✓ Translated by DotMD AI Clinical Council Source: Diabetes, obesity & metabolism • Randomized Controlled Trial
Verify Primary Source: NIH PubMed PMID #31144435 ↗

Randomized Controlled Trial: A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study (N = 120)

Original Paper Title: “A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 120
Evidence Classification
Randomized Controlled Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • In patients with HbA1c ≥10% treatment with GLP1RA plus basal insulin, compared with basal-bolus insulin, resulted in better glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life. This treatment strategy is an effective and safe alternative to a basal-bolus insulin regimen.
  • Study Design & Sample: Randomized Controlled Trial published in Diabetes, obesity & metabolism (N = 120 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Diabetes, obesity & metabolism (2019), this randomized controlled trial evaluating 120 human participants investigated: To compare the efficacy and safety of a glucagon-like peptide-1 receptor agonist (GLP1RA) plus basal insulin versus basal-bolus insulin treatment in patients with very uncontrolled type 2 diabetes. Key clinical takeaway: In patients with HbA1c ≥10% treatment with GLP1RA plus basal insulin, compared with basal-bolus insulin, resulted in better glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life. This treatment strategy is an effective and safe alternative to a basal-bolus insulin regimen.

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

Primary Endpoint & Quantitative Summary (Diabetes, obesity & metabolism, 2019-09-15; N = 120; Rigor 82/100): In patients with HbA1c ≥10% treatment with GLP1RA plus basal insulin, compared with basal-bolus insulin, resulted in better glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life. This treatment strategy is an effective and safe alternative to a basal-bolus insulin regimen.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Randomized Controlled 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.

Related DotMD Clinical Hubs & Price Ledgers

Rx: insulin-aspart → Rx: insulin-aspart-szjj → Rx: glucose-and-sodium-chloride-dextrose-anhydrous-and-sodium-chloride → Rx: zinc-cold-therapy-zinc-gluconate → Condition: blood-glucose → Condition: body-weight → Condition: diabetes →
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about PMID 31144435: Randomized Controlled Trial: A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study (N = 120)

3 of 3 Free Questions Remaining