GLY ‐200, an oral pharmacologic duodenal exclusion drug, resulted in positive effects on glucose, lipids and bodyweight in patients with type 2 diabetes: Results of a randomized, double‐blind placebo‐controlled trial
Authors' conclusion
These results suggest duodenal exclusion is possible with an oral polymeric drug and support further development of GLY-200 for the treatment of T2D and obesity.
Study context
- Population
- Patients aged 30–70 years with T2D (HbA1c ≥6.0% to <8.5%) on stable metformin ≥750 mg/day for ≥3 monthsrandomised 1:1:1:1
- Participants
- 51 patients
- Comparison
- GLY-200 0.5, 1.0 or 2.0 g BID vs placebo for 14 days
- Primary endpoint
- Safety and tolerability
Methodological detailsphase 2, placebo-controlled, double-blind, single-centre, inpatient
- Phase 2
- Placebo-controlled
- Double-blind
- Single-centre
- Inpatient
Primary result
As reported in the abstract
- GLY-200 appeared safe and well tolerated
Further findings
Mean, mg/dL
| Outcome | 2.0 g GLY-200 | PBO | Estimate | P value |
|---|---|---|---|---|
| Postprandial glucose AUC0-3HR after standardized meal · Day 14Between 2.0 g GLY-200 and PBO | mean absolute AUC0-3HR difference 178.33 mg/dL*hr (95% CI −327.16 to −29.50) | P = 0.02 | ||
| Postprandial glucose Cmax after standardized meal · Day 14Between 2.0 g GLY-200 and PBO | Cmax difference 50.88 mg/dL (CI −100.23 to −1.54) | P = 0.04 | ||
| Mean change from baseline in fasting serum glucose · Day 14 | −16.1 (SD 22.5) | 12.1 (SD 41.8) |
Food intake, body weight and lipid profiles (exploratory)
- GLY-200 resulted in numerical reductions in food intake, modest decreases in body weight, and improvements in lipid profiles
Safety
Treatment-related TEAEs with GLY-200
- Most frequent related TEAEs were constipation, nausea, diarrhoea and vomiting, all mild
Original publication
GLY ‐200, an oral pharmacologic duodenal exclusion drug, resulted in positive effects on glucose, lipids and bodyweight in patients with type 2 diabetes: Results of a randomized, double‐blind placebo‐controlled trial. Diabetes Obes Metab. Published 6 August 2025. doi:10.
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