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| ID | Type | Description | Link |
|---|---|---|---|
| NPI-1831468511 | Registry Identifier | HHS, Health Care Provider Individual | |
| NPI-1023387701 | Registry Identifier | HHS, Health Care Provider Organization | |
| FWA00015357 | Registry Identifier | HHS, Human Protections Administrator | |
| IORG0007849 | Registry Identifier | HHS, IORG | |
| IRB00009424 | Registry Identifier | HHS, IRB | |
| ANDA219975 | Registry Identifier | FDA, ANDA | |
| ANDA220011 | Registry Identifier | FDA, ANDA |
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| Name | Class |
|---|---|
| UnitedHealthcare | OTHER |
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Use Dapagliflozin 10 mg, Saxagliptin 5 mg, Metformin 500 mg treat type 2 diabetes patients with controlled cancers
The usual approach group, Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral, 300 double blind random group type 2 diabetes patients with controlled cancers
The study approach group, China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral, 300 double blind random group type 2 diabetes patients with controlled cancers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix | Experimental | Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription |
|
| China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix | Experimental | China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Farxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes | Drug | Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription Treat type 2 diabetes patients with controlled cancers |
| Measure | Description | Time Frame |
|---|---|---|
| Detect Hemoglobin A1c (HbA1c) | Draw blood Detect Hemoglobin A1c (HbA1c) | Duration up to 90 days |
| Detect fasting blood glucose (FBG) | Draw blood Detect fasting blood glucose (FBG) | Duration up to 90 days |
| Detect 2-hour postprandial blood glucose (2 hPBG) | Draw blood Detect 2-hour postprandial blood glucose (2 hPBG) | Duration up to 90 days |
| Detect fasting insulin (FINS) | Draw blood Detect fasting insulin (FINS) | Duration up to 90 days |
| Detect 2-hour postprandial insulin (2 hPINS) | Draw blood Detect 2-hour postprandial insulin (2 hPINS) | Duration up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HAN ID XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Study Chair |
| HAN ID XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Study Director |
| HAN ID XU, MD/PhD/FAPCR | Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701 | Rockville | Maryland | 20853 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31852646 | Result | Xu Y, Wu P, Wen W, Chen H. [Short-term intensive combined therapy with metformin, sagliptin and dapagliflozin for newly diagnosed type 2 diabetes: efficacy, weight control and safety]. Nan Fang Yi Ke Da Xue Xue Bao. 2019 Nov 30;39(11):1305-1311. doi: 10.12122/j.issn.1673-4254.2019.11.07. Chinese. |
| Label | URL |
|---|---|
| FWA \< 00015357 \> \< Medicine Invention Design Incorporation \> | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2025 | Jul 6, 2025 |
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No-placebo and random and double blind
|
| China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes | Drug | China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription Treat type 2 diabetes patients with controlled cancers |
|
|
| IRB \< 00009424 \> \< Medicine Invention Design Incorporation \> | View source |
| IORG \< 0007849 \> \< Medicine Invention Design Incorporation \> | View source |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 16, 2025 | Jul 6, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2025 | Jul 6, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C502994 | saxagliptin |
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