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Dataset Information

Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial.


ABSTRACT:

Aim

To evaluate the efficacy and safety of mealtime or post-meal fast-acting insulin aspart (faster aspart) vs mealtime insulin aspart (IAsp), both in combination with insulin degludec, in participants with type 1 diabetes (T1D).

Methods

This multicentre, treat-to-target trial (Clinical trial registry: NCT02500706, ClinicalTrials.gov) randomized participants to double-blind mealtime faster aspart (n = 342) or IAsp (n = 342) or open-label post-meal faster aspart (n = 341). The primary endpoint was change from baseline in HbA1c 26 weeks post randomization. All available information, regardless of treatment discontinuation, was used for evaluation of the effect.

Results

Non-inferiority for the change from baseline in HbA1c was confirmed for mealtime and post-meal faster

SUBMITTER: Buse JB 

PROVIDER: S-EPMC6231963 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature