Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus

Phase 1 Completed 34 enrolled AstraZeneca Juvenile Diabetes Research Foundation · collab

RandomizedCrossoverSingle-blindTreatment

Summary

This study is designed to investigate the clinical efficacy and safety of pramlintide co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.

Timeline

Start: 2015-08-17
Primary completion: 2016-08-05
Completion: 2016-08-05

Outcome

Met primary endpoint

paper Mean 24-h glucose measured by CGM was lower with pramlintide versus placebo (8.5 vs. 9.7 mmol/L, respectively; P = 0.012) PMID 30213882 ↗

registry p = 0.0118; Least squares mean difference -21.5 (95% CI -37.8 to -5.2) NCT02500979 ↗

Publications

Riddle MC, Nahra R, Han J, Castle J, Hanavan K, Hompesch M, Huffman D, Strange P, Ohman P. 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. Diabetes Care. 2018 Nov;41(11):2346-2352. doi: 10.2337/dc18-1091. Epub 2018 Sep 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pramlintide	Peptide	—	Subcutaneous
Background	Insulin Lispro	Protein / enzyme biologic	—	Subcutaneous
Background	regular insulin	Protein / enzyme biologic	—	Subcutaneous