Driving Innovations in Diabetes Clinical Trials
With decades of experience across all phases of diabetes research, Medpace is a proven partner in the design and execution of clinical trials targeting type 1, type 2, and rare forms of diabetes. Our in-house endocrinologists, regulatory experts, and operational leaders provide strong therapeutic insight and hands-on collaboration to partner with Sponsors to address the unique challenges of endocrine and metabolic drug development.
Our comprehensive CRO services are supported by our fully integrated, global central labs, bioanalytical lab, ECG core lab, and imaging capabilities. This built-in collaboration of working with a single vendor facilitates a streamlined model for overseeing and executing complex diabetes programs, enabling rapid, high-quality execution across all phases of development.
Medpace Experience in Diabetes:
Making the Complex Seamless® in Diabetes Clinical Development
Expertise Across the Diabetes Landscape
Medpace has supported a wide range of studies in diabetes and related metabolic diseases. Our global network of diabetes-experienced investigators, combined with strong KOL relationships, allows us to reach diverse patient populations and drive enrollment in complex studies. We’ve successfully led trials in:
- Type 1 Diabetes (T1D) and Type 2 Diabetes (T2D), from first-in-human agents to global Phase III trials and cardiovascular outcomes
- Diabetic complications such as nephropathy, retinopathy, neuropathy, and cardiopathy
- Comorbid metabolic disorders, including obesity, MASLD/MASH, and dyslipidemia
- Patient populations ranging from treatment-naïve to those on monotherapy, multiple OADs, or insulin
- Therapeutic modalities including small molecules, biologics, biosimilars, advanced cell and gene therapies, and medical devices – across oral, injectable, and inhaled routes of administration
Our scientifically driven teams stay at the forefront of evolving diabetes treatment strategies, offering guidance on endpoint selection, regulatory strategy, biomarker incorporation, and emerging technologies.
Optimized Site Selection with Proven Partnerships
Accelerate your diabetes programs through Medpace’s data-driven feasibility strategy and strong site relationships. Our IntelliPACE® model utilizes internal and external data sources to pinpoint the most suitable countries and sites, while our dedicated patient recruitment and retention team ensures expedited enrollment and reduced dropouts.
Further enhance your site selection through Medpace Flagship Sites – an established group of top performing global sites and site networks with a proven track record of delivering timely, quality outcomes. Our deep, long-standing relationships with these sites, along with preferred partnerships with key site networks in the U.S. and Europe, streamline study start-up, enhance patient recruitment, and ensure high-quality data capture. Regular engagement with site leaders keeps studies running efficiently while maintaining Medpace’s high standards for study execution.
Comprehensive Lab Support
Medpace’s central laboratories have unparalleled experience and expertise in the development of diabetes therapies. Our wholly-owned central laboratories operate globally – delivering seamless logistics, harmonized data, and consistent quality across continents. Our labs offer robust expertise in endocrine and metabolic biomarkers critical to diabetes trials, including:
- HbA1c, fasting glucose, C-peptide, and insulin levels
- Lipid profiles, inflammatory markers, and liver enzymes
- Advanced assays for beta-cell function and insulin resistance
In parallel, our bioanalytical lab supports PK/PD studies for small molecules, biologics, and biosimilars with validated assays across a range of matrices.
Cardiometabolic Imaging and Safety Integration
For diabetes trials with cardiovascular endpoints or complications, Medpace provides integrated imaging and ECG core lab capabilities. Our board-certified cardiologists, endocrinologists, and radiologists bring extensive experience in a range of modalities, including:
- Computed Tomography (CT)
- Magnetic Resonance Elastography (MRE)
- Magnetic Resonance Imaging (MRI)
- Dual-Energy X-Ray Absorptiometry (DXA)
- Cardiac Safety: ECG, Holter TQT
- Ambulatory Blood Pressure
This end-to-end support ensures regulatory alignment and high-quality safety and efficacy data – especially for programs with metabolic-cardiovascular overlap.
Driving Success with Continuous Glucose Monitoring (CGM)
Continuous glucose monitoring is reshaping how diabetes is studied, offering real-time insights that go beyond traditional endpoints. Medpace supports Sponsors in designing trials that incorporate CGM-derived measures such as time in range and glycemic variability – aligning with regulatory expectations while capturing meaningful clinical outcomes.
Our team has experience integrating data from leading CGM platforms and pairing devices with therapies and delivery systems in both drug and device trials. From protocol design and data analysis to hybrid and decentralized models, Medpace provides the strategic guidance and operational support to fully leverage CGMs in advancing diabetes research.
