A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

Recruiting at143 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this clinical research study is to learn if BMS-512148 is effective in controlling blood sugar levels as determined by HbA1c and fasting plasma glucose in patients who have been diagnosed with Type 2 diabetes. Patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). The safety of BMS512148 will also be studied

Research Team

Bristol Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Serum creatinine < 1.5 mg/dL for men or < 1.4 mg/dL for women.

No overt proteinuria (microalbumin/creatinine ratio must be <300 mg/g

Patient either has not been previously treated with antihyperglycemic medication or has been treated for <30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days.

Treatment Details

Interventions

• dapagliflozin (Sodium-glucose cotransporter 2 (SGLT2) inhibitor)
• metformin (Biguanide)
• placebo (Drug)

Participant Groups

Group I: Arm 5 Experimental Treatment 1 Intervention

Group II: Arm 4 Experimental Treatment 1 Intervention

Group III: Arm 3 Experimental Treatment 1 Intervention

Group IV: Arm 2 Experimental Treatment 1 Intervention

Group V: Arm 1 Experimental Treatment 1 Intervention

Group VI: Arm 7 Active Control 1 Intervention

Group VII: Arm 6 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania