Safety and Efficacy of YH14617 in Diabetes Mellitus

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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. Study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation
• Collaborator: Peptron, Inc.

Criteria

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