Diabetes MellitusPhase 2NCT01507038
Safety and Efficacy of YH14617 in Diabetes Mellitus
A Phase 2 study testing YH14617 in people with Diabetes Mellitus, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617 after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to investigate the optimal recommended dosage. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- YH14617
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Feb 2015
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed a written informed consent voluntary, prior to the any procedure
- Volunteers of aged between 20 years to 75 years
- Have been diagnosed with type 2 diabetes at least 3 months prior to study
- Have a body mass index (BMI) of > 23kg/m2 and have a history of stable body weight during 3 months prior to the first administration (not varying by > 5% in weight)
- Have been treated with stable dose regimen of Metformin > 1500mg/day or maximum tolerant dose for at least 3 months prior to the first administration
- Have an HbA1c between 7% and 10% inclusive
Who cannot join
- Have been treated with insulin, sulfonylurea, thiazolidinedione class hypoglycemic drugs, exenatide or other GLP-1 receptor agonist, DPP4-inhibitor, glucocorticoid and drugs that promote weight loss within 3 months prior to the first administration
- Have acute disease, other untreated disease or diabetic complications that needs additional treatment
- Have severe renal disorder(serum creatinine concentration > 1.5 times of normal upper limit) or liver disorder(liver enzyme > 2 times of normal upper limit)
- Have blood pressure > 160/100mmHg
- Have been hospitalized due to cardiac disorder(angina, cardiac infarction, heart failure and etc.) within 1 year prior to the first administration
- Have history of critical disease within 1 year prior to the first administration
Show all 13Show fewer
- Have untreated malignant tumor or have history of significant malignant tumor within 5 years prior to the first administration
- Have fasting plasma glucose(FPG) > 250mg/dl or have random glucose level > 350mg/dl
- Have more than 1 history of severe hypoglycemia that needed others help within 3 months prior to the first administration
- Have a known allergy or hypersensitivity to drugs
- Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
- Participated in any other clinical trials within 30 days prior to the first administration
- Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons other than above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Trial to Investigate the Efficacy, Safety and Pharmacokinetics of YH14617 After Once Weekly or Biweekly Administration in Patients With Type 2 Diabetes Mellitus
The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617 after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.
- Conditions
- Diabetes Mellitus
- Being tested
- YH14617, Placebo
- Keywords
- Diabetes Mellitus, YH14617, Exenatide, Yuhan
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH14617Drug
1mg once weekly
YH14617Drug
1.6mg once weekly
YH14617Drug
2mg once biweekly
PlaceboDrug
Once weekly
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: YH14617 |
| Group B | Experimental | Not described Receives: Drug: YH14617 |
| Group C | Experimental | Not described Receives: Drug: YH14617 |
| Group D | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c at week 12
Measured: Baseline, Week 12
Secondary outcomes (3)
Change from baseline in body weight at week 12
Measured: Baseline, Week 12
Change from baseline in fasting plasma glucose at week 12
Measured: Baseline, Week 12
Change from baseline in 1,5-anhydroglucitol at week 12
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peptron, Inc.
- Responsible party
- Sponsor
- Investigators
- Dong-Seop Choi, MD, PhD., Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507038
- Sponsor's protocol ID
- YH14617-201
- Status last verified
- Feb 2015
- First submitted
- 5 Jan 2012
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Investigate the Efficacy, Safety and Pharmacokinetics of YH14617 After Once Weekly or Biweekly Administration in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01507038
- Acronym / sponsor ID
- YH14617-201
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, YH14617, Exenatide, Yuhan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Peptron, Inc.
- Study start
- Dec 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Jan 2012 (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.
The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617 after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: YH14617 |
| Group B | Experimental | Drug: YH14617 |
| Group C | Experimental | Drug: YH14617 |
| Group D | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have signed a written informed consent voluntary, prior to the any procedure
- Volunteers of aged between 20 years to 75 years
- Have been diagnosed with type 2 diabetes at least 3 months prior to study
- Have a body mass index (BMI) of > 23kg/m2 and have a history of stable body weight during 3 months prior to the first administration (not varying by > 5% in weight)
- Have been treated with stable dose regimen of Metformin > 1500mg/day or maximum tolerant dose for at least 3 months prior to the first administration
Key exclusion criteria (13 listed)
- Have been treated with insulin, sulfonylurea, thiazolidinedione class hypoglycemic drugs, exenatide or other GLP-1 receptor agonist, DPP4-inhibitor, glucocorticoid and drugs that promote weight loss within 3 months prior to the first administration
- Have acute disease, other untreated disease or diabetic complications that needs additional treatment
- Have severe renal disorder(serum creatinine concentration > 1.5 times of normal upper limit) or liver disorder(liver enzyme > 2 times of normal upper limit)
- Have blood pressure > 160/100mmHg
- Have been hospitalized due to cardiac disorder(angina, cardiac infarction, heart failure and etc.) within 1 year prior to the first administration
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 |
|---|---|---|
| YH146171mg once weekly | Drug | Group A |
| YH146171.6mg once weekly | Drug | Group B |
| YH146172mg once biweekly | Drug | Group C |
| PlaceboOnce weekly | Drug | Group D |
Primary outcome
Change from baseline in HbA1c at week 12
Time frame: Baseline, Week 12
3 secondary outcomes
Change from baseline in body weight at week 12
Time frame: Baseline, Week 12
Change from baseline in fasting plasma glucose at week 12
Time frame: Baseline, Week 12
Change from baseline in 1,5-anhydroglucitol at week 12
Time frame: Baseline, Week 12
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 18 Feb 2015.
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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.
Dong-Seop Choi, MD, PhD. principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YH14617 in people with Diabetes Mellitus, run by Yuhan Corporation at 1 site in South Korea.
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 13 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 18 Feb 2015. 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 South Korea. 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?
Change from baseline in HbA1c at week 12 (time frame: Baseline, Week 12). 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 18 Feb 2015.