Therapeutic Expertise
Diabetes, Metabolic & Endocrine
Our metabolic and endocrine team runs trials in diabetes, obesity, dyslipidaemia and endocrine disorders, with the CVOT and glycaemic-endpoint expertise these programmes demand.
Metabolic programmes carry specific regulatory expectations — cardiovascular outcome (CVOT) safety for diabetes drugs, HbA1c and glycaemic endpoints, and body-weight and lipid measures with defined analysis standards. We design efficient studies that meet these expectations and leverage Australia’s R&D incentives.
Addressing common pain points in diabetes, metabolic & endocrine clinical trials
Cardiovascular safety expectations
Diabetes therapies face CVOT safety requirements that add cost and complexity.
We align safety and outcome strategy with FDA cardiovascular-risk guidance from the outset.
Glycaemic and weight endpoint rigour
HbA1c and body-weight endpoints require standardised, well-controlled measurement.
We standardise measurement, central labs and dietary/lifestyle controls to protect the signal.
Long-duration adherence and retention
Metabolic trials often run long, risking dropout and non-adherence.
We use DCT elements and engagement programmes to sustain adherence and retention.
Resources
Diabetes, Metabolic & Endocrine clinical trial resources
Navigating the Complex Landscape of Obesity Clinical Trials
Design and endpoints in obesity research.
Unlocking Success in Hypercholesterolemia Trials
Endpoint strategy in hypercholesterolemia.
Evidence & insights
Diabetes, Metabolic & Endocrine white papers
Open-access reports from our physicians and data science teams — free, no sign-in.
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Diabetes, Metabolic & Endocrine clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
Request a proposal