Dapagliflozin + Saxagliptin + Metformin for Type 2 Diabetes

(GD-T2D Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

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

Disqualifiers: Uncontrolled cancers, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of three medications—dapagliflozin, saxagliptin, and metformin—to evaluate their effectiveness in managing type 2 diabetes in patients with controlled cancer. The study aims to determine if this medication mix can effectively control blood sugar levels without causing major side effects. This trial may suit individuals diagnosed with type 2 diabetes, who have their cancer under control, and are comfortable with regular blood tests. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking diabetes treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking dapagliflozin, saxagliptin, and metformin together is generally safe and well-tolerated, meaning most people can use these medications without serious side effects. Studies have tested this combination over extended periods, such as 24 weeks and up to 104 weeks, with positive safety outcomes. Participants did not experience major health problems related to the treatment.

Additionally, dapagliflozin and saxagliptin have been used alone and with metformin in other studies, which found them safe for patients, including children, over a year-long trial.

For those considering joining this trial, current research suggests the treatment is safe for most people. However, discussing any concerns with a doctor is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using dapagliflozin and saxagliptin with metformin for Type 2 diabetes because this combination targets the condition in a novel way compared to standard treatments. While most treatments like metformin alone primarily focus on reducing glucose production in the liver, dapagliflozin and saxagliptin offer additional mechanisms. Dapagliflozin works by helping the kidneys remove excess sugar through urine, and saxagliptin boosts insulin production by inhibiting the DPP-4 enzyme. This comprehensive approach could lead to better blood sugar control and potentially fewer side effects.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

This trial will evaluate the combination of dapagliflozin, saxagliptin, and metformin for managing type 2 diabetes. Research has shown that these medications together can effectively lower blood sugar levels. Studies highlight that this combination can reduce HbA1c levels, a measure of long-term blood sugar control, by about 0.5% to 1%. This means it helps maintain blood sugar levels better than using each drug alone. These medications work by helping the body eliminate extra sugar through urine and by improving insulin use. Overall, this combination has proven to be a powerful tool in managing type 2 diabetes. ^{3 6 7 8 9}

Who Is on the Research Team?

HAN ID XU, MD/PhD/FAPCR

Principal Investigator

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

HAN ID XU, MD/PhD/FAPCR

Principal Investigator

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

HAN ID XU, MD/PhD/FAPCR

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for adults over 24 with type 2 diabetes and controlled cancers. Participants must be able to undergo blood draws, have adequate organ function, measurable disease, and sign a consent form. Those with uncontrolled cancer, pregnancy, serious illnesses or allergies to drugs cannot join.

Inclusion Criteria

Random and double blind

Adequate performance status

My cancer can be measured by tests or scans.

Exclusion Criteria

Pregnancy

Breast-feeding

My cancer is not under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dapagliflozin, Saxagliptin, and Metformin to treat type 2 diabetes with controlled cancers

12 weeks

Regular visits for blood tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin
• Saxagliptin

Trial Overview The study tests the combination of Dapagliflozin (10 mg), Saxagliptin (5 mg), and Metformin (500 mg) in treating type 2 diabetes in patients who also have controlled cancers. It's a randomized double-blind trial comparing generic drugs from China against brand names Farxiga® and Onglyza®.

How Is the Trial Designed?

Group I: Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Experimental Treatment 1 Intervention

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

Group II: China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

6

Recruited

2,400+

UnitedHealthcare

Collaborator

Trials

5

Recruited

594,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07033585

Generic Drugs (Dapagliflozin and Saxagliptin) Treat Type 2 ... ... Onglyza® (saxagliptin) + Metformin Oral Mix Treat type 2 diabetes. Farxiga® (dapagliflozin) 10 mg, Onglyza® (saxagliptin) ... type 2 diabetes: efficacy ...

2. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/210874Orig1s000MedR.pdf

210874Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov Trial CV181369 is a noninferiority trial that compared the efficacy and safety of dapagliflozin plus saxagliptin as add-on therapy with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11343913/

Combination Glucose-Lowering Therapy Plans in T2DM Data show that two-drug combinations provide reductions in plasma HbA1c levels of approximately − 0.5% to − 1.0% compared with that achieved by the individual ...

4. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/CV181-169/

Safety and Efficacy of Combination Saxagliptin & ... The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) ...

5. trial.medpath.com trial.medpath.com/clinical-trial/5170a8b8143158f8/nct07033585-dapagliflozin-saxagliptin-type-2-diabetes-cancer

Generic Drugs (Dapagliflozin and Saxagliptin) Treat Type 2 ... Use Dapagliflozin 10 mg, Saxagliptin 5 mg, Metformin 500 mg treat type 2 diabetes patients with controlled cancers.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5969059/

Safety and tolerability of dapagliflozin, saxagliptin and ... In phase 3 trials, triple therapy with dapagliflozin (an SGLT‐2 inhibitor), saxagliptin (a DPP‐4 inhibitor) and metformin reduced 24‐week HbA1c to a greater ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02613897

ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study Treatment with saxagliptin and dapagliflozin, both individually and in combination with metformin, have demonstrated a favorable safety and tolerability profile ...

8. academic.oup.com academic.oup.com/jcem/article/110/6/1587/7835812

Safety, Growth, and Development After Dapagliflozin or ... Safety outcomes assessed over 52 weeks in the T2NOW trial indicated that dapagliflozin and saxagliptin were both well tolerated in a pediatric population over ...

9. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15705

Efficacy and tolerability of initial triple combination therapy ... In conclusion, for 104 weeks, initial TCT with 1 g of metformin, dapagliflozin and saxagliptin effectively lowered HbA1c levels, with higher ...