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CompletedPhase 2

Safety and Efficacy of YH14617 in Diabetes Mellitus

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

Lead sponsor

Yuhan Corporation

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

84

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI ≥23HbA1c 7-10%

Primary endpoint

HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01507038
Org study IDYH14617-201

Timeline

Milestones

Study first posted2012-01-10estimated
Last update posted2015-02-18estimated
Study start2011-12 (month precision)
Primary completion2015-01actual (month precision)
Study completion2015-02actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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

Exclusion criteria

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
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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
3
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from baseline in body weight at week 12

Time frame:Baseline, Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Change from baseline in HbA1c at week 12

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in fasting plasma glucose at week 12

Time frame:Baseline, Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in 1,5-anhydroglucitol at week 12

Time frame:Baseline, Week 12

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.