Safety and Efficacy of YH14617 in Diabetes Mellitus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Peptron, Inc.
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01507038
First received: January 5, 2012
Last updated: August 26, 2014
Last verified: August 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: February 2015
Estimated Primary Completion Date: February 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507038

Locations
Korea, Republic of
Yuhan
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: August 26, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yuhan Corporation:
Diabetes Mellitus
YH14617
Exenatide
Yuhan

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

ClinicalTrials.gov processed this record on September 22, 2014