Status:
COMPLETED
Safety and Efficacy of YH14617 in Diabetes Mellitus
Lead Sponsor:
Yuhan Corporation
Collaborating Sponsors:
Peptron, Inc.
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief 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 optima...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01507038
Start Date
December 1 2011
End Date
February 1 2015
Last Update
February 18 2015
Active Locations (1)
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1
Yuhan
Seoul, South Korea