Type 2 Diabetes
Conditions
Keywords
Diabetes, Dapagliflozin, Saxagliptin, Metformin
Brief summary
Use Dapagliflozin 10 mg, Saxagliptin 5 mg, Metformin 500 mg treat type 2 diabetes patients with controlled cancers
Detailed description
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 * Detect Hemoglobin A1c (HbA1c) * Detect fasting blood glucose (FBG) * Detect 2-hour postprandial blood glucose (2 hPBG) * Detect fasting insulin (FINS) * Detect 2-hour postprandial insulin (2 hPINS)
Interventions
DRUGFarxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes
Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription Treat type 2 diabetes patients with controlled cancers
DRUGChina Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes
China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription Treat type 2 diabetes patients with controlled cancers
Sponsors
Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair
UnitedHealthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
No-placebo and random and double blind
Intervention model description
* The usual approach group - 300 double blind random group * The study approach group - 300 double blind random group
Eligibility
Sex/Gender
ALL
Age
24 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Select 600 type 2 diabetes patients with controlled cancers. * Dosage Duration at least 90 days Inclusion Criteria: * 1\. Clinical diagnosis of type 2 diabetes * 2\. Controlled cancers * 3\. Suitable for enough blood-drawing * 4\. Random and double blind * 5\. Measurable disease * 6\. Adequate organ functions * 7\. Adequate performance status * 8\. Age 24 years old and over * 9\. Sign an informed consent form * 10\. Receive blood-drawing
Exclusion criteria
* 1\. Uncontrolled cancers * 2\. Pregnancy * 3\. Breast-feeding * 4\. The patients with other serious intercurrent illness or infectious diseases * 5\. The participating patients have serious side effects. * 6\. Serious Allergy to Drugs * 7\. Thrombus or Bleed Tendency * 8\. Serious Risks or Serious Adverse Events of the drug product * 9\. The prohibition of drug products * 10\. Have no therapeutic effects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detect Hemoglobin A1c (HbA1c) | Duration up to 90 days | Draw blood Detect Hemoglobin A1c (HbA1c) |
| Detect fasting blood glucose (FBG) | Duration up to 90 days | Draw blood Detect fasting blood glucose (FBG) |
| Detect 2-hour postprandial blood glucose (2 hPBG) | Duration up to 90 days | Draw blood Detect 2-hour postprandial blood glucose (2 hPBG) |
| Detect fasting insulin (FINS) | Duration up to 90 days | Draw blood Detect fasting insulin (FINS) |
| Detect 2-hour postprandial insulin (2 hPINS) | Duration up to 90 days | Draw blood Detect 2-hour postprandial insulin (2 hPINS) |
Countries
United States
Contacts
STUDY_CHAIRHAN ID XU, MD/PhD/FAPCR
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
STUDY_DIRECTORHAN ID XU, MD/PhD/FAPCR
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
PRINCIPAL_INVESTIGATORHAN ID XU, MD/PhD/FAPCR
Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701
Outcome results
None listed