Diabetes Clinical Trials: Breaking barriers in clinical research for advanced therapies

As a trusted diabetes CRO, we’re honoured to recognize World Diabetes Day and this year’s theme, 'Breaking Barriers and Bridging Gaps.' This theme calls on us to confront the critical challenges and inequalities that prevent effective diabetes care. Millions around the world struggle to access the healthcare, education, and resources they need to manage diabetes.

Advancing Next-Generation Diabetes Treatments

At Navitas Lifesciences, we are committed to bridging these gaps by managing efficient diabetes clinical trials that bring innovative treatments to those who need them most. Notable examples include Liraglutide (a GLP-1 receptor agonist that enhances insulin secretion and suppresses glucagon release), Semaglutide (another GLP-1 receptor agonist shown to improve glycemic control and support weight loss), and Glargine (a long-acting insulin analog that provides stable basal insulin levels).

Our experience in clinical trials for diabetes span numerous therapeutic classes, including biosimilar insulin, across the biosimilar pipeline, enabling us to deliver high-quality data and insights that directly influence clinical and regulatory outcomes. We have conducted trials across all phases of drug development, adapting our methodologies to the specific requirements of each study.

Overcoming Challenges in Clinical Trials for Diabetes

Through collaborations with leading pharmaceutical sponsors, we have addressed significant challenges in diabetes trials, such as variable patient responses, diverse metabolic needs, and the integration of real-world evidence. Our team has implemented strategies to improve recruitment and retention, particularly for underserved populations where the impact of these therapies can be profound.

Robust Protocol Development for Complex Diabetes Studies: Diabetes trials often require customized protocols to account for varying patient profiles, comorbidities, and individual treatment responses. Our team brings a wealth of experience in designing robust protocols that ensure reliable data collection, meaningful outcome measures, and adherence to regulatory standards.

• We implement adaptive trial designs that allow for protocol adjustments based on early study findings. This flexibility is particularly valuable in diabetes trials, where patient response to treatments can vary significantly.
• These adaptive protocols have reduced patient dropout rates and enhanced the reliability of our trial outcomes, allowing for more accurate assessments of therapeutic efficacy.

Patient-Centric Recruitment and Retention Strategies: Recruiting and retaining participants for diabetes trials can be challenging, given the long-term commitment and daily management diabetes requires. Our team employs advanced, proven techniques in patient engagement to ensure a stable and committed participant base.

• We use a tailored outreach strategy based on in-depth patient profiling, which involves demographic insights, medical history, and lifestyle analysis to identify and engage the right participants in collaboration with the Principal Investigators.
• Our approach has resulted in 30% increase in retention rates for diabetes studies, ensuring consistent and high-quality data throughout the trial lifecycle.

Euglycemic Clamp Studies

Navitas Life Sciences stands has extensive experience and cutting-edge capabilities in euglycemic clamp studies, considered the gold standard for assessing insulin sensitivity in humans. Our capabilities enable us to measure the glucose-lowering effect of biosimilar insulin compounds using a variable glucose infusion rate (GIR). With a focus on precision and safety, our experts ensure constant monitoring of subjects throughout the study, employing advanced instrumentation such as glucose analyzers, ECLIA analyzers, and highly sensitive triple quad mass spectrophotometers.

Biosimilar Insulin Development:

Our state-of-the-art equipment and methodologies expedite the development process, adhering with US FDA biosimilar guidelines, positioning your biosimilar insulin for market entry ahead of competitors. Key capabilities include the precise euglycemic glucose clamp technique, constant safety monitoring, and regulatory compliant, validated methods for estimating insulin, analogs, and metabolites.

Advanced Biomarker and Endpoint Analysis with Real-Time Safety Monitoring

Our comprehensive approach to biomarker analysis and real-time monitoring at Navitas Lifesciences leverages cutting-edge tools to capture precise data critical for understanding diabetes therapies. We utilize continuous glucose monitoring (CGM) devices and wearable technology to track glycemic variations in real-time, yielding granular data that supports both primary and exploratory endpoints. By incorporating CGM, we gain insight beyond traditional biomarkers like HbA1c, allowing us to evaluate treatment efficacy in diverse and nuanced patient populations.

Enhancing Diabetes Trial Insights with OneClinical^®

Through our OneClinical^® analytical platform, this real-time data is seamlessly integrated, empowering our medical monitoring team to access and assess patient data as it unfolds. This enables early identification of safety signals and prompt intervention when necessary, providing an additional layer of proactive risk management. Real-time insights ensure that our monitoring and safety assessment remain adaptive to patient needs, preserving both data quality and trial integrity. Furthermore, the immediate availability of these metrics helps facilitate regulatory compliance and supports a faster pathway to approvals by providing sponsors with actionable insights at each stage.

Efficient Data Management for Reliable Diabetes Clinical Trial Outcomes

Navitas Lifesciences employs streamlined data management processes that ensure data integrity, accuracy, and compliance across all phases of diabetes trials.

• Automated data validation and edit checks streamline data processing, reducing errors and ensuring high-quality outcomes for critical endpoints.
• Real-time data monitoring tools enable swift query management, minimizing delays and keeping trials on track for timely analysis and regulatory submissions.

Bridging Gaps in Access and Adherence One of the greatest obstacles in diabetes care is ensuring that therapies not only reach but are utilized effectively by the people who need them. Navitas Life sciences has designed studies that account for Real World Data, gathering data on factors like patient lifestyle, socioeconomic constraints, and access to healthcare resources.

Partner with Us to Break Barriers in Diabetes Care As we continue to push boundaries in diabetes research, we invite sponsors, researchers, and healthcare providers to trust us to manage their diabetes clinical trials. If you’re looking for a well-known diabetes CRO with a deep commitment to impactful, patient-centered diabetes studies, reach out to us at Navitas Lifesciences.

Efficient Euglycemic Clamp Studies to bring effective anti-diabetic therapies to augment market reach

Navitas Life Sciences has the capabilities and resources to enable biosimilars companies to bring effective anti-diabetic therapies to the market quickly and safely.

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