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

January 5, 2012
August 26, 2014
December 2011
February 2015   (final data collection date for primary outcome measure)
Change from baseline in HbA1c at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01507038 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: YH14617
    1mg once weekly
  • Drug: YH14617
    1.6mg once weekly
  • Drug: YH14617
    2mg once biweekly
  • Drug: Placebo
    Once weekly
  • Experimental: Group A
    Intervention: Drug: YH14617
  • Experimental: Group B
    Intervention: Drug: YH14617
  • Experimental: Group C
    Intervention: Drug: YH14617
  • Placebo Comparator: Group D
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01507038
YH14617-201
Yes
Yuhan Corporation
Yuhan Corporation
Peptron, Inc.
Principal Investigator: Dong-Seop Choi, MD, PhD. Korea University Anam Hospital
Yuhan Corporation
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP