Clinical trial NCT01507038: Safety and Efficacy of YH14617 in Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
YH14617
Exenatide
Yuhan
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
Collaborators: name: Peptron, Inc.
First posted: 2012-01-10
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in HbA1c at week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change from baseline in body weight at week 12
timeFrame: Baseline, Week 12
measure: Change from baseline in fasting plasma glucose at week 12
timeFrame: Baseline, Week 12
measure: Change from baseline in 1,5-anhydroglucitol at week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yuhan
Study officials:
affiliation: Korea University Anam Hospital
name: Dong-Seop Choi, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: