Gelteq Provides Corporate Update: Launching Veterinary and Human Clinical Trials, Pharmaceutical Pipeline Expanding Across Multiple Programs

Global glycaemic control gap: In 2023, only 55.8% of people with diabetes aged 15 years and older were diagnosed globally. Among those diagnosed, 91.4% were on treatment, yet only 41.6% of treated individuals achieved optimal glycaemic concentrations — reflecting a cascade of attrition from diagnosis through effective control.

Regional and socioeconomic disparities: Unmet need for diabetes care varies dramatically by geography. In Nepal, 95.1% of the diabetic population had unmet care needs (only 4.9% treated and controlled); in Bangladesh, 85.3% remained unmet; and in Bhutan, 64.3%. Humanitarian crises further compound these gaps — in Venezuela, treatment rates declined from 60% (2014–2017) to 51% (2018–2020), with 24% of participants worsening in diabetes management.

Healthcare provider knowledge deficits: A foundational barrier remains at the provider level; only 12% of healthcare providers demonstrated good knowledge of current treatment recommendations — including 17.3% of doctors, 4.1% of nurses, and 11.1% of allied health professionals — resulting in few patients attaining recommended targets for fasting blood glucose or blood pressure.

Insulin initiation and adherence barriers: Insulin is widely regarded as the most challenging and time-consuming treatment modality. Barriers span organizational healthcare constraints, patient reluctance, and suboptimal therapy design. Key unmet needs include better utilization of human and financial resources to promote self-management, greater patient empowerment in treatment decision-making, and refinement of insulin therapy for improved safety, simplicity, and convenience.

Patient-level treatment barriers: Patients' preference for natural treatment methods, inadequate understanding of diabetes pathophysiology, inconsistent meal practices, and forgetfulness contribute to delayed therapy initiation and non-adherence. Patients are particularly likely to delay or discontinue anti-diabetic medications until they fully acknowledge their benefits and necessity.

Cardiovascular risk management gap: Adults with type 2 diabetes and no known coronary artery disease carry a 10-year cardiac event risk comparable to patients without diabetes who have established coronary disease — yet systematic approaches to lipid management and cardiovascular risk reduction remain underutilized relative to the scale of the at-risk population.

Limitations of mobile health and AI-driven systems: Most diabetes mobile health management systems do not meet clinical expectations, lacking standardized management processes and evidence-based intervention recommendations. AI integration into clinical workflows is further hampered by limited data diversity and low model interpretability, which undermine generalizability and erode clinical trust.

Absence of long-term regenerative therapies: Despite promising preclinical signals from mesenchymal stem cells and exosome-based approaches, no long-term safe regenerative therapy has been established, leaving beta-cell restoration an unmet therapeutic objective — particularly for type 1 diabetes.

Tyrosine Kinase Inhibitors (TKIs): TKIs exert anti-hyperglycemic effects by acting on multiple targets — including c-Abl, PDGFR, VEGFR, EGFR, and c-Kit — and produce anti-diabetic effects partly through partial PPAR-γ agonism, improving insulin sensitivity and glucose disposal rate. Established in oncology, TKIs are now being investigated for diabetes management, though their repositioning remains in early-stage research.

Hepatoselective Glucokinase Activation (TTP399): TTP399 is a hepatoselective glucokinase activator under evaluation in a Phase 2 randomized controlled study for type 2 diabetes. It has demonstrated glucose lowering without the adverse effects typically associated with non-selective glucokinase activators, including hypoglycemia, weight gain, and dyslipidemia. Larger trials are required to establish long-term efficacy and safety across diverse patient populations.

SGLT2 Inhibition in Type 1 Diabetes (Empagliflozin): Empagliflozin, an SGLT2 inhibitor approved for type 2 diabetes, is under investigation as adjunct therapy to insulin in type 1 diabetes (T1DM). Early data indicate favorable effects on HbA1c reduction, body weight, total daily insulin dose, and hypoglycemic event frequency, along with potential renal protection via attenuation of glomerular hyperfiltration. The principal safety concern in this context is an elevated ketone signal, indicative of an under-insulinized state and associated diabetic ketoacidosis risk.

Glycemic Control (Primary Endpoints): Change from baseline in HbA1c is the most consistently used primary endpoint, typically assessed at 12–24 weeks or beyond. Related measures include mean change in fasting plasma glucose (FPG), postprandial glucose response, proportion of patients achieving HbA1c <7%, and C-peptide area under the curve (AUC) — particularly relevant in Type 1 diabetes studies evaluating beta-cell function.

Hypoglycemia and Safety: Hypoglycemic event rates — both nonsevere and major — are standard safety endpoints, measured as events per person per year. Additional safety assessments include gastrointestinal adverse events (nausea, vomiting, diarrhea), Grade 3/4 adverse events, serious adverse events, and all-cause mortality.

Cardiovascular Outcomes: Evaluation of cardiovascular endpoints is now a regulatory expectation for antihyperglycemic agents in late-stage development. Endpoints include myocardial infarction, stroke, heart failure, angina, sudden death, and cardiovascular mortality — often assessed in noninferiority frameworks to establish absence of harm, with select agents demonstrating statistically significant reductions in cardiovascular events.

Metabolic and Cardiometabolic Parameters: Secondary endpoints routinely include body weight change, daily insulin dose requirements, LDL-cholesterol, total cholesterol, triglycerides, HDL cholesterol, and blood pressure (systolic and diastolic). In pre-diabetes and Type 2 diabetes populations, cardiometabolic risk factor profiles — including total-to-HDL cholesterol ratio and inflammation markers — are also evaluated, with documented sex-based differences in risk phenotype.

Endpoint Heterogeneity Across Trials: A systematic review of 138 registered diabetes trials identified 1,444 outcomes across 30 distinct domains, with a median of 8 outcomes per trial (range 1–60). No single domain or outcome was measured universally; 88% of trials included outcomes in the metabolism and nutrition domain (HbA1c: 18%; hypoglycaemia: 14%; FPG: 11%), while patient-reported outcomes appeared in only 10% of trials — of which 29% used the Diabetes Treatment Satisfaction Questionnaire.

Health Economics and Quality of Life: Emerging endpoint categories include quality-adjusted life years (QALYs) gained, incremental cost-effectiveness ratios (ICERs), lifetime complication-related costs, and health-related quality of life assessments — increasingly relevant for payer-facing evidence packages and value-based access strategies.