Safety and Efficacy of YH14617 in Diabetes Mellitus

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507038
• Other study ID #: YH14617-201
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2012
• Last updated: February 16, 2015
• Start date: December 2011
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• YH14617
1mg once weekly
• YH14617
1.6mg once weekly
• YH14617
2mg once biweekly
• Placebo
Once weekly

Locations

Country	Name	City	State
Korea, Republic of	Yuhan	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yuhan Corporation	Peptron, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c at week 12		Baseline, Week 12	No
Secondary	Change from baseline in body weight at week 12		Baseline, Week 12	No
Secondary	Change from baseline in fasting plasma glucose at week 12		Baseline, Week 12	No
Secondary	Change from baseline in 1,5-anhydroglucitol at week 12		Baseline, Week 12	No