Evidence map›Paper›PMID 31803482›Full record

Trial reportBMJ open diabetes research & care2019

Effect of medication adherence on clinical outcomes in type 2 diabetes: analysis of the SIMPLE study.

Sapna Patel, Marconi Abreu, Anna Tumyan, Beverley Adams-Huet, Xilong Li, Ildiko Lingvay

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open diabetes research & care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01966978. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
4.6field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01966978 phase4completed

The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, Parallel-group, Intention to Treat Study

Ran2014Enrolled157Registered outcomes8Posted comparisons0ConditionsDiabetes, Diabetes Mellitus, Type 2ArmsDetemir, Insulin Aspart, liraglutide, Metformin
Open the trial in the graph
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
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  14. Review
  15. Concept analysis of diabetes-related quality of life.Health and quality of life outcomes · 2025
    Review
  16. The role of medication regimen complexity in diabetes management: a rapid review.Therapeutic advances in endocrinology and metabolism · 2025
    Review
  17. Review
  18. Article
  19. Article
  20. Factors Associated With Improved A1C Values Among People Using High-Dose Insulin With Uncontrolled Type 2 Diabetes.Clinical diabetes : a publication of the American Diabetes Association · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Sapna PatelEndocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.ORCID 0000-0002-8069-9012
Marconi AbreuEndocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.
Anna TumyanEndocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.
Beverley Adams-HuetPopulation and Data Sciences, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.
Xilong LiPopulation and Data Sciences, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.
Ildiko LingvayEndocrinology, Diabetes and Metabolism, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.
The University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: Medication adherence is impacted by regimen complexity. The SIMPLE (Simple basal Insulin titration, Metformin Plus Liraglutide for type 2 diabetes with very Elevated HbA1c) study compared GLP1RA plus basal insulin (GLP1RA+BI) to basal-bolus insulin (BBI) regimen in participants with very uncontrolled type 2 diabetes mellitus (T2DM). This analysis aimed to evaluate medication adherence to GLP1RA+BI compared with BBI, the effect of adherence on clinical and patient-reported outcomes, and baseline predictors of adherence. Research design and methods: This was an analysis of the SIMPLE study based on prespecified outcome. The study took place in pragmatic, real-world setting. A total of 120 adults with T2DM and HgbA1c≥10% were randomized to detemir plus liraglutide, or detemir plus aspart before each meal; 6-month follow-up. The main outcomes evaluated were: adherence, HgbA1c, weight, quality of life, and hypoglycemia. Adherence rate was calculated for each study medication at each follow-up visit; participants were classified as ≥80% or <80% adherent. Result: A higher percentage of participants in the GLP1RA+BI compared with the BBI group had ≥80% adherence to detemir (59.3% vs 35.7%, p=0.02) as well as liraglutide versus aspart (57.4% vs 30.4%, p=0.007). Higher age was predictive of ≥80% adherence (OR per 5-year increment=1.48, 95% CI 1.09 to 2.0, p=0.01). Higher adherence led to greater improvement in HbA1c and weight in both groups. Treatment with GLP1RA+BI compared with BBI led to greater improvement in HbA1c, weight, and quality of life and lower risk of hypoglycemia even after adjusting for the difference in adherence between groups. Conclusions: Adherence was higher with the simplified regimen of GLP1RA+BI compared with BBI. Greater adherence to the simpler regimen amplified the treatment effect on HbA1c, weight, quality of life, and risk of hypoglycemia, yet statistically significant greater benefits were noted even when adjusted for adherence. Trial registration number: NCT01966978.

Indexed as

Drug MonitoringQuality of LifeBiomarkersBlood GlucoseDiabetes Mellitus, Type 2FemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemic AgentsInsulinLiraglutideMaleMedication AdherenceMetforminMiddle AgedBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinLiraglutideMetforminadherence to medicationsglycemic controlhypoglycemiaweight

Identifiers

PMID31803482
PMCPMC6887507
OpenAlexW2990909872

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.