Developing Diabetes Therapeutics with PPD
PPD has conducted Type 1 and 2 diabetes research in both adult and pediatric patients. Our physicians and operations teams know and manage the unique challenges of diabetes trials and help clients identify the levers they need to pull to increase their probability of success.
With PPD, you get expertise in the unique and novel aspects of diabetes research:
Differentiation of your drug from the pack of 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.
Access to leading-edge continuous glucose monitoring (CGM) technology
PPD knows the design and regulatory requirements for studies involving CGM, including digital monitoring solutions for glycemic endpoints and other important markers of potential macro and microvascular disease progression and endpoint determination.
The latest in diabetes regulatory knowledge
We incorporate the March 2020 U.S. Food and Drug Administration regulatory guidance in diabetes study design, with a renewed 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 such as cardiac outcome and lipid trials.
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 continue to invest in solutions and groups that improve diabetes study certainty and 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 cardiac outcome and lipid trials
- Lipids profiles including more atherogenic lipoprotein subfractions
Partner with PPD 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.