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

Phase 3Active Not RecruitingNCT07033585

Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair600 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

600

Conditions

Type 2 Diabetes

Interventions

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

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

China Import (dapagliflozin) 10 mg, China Import (saxagliptin) 5 mg, Metformin 500 mg, Oral Mix Prescription Treat type 2 diabetes patients with controlled cancers

Eligibility

Sex: ALLMin age: 24 YearsMax age: 64 Years

Medical Language ↔ Plain English

* 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

Locations (1)

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

Rockville, Maryland, United States