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NCT Number: NCT07033585

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

24 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

Rockville, Maryland, 20853, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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

Other names: The usual approach group Oral Mix Treat type 2 diabetes

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

Other names: The study approach group Oral Mix Treat type 2 diabetes

Primary outcomes

  1. Detect Hemoglobin A1c (HbA1c)

    Time frame: Duration up to 90 days

    Draw blood Detect Hemoglobin A1c (HbA1c)

  2. Detect fasting blood glucose (FBG)

    Time frame: Duration up to 90 days

    Draw blood Detect fasting blood glucose (FBG)

  3. Detect 2-hour postprandial blood glucose (2 hPBG)

    Time frame: Duration up to 90 days

    Draw blood Detect 2-hour postprandial blood glucose (2 hPBG)

  4. Detect fasting insulin (FINS)

    Time frame: Duration up to 90 days

    Draw blood Detect fasting insulin (FINS)

  5. Detect 2-hour postprandial insulin (2 hPINS)

    Time frame: Duration up to 90 days

    Draw blood Detect 2-hour postprandial insulin (2 hPINS)

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • UnitedHealthcare

Registry information

Acronym: GD-T2D

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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