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

NCT07033585 | Active Not Recruiting Phase 2 DMC FDA Drug

• 8 other identifiers: ANDA219975 + ANDA220011NPI-1831468511NPI-1023387701FWA00015357IORG0007849IRB00009424ANDA219975ANDA220011
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes

Keywords

Diabetes; Dapagliflozin; Saxagliptin; Metformin

Outcome Measures

Primary Outcomes (5)

• Detect Hemoglobin A1c (HbA1c)

  Draw blood Detect Hemoglobin A1c (HbA1c)

  Duration up to 90 days

• Detect fasting blood glucose (FBG)

  Draw blood Detect fasting blood glucose (FBG)

  Duration up to 90 days

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

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

  Duration up to 90 days

• Detect fasting insulin (FINS)

  Draw blood Detect fasting insulin (FINS)

  Duration up to 90 days

• Detect 2-hour postprandial insulin (2 hPINS)

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

  Duration up to 90 days

Study Arms (2)

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

EXPERIMENTAL

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

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

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

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

Interventions

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

Also known as: The usual approach group Oral Mix Treat type 2 diabetes

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

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

Also known as: 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

Eligibility Criteria

• Age: 24 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Clinical diagnosis of type 2 diabetes
• \. Controlled cancers
• \. Suitable for enough blood-drawing
• \. Random and double blind
• \. Measurable disease
• \. Adequate organ functions
• \. Adequate performance status
• \. Age 24 years old and over
• \. Sign an informed consent form
• \. Receive blood-drawing

You may not qualify if:

• \. Uncontrolled cancers
• \. Pregnancy
• \. Breast-feeding
• \. The patients with other serious intercurrent illness or infectious diseases
• \. The participating patients have serious side effects.
• \. Serious Allergy to Drugs
• \. Thrombus or Bleed Tendency
• \. Serious Risks or Serious Adverse Events of the drug product
• \. The prohibition of drug products
• \. Have no therapeutic effects

Sponsors & Collaborators

• Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair: lead
• UnitedHealthcare: collaborator

Study Sites (1)

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

Rockville, Maryland, 20853, United States

Location

Related Publications (1)

• 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.

  PMID: 31852646 RESULT

Related Links

• FWA \< 00015357 \> \< Medicine Invention Design Incorporation \>
• IRB \< 00009424 \> \< Medicine Invention Design Incorporation \>
• IORG \< 0007849 \> \< Medicine Invention Design Incorporation \>

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

dapagliflozin; saxagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• HAN ID XU, MD/PhD/FAPCR

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

  STUDY CHAIR

• HAN ID XU, MD/PhD/FAPCR

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

  STUDY DIRECTOR

• HAN ID XU, MD/PhD/FAPCR

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No-placebo and random and double blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Model Details: * The usual approach group - 300 double blind random group * The study approach group - 300 double blind random group

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 24, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)