Safety and Efficacy of YH14617 in Diabetes Mellitus

This study is currently recruiting participants.
Verified April 2014 by Yuhan Corporation
Sponsor:
Collaborator:
Peptron, Inc.
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01507038
First received: January 5, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: YH14617
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Change from baseline in HbA1c at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in body weight at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in 1,5-anhydroglucitol at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: YH14617
1mg once weekly
Experimental: Group B Drug: YH14617
1.6mg once weekly
Experimental: Group C Drug: YH14617
2mg once biweekly
Placebo Comparator: Group D Drug: Placebo
Once weekly

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507038

Contacts
Contact: Dong-Seop Choi, MD, PhD. +82-2953-9355 cdongs@kumc.or.kr

Locations
Korea, Republic of
Yuhan Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Yuhan Corporation
Peptron, Inc.
Investigators
Principal Investigator: Dong-Seop Choi, MD, PhD. Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01507038     History of Changes
Other Study ID Numbers: YH14617-201
Study First Received: January 5, 2012
Last Updated: April 14, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yuhan Corporation:
Diabetes Mellitus
YH14617
Exenatide
Yuhan

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014