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✓ Translated by DotMD AI Clinical Council Source: Endocrine journal • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #33390422 ↗

Phase III Randomized Trial: Efficacy and safety of fast-acting insulin aspart compared with insulin aspart in combination with insulin degludec in Japanese adults with type 1 diabetes: a subgroup analysis of the randomized onset 8 trial (N = 83)

Original Paper Title: “Efficacy and safety of fast-acting insulin aspart compared with insulin aspart in combination with insulin degludec in Japanese adults with type 1 diabetes: a subgroup analysis of the randomized onset 8 trial”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 83
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Rates of overall hypoglycemia (35.56, 37.72 and 38.75 per patient-year of exposure with mealtime fast-acting insulin aspart, post-meal fast-acting insulin aspart and insulin aspart, respectively) and meal-related hypoglycemia were similar between treatment arms.
  • Study Design & Sample: Phase III Randomized Trial published in Endocrine journal (N = 83 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Endocrine journal (2021), this phase iii randomized trial evaluating 83 human participants investigated: This study aimed to confirm the efficacy and safety of mealtime and post-meal fast-acting insulin aspart versus insulin aspart, both with basal insulin degludec, in Japanese patients with type 1 diabetes. Key clinical takeaway: Rates of overall hypoglycemia (35.56, 37.72 and 38.75 per patient-year of exposure with mealtime fast-acting insulin aspart, post-meal fast-acting insulin aspart and insulin aspart, respectively) and meal-related hypoglycemia were similar between treatment arms.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Endocrine journal, 2021-04-28; N = 83; Rigor 82/100): Rates of overall hypoglycemia (35.56, 37.72 and 38.75 per patient-year of exposure with mealtime fast-acting insulin aspart, post-meal fast-acting insulin aspart and insulin aspart, respectively) and meal-related hypoglycemia were similar between treatment arms.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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