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AzTrials

Type 2 DiabetesPhase 2/3GD-T2DNCT07033585

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

A Phase 2/3 study testing Farxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes and China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes in people with Type 2 Diabetes, run by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Use Dapagliflozin 10 mg, Saxagliptin 5 mg, Metformin 500 mg treat type 2 diabetes patients with controlled cancers Read more about this study

Who is it for?
Ages 24 to 64 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Farxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes and China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
15 Jun 2026to 28 Nov 2026
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 7. Adequate performance status
  • 8. Age 24 years old and over
  • 9. Sign an informed consent form
  • 10. Receive blood-drawing

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

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

    Rockville, Maryland, 20853

Other trials in United States

About this study

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

Read the 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)
Conditions
Type 2 Diabetes
Being tested
Farxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes, China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes
Keywords
Diabetes, Dapagliflozin, Saxagliptin, Metformin
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Farxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetesDrug

    Also called The usual approach group 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

  • China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetesDrug

    Also called The study approach group 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

Study groups in NCT07033585
Study groupRoleWhat they receive
Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral MixExperimentalFarxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription
Receives: 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 MixExperimentalChina Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription
Receives: Drug: China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detect Hemoglobin A1c (HbA1c)

    Draw blood Detect Hemoglobin A1c (HbA1c)

    Measured: Duration up to 90 days

  2. Detect fasting blood glucose (FBG)

    Draw blood Detect fasting blood glucose (FBG)

    Measured: Duration up to 90 days

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

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

    Measured: Duration up to 90 days

  4. Detect fasting insulin (FINS)

    Draw blood Detect fasting insulin (FINS)

    Measured: Duration up to 90 days

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

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

    Measured: Duration up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start15 Jun 2026
  3. Primary completion18 Oct 2026 (estimated)
  4. Study completion28 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
* The usual approach group - 300 double blind random group * The study approach group - 300 double blind random group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07033585
Sponsor's protocol ID
ANDA219975 + ANDA220011
Other IDs
NPI-1831468511, NPI-1023387701, FWA00015357, IORG0007849, IRB00009424, ANDA219975, ANDA220011
Acronym
GD-T2D
Status last verified
Aug 2026
First submitted
16 Jun 2025
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31852646

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Farxiga® (dapagliflozin) + Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes and China Import (dapagliflozin) + China Import (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes in people with Type 2 Diabetes, run by Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detect Hemoglobin A1c (HbA1c) (time frame: Duration up to 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07033585, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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