Safety of Intranasal Insulin in Type 2 Diabetes on Systemic Insulin: A Double-Blinded Placebo-Controlled Sub-Study of Memaid Trial.

ABSTRACT:

Aims

To determine safety of intranasal insulin (INI) in MemAID trial participants with diabetes treated with systemic insulins.

Materials and methods

This randomized, double-blinded trial consisted of 24-week INI or placebo treatment once daily and 24-week follow-up. Safety outcomes were: 1) Short-term effects on glycemic variability, hypoglycemic episodes on continuous glucose monitoring (CGM) at baseline and on-treatment. 2) Long-term effects on glucose metabolism and weight on INI/placebo treatment and post-treatment follow-up. Of 86 screened subjects, 14 were randomized, 9 (5 INI, 4 Placebo) completed CGM at baseline and on-treatment, and 5 (2 INI, 3 Placebo) completed treatment and follow-up.

Results

INI was safe and was not associated with serious adverse events

SUBMITTER: Aponte Becerra L 

PROVIDER: S-EPMC9328174 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature