen Lablab album, Rhizoma Dioscoreae, Embryo Nelumbinis, Radix Platycodonis, Semen Coicis, Fructus Amomi, Fructus Jujubae, and Radix Glycyrrhizae at a 3:3:3:2.3:3:1.5:1.5:1.5:1.5:1.5:3 ratio. Subjects in the YH1 group orally ingested two packages of granules (3 g/package) three times daily with warm water after a meal for 12 consecutive weeks. Receives: Drug: YH1 group
placebo group	Placebo comparator	The placebo was also prepared as granules by Sun Ten Pharmaceutical Co., Ltd., and the packaging of the placebo was identical to that of YH1. Subjects in the placebo group orally ingested two packages of granules (3 g/package) three times daily with warm water after a meal for 12 consecutive weeks. Receives: Drug: placebo group

What is being measured

The primary outcome is the main question the study is designed to answer.

The Percentage Change in HbA1c Level From Baseline to 12 Weeks
The primary efﬁcacy endpoint was the percentage change in HbA1c levels from baseline to 12 weeks. The HbA1c level was measured by HPLC in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.
Measured: 12 weeks

Secondary outcomes (1)

The Percentage Change in 2hPG From Baseline to Week 12
The secondary efﬁcacy endpoint was the percentage change in 2hPG level from baseline to 12 weeks by using enzymatic method in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2016Feb 2018

First posted27 Apr 2016 (estimated)
Study startJun 2016
Primary completionFeb 2018
Study completionFeb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02752880
Sponsor's protocol ID: 104-7934A3,105-7009C,106-0917C
Status last verified: Mar 2016
First submitted: 26 Apr 2016
Last updated: 22 Jul 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Concentrated Herbal Extract Granules, YH1, as an Add-On Medication in Poorly Controlled Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial
ClinicalTrials.gov ID: NCT02752880
Acronym / sponsor ID: 104-7934A3,105-7009C,106-0917C
Conditions: Type 2 Diabetes
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: Jun 2016 (actual)
Primary completion: Feb 2018 (actual)
Study completion: Feb 2018 (actual)
First posted: 27 Apr 2016 (estimated)
Results: Posted 22 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
YH1 group	Experimental	Drug: YH1 groupYH1 with one batch number was manufactured by Sun Ten Pharmaceutical Co., Ltd., a renowned manufacturer of concentrated herbal extract granules conforming to the standards of good manufacturing practices (GMP) in New Taipei City, Taiwan. YH1 contains Rhizoma Coptidis (50 %) and Shen-Ling-Bai-Zhu-San (SLBZS) (50 %). SLBZS consists of Radix Ginseng, Poria, Rhizoma Atractylodis macrocephalae, Semen Lablab album, Rhizoma Dioscoreae, Embryo Nelumbinis, Radix Platycodonis, Semen Coicis, Fructus Amomi, Fructus Jujubae, and Radix Glycyrrhizae at a 3:3:3:2.3:3:1.5:1.5:1.5:1.5:1.5:3 ratio. Subjects in the YH1 group orally ingested two packages of granules (3 g/package) three times daily with warm water after a meal for 12 consecutive weeks.
placebo group	Placebo comparator	Drug: placebo groupThe placebo was also prepared as granules by Sun Ten Pharmaceutical Co., Ltd., and the packaging of the placebo was identical to that of YH1. Subjects in the placebo group orally ingested two packages of granules (3 g/package) three times daily with warm water after a meal for 12 consecutive weeks.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

20-75 years of age;
Diagnosed as type 2 diabetics based on World Health Organization criteria [1];
Body mass index (BMI) ≥ 23 kg/m2;
Have been treated with ≥ 3 kinds of oral hypoglycemic agents (OHAs) with persistent (> 6 months) high HbA1c (≥ 7.0 %).

Key exclusion criteria (12 listed)

Type 1 diabetes, gestational diabetes, or other specific types of diabetes;
Have received insulin therapy in the past three months;
Have serious gastrointestinal (GI) tract diseases, such as peptic ulcers or GI tract bleeding;
Experience stressful situations, including diabetic ketoacidosis, nonketotic hyperosmolar diabetic coma, severe infection, or surgery in the previous one month;
Suffer from hepatic insufficiency with alanine aminotransferase (ALT) 2 times the upper limit of normal or renal insufficiency with estimated glomerular filtration rate (eGFR) < 60;

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
YH1 groupAlso: Rhizoma Coptidis and Shen-Ling-Bai-Zhu-SanParticipants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.	Drug	YH1 group
placebo groupParticipants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.	Drug	placebo group

Primary outcome

The Percentage Change in HbA1c Level From Baseline to 12 Weeks
Time frame: 12 weeks
The primary efﬁcacy endpoint was the percentage change in HbA1c levels from baseline to 12 weeks. The HbA1c level was measured by HPLC in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.

1 secondary outcome

The Percentage Change in 2hPG From Baseline to Week 12
Time frame: 12 weeks

Results and safety

Results posted to the registry on 22 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
YH1 Three Times Per Day for 12 Consecutive Weeks	23	21
Placebo	23	20

Primary outcome: The Percentage Change in HbA1c Level From Baseline to 12 Weeks

Time frame: 12 weeks. Median (Full Range). Unit: percentage change

Measure	YH1 Group n = 21	Placebo Group n = 20
Value	-11.1 (-30.2 to 14.1)	0.0 (-20.4 to 7.3)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
YH1 Group	0 of 23 (0%)	12 of 23 (52.2%)	0 of 23
Placebo Group	0 of 23 (0%)	13 of 23 (56.5%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Yueh-Hsiang Huang, MD principal investigator

Chang Gung Memorial Hospital, Taoyuan, Taiwan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing YH1 group in people with Type 2 Diabetes, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 4 inclusion and 12 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Percentage Change in HbA1c Level From Baseline to 12 Weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02752880.

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 22 Jul 2019.