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| Name | Class |
|---|---|
| Peptron, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
| |
| Group D | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH14617 | Drug | 1mg once weekly |
| |
| YH14617 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c at week 12 | Baseline, Week 12 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Seop Choi, MD, PhD. | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuhan | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Drug |
1.6mg once weekly |
|
| YH14617 | Drug | 2mg once biweekly |
|
| Placebo | Drug | Once weekly |
|
| Baseline, Week 12 |