Safety and Efficacy of YH14617 in Diabetes Mellitus

NCT ID: NCT01507038

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-02-28

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

Group Type: EXPERIMENTAL

YH14617

Intervention Type: DRUG

1mg once weekly

Group B

Group Type: EXPERIMENTAL

YH14617

Intervention Type: DRUG

1.6mg once weekly

Group C

Group Type: EXPERIMENTAL

YH14617

Intervention Type: DRUG

2mg once biweekly

Group D

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Once weekly

Interventions

YH14617

1mg once weekly

Intervention Type: DRUG

YH14617

1.6mg once weekly

Intervention Type: DRUG

YH14617

2mg once biweekly

Intervention Type: DRUG

Placebo

Once weekly

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peptron, Inc.

INDUSTRY

Sponsor Role: collaborator

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dong-Seop Choi, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Yuhan

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YH14617-201

Identifier Type: -

Identifier Source: org_study_id