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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: YH14617; Drug: YH14617; Drug: YH14617; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yuhan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Drug: YH14617; 1mg once weekly; Drug: YH14617; 1.6mg once weekly; Drug: YH14617; 2mg once biweekly
Experimental: Group B	Drug: YH14617; 1mg once weekly; Drug: YH14617; 1.6mg once weekly; Drug: YH14617; 2mg once biweekly
Experimental: Group C	Drug: YH14617; 1mg once weekly; Drug: YH14617; 1.6mg once weekly; Drug: YH14617; 2mg once biweekly
Placebo Comparator: Group D	Drug: Placebo; Once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in HbA1c at week 12	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in body weight at week 12	Baseline, Week 12
Change from baseline in fasting plasma glucose at week 12	Baseline, Week 12
Change from baseline in 1,5-anhydroglucitol at week 12	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Collaborators: Peptron, Inc.
• Investigators: Principal Investigator: Dong-Seop Choi, MD, PhD., Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: January 5, 2012
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Estimate): February 18, 2015
• Last Update Submitted That Met QC Criteria: February 16, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Yuhan; Exenatide; YH14617
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: YH14617-201