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Glycemic Variability of Combination Therapies in T2DM
A multicenter study to evaluate efficacy and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Empagliflozin/Metformin + Anagliptin |
|
| Active Comparator | Active Comparator | Metformin + Empagliflozin/Linagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin/Metformin | Drug | 5/500 mg, 5/1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Mean Amplitude of Glycemic Excursion (MAGE) from baseline to week 12 | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the percentage of time spent within the target glucose range (70-180 mg/dL) | Baseline to week 12 | |
| Change from baseline in mean blood glucose at 12 weeks | Baseline to week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saemi Kang | Contact | 82-2-840-6902 | kangsm@jwhealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Sung Rae Kim | The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Bucheon St. Mary's Hospital, Principal Investigator | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D008687 | Metformin |
| C583175 | anagliptin |
| D000069476 | Linagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011687 |
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randomized, open-label, active-controlled, parallel, phase IV
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| Anagliptin | Drug | 100 mg, for 12 weeks (PO, BID) |
|
| Metformin | Drug | 500 mg, 1000 mg (based on prior Metformin dose), for 12 weeks (PO, BID) |
|
| Empagliflozin/Linagliptin | Drug | 10/5 mg, for 12 weeks (PO, QD) |
|
| Change from baseline in HbA1c at 12 weeks |
| Baseline to week 12 |
| Change from baseline in FPG at 12 weeks | Baseline to week 12 |
| Change from baseline in HOMA-β at 12 weeks | HOMA- β: 20*fasting insulin/[(fasting plasma glucose*0.0555)-3.5] | Baseline to week 12 |
| Change from baseline in HOMA-IR at 12 weeks | HOMA-IR: fasting insulin*(fasting glucose*0.0555)/22.5 | Baseline to week 12 |
| D004700 | Endocrine System Diseases |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011799 | Quinazolines |