Control of Postprandial Hyperglycemia in Type 1 Diabetes by 24-Hour Fixed-Dose Coadministration of Pramlintide and Regular Human Insulin: A Randomized, Two-Way Crossover Study
Riddle MC; Nahra R; Han J; Castle J; Hanavan K; Hompesch M
Diabetes care
- PubMed
- 30213882
- Evidence level
- low_to_moderate
- Verification
- verified
Summary
Riddle et al. 2018 (Diabetes Care) single-masked 24-h crossover pharmacodynamic study in T1D showing that fixed-ratio co-infusion of pramlintide with regular human insulin (9 μg/unit) reduced mean 24-h CGM glucose from 9.7 to 8.5 mmol/L (p=0.012), reduced glycaemic variability, and lowered postprandial glucagon and triglycerides vs placebo, with more frequent gastrointestinal side effects and no major hypoglycaemia.
Limitations
Declared COI / funding signal (SEPARATE from methodological RoB): two authors are AstraZeneca employees (Gaithersburg, MD), and the study is a commercial-development-context pharmacodynamic trial. Methodological limitations (SEPARATE from COI): short 24-h inpatient design; per-arm n not stated in abstract; single-masked rather than double-blind (a documented partial-blinding limitation, but not a positive high-RoB defect); primary endpoint clearly pre-specified as mean 24-h CGM glucose with reported point estimate and p-value.