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A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise
This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise.
This is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD-6277 100mg tab | Experimental | Oral tablet |
|
| HD-6277 50mg tab | Experimental | Oral tablet |
|
| HD-6277 25mg tab | Experimental | Oral tablet |
|
| Placebo | Placebo Comparator | Oral tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD-6277 100mg | Drug | PO, QD |
| |
| HD-6277 50mg |
| Measure | Description | Time Frame |
|---|---|---|
| change in HbA1c at weeks 12 from baseline | change in HbA1c at weeks 12 from baseline | at weeks 12 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| change in HbA1c at weeks 6 from baseline | change in HbA1c at weeks 6 from baseline | at weeks 6 from baseline |
| percentage of subjects with HbA1c level below 7.0% at weeks 12 | percentage of subjects with HbA1c level below 7.0% at weeks 12 |
| Measure | Description | Time Frame |
|---|---|---|
| change in body weight at weeks 6 and 12 from baseline | change in body weight at weeks 6 and 12 from baseline | at weeks 6 and 12 from baseline |
| change in GA/HbA1c at weeks 6 and 12 from baseline | change in GA/HbA1c at weeks 6 and 12 from baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sin Gon Kim Korea University Anam Hospital, PhD | Contact | +82 1577-0083 | k50367@korea.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| Drug |
PO, QD |
|
| HD-6277 25mg | Drug | PO, QD |
|
| Placebo | Drug | PO, QD |
|
| at weeks 12 |
| percentage of subjects with HbA1c level below 6.5% at weeks 12 | percentage of subjects with HbA1c level below 6.5% at weeks 12 | at weeks 12 |
| change in Glycoalbumin at weeks 6 and 12 from baseline | change in Glycoalbumin at weeks 6 and 12 from baseline | at weeks 6 and 12 from baseline |
| at weeks 6 and 12 from baseline |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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