man with diabetes

Diabetes Clinical Development

Therapeutic Expertise Metabolic (Diabetes) and Endocrine Diabetes

Developing new therapies to treat diabetes

The PPD™ clinical research business of Thermo Fisher Scientific has the capabilities to conduct Type 1 and 2 diabetes research in both adult and pediatric patients. Our medical and operational teams are knowledgeable and experienced in managing the unique challenges of diabetes trials, enabling our clients to focus on the right strategic aspects of clinical development to increase their probability of success. 

Contact us to define and finesse the critical path for your program

Our comprehensive experience in diabetes ranges from Type 1 and Type 2 diabetes and related diseases, such as diabetic foot, diabetic nephropathy and retinopathy. Our history of success is fueled by our innovative solutions, including digital and decentralized solutions, and our deep expertise in the field supported by relationships with key opinion leaders. 

With us, you get expertise in the unique and novel aspects of diabetes research: 

Differentiation of your drug from products available for Type 2 diabetes treatment; customizing Type 1 diabetes studies We design and implement studies to help patients and providers choose and recommend individualized solutions.
The latest in diabetes regulatory knowledge We incorporate the March 2020 U.S. Food and Drug Administration regulatory guidance in diabetes study design, with an emphasis on recruitment of trial subjects who mirror the genetic and ethnic background of your drug target population.
Exploration of diabetes-related comorbidities We employ digital solutions built around diabetes-related comorbidities.
Our evidence-based working group

We provide expertise and insights into real-world data research and relevant outcomes for your drug development pathway.

The resources needed to achieve success in diabetes clinical trials

A suite of innovative solutions enables success in diabetes clinical trials, including:  

  • Access to advanced continuous glucose monitoring (CGM) technology and expertise in the design and regulatory requirements for CGM studies. Our in-house capabilities cover the design, implementation and publication of CGM trials, supported by expert biostatistics teams for rapid deployment of CGM infrastructure. 
  • A centralized registered dietitian partnership to offer an adaptable diet and exercise program ensuring a consistent diet and exercise approach is achieved at each site through the development of training programs. 
  • Solutions centered around increasing patient diversity within trials, from startup interventions and trial design to trial enrollment and retention, supported by patient advocacy and community strategy.  
Boy with metabolic diabetes

Diabetes treatment study design for Phase I-IV programs

Our team is well equipped with operational and medical fundamentals and novel approaches to chart a path forward for your therapy. We invest in solutions and groups that improve diabetes study quality for our clients and patients.

  • Insulin or glucose clamp paradigms at our Phase I units
  • Understanding of adverse events of special interest by product class
  • Comprehensive, global central labs services; biomarkers of inflammation and immunomodulation
  • Hyperglycemia or hypoglycemia rescue
  • Mixed meal tolerance test; oral glucose tolerance test
  • Diabetes-related comorbidities such as cardiovascular outcome (CVOT) trials

Partner with us on your diabetes development program

Our teams know how to deliver mission-critical solutions for diabetes research. After assessing your goals, we’ll work with you to define and finesse the critical path for your program.