Generic Drugs (Dapagliflozin and Saxagliptin) Treat Type 2 Diabetes Patients With Controlled Cancers (GD-T2D)

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Farxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes; Drug: China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07033585

NPI-1831468511 (Registry Identifier)

IRB00009424 (Registry Identifier)

ANDA219975 (Registry Identifier)

ANDA219975 + ANDA220011

FWA00015357 (Registry Identifier)

ANDA220011 (Registry Identifier)

NPI-1023387701 (Registry Identifier)

IORG0007849 (Registry Identifier)

Details and patient eligibility

About

Use Dapagliflozin 10 mg, Saxagliptin 5 mg, Metformin 500 mg treat type 2 diabetes patients with controlled cancers

Full 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)

Enrollment: 600 estimated patients

Sex: All

Ages: 24 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix

Experimental group

Description:

Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription

Treatment:

Drug: Farxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes

China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix

Experimental group

Description:

China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription

Treatment:

Drug: China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes