Safety and Efficacy of YH14617 in Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: YH14617
* Drug: YH14617
* Drug: YH14617
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Drug: YH14617<br>* 1mg once weekly<br>|
| Experimental: Group B<br> | Drug: YH14617<br>* 1.6mg once weekly<br>|
| Experimental: Group C<br> | Drug: YH14617<br>* 2mg once biweekly<br>|
| Placebo Comparator: Group D<br> | Drug: Placebo<br>* Once weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at week 12 |  | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body weight at week 12 |  | Baseline, Week 12 | 
| Change from baseline in fasting plasma glucose at week 12 |  | Baseline, Week 12 | 
| Change from baseline in 1,5-anhydroglucitol at week 12 |  | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, YH14617, Exenatide, Yuhan