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Study · Randomized controlled trial · n = 455 · 2006

2 results

Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes.

Secnik Boye K, Matza LS, Oglesby A, Malley K, Kim S, Hayes RP, Brodows R

Health and quality of life outcomes11 Oct 2006Cited by 56 (Europe PMC)

Summary

BackgroundPatient-reported measures can be used to examine whether drug differences other than clinical efficacy have an impact on outcomes that may be important to patients. Although exenatide and insulin glargine appear to have similar efficacy for treatment of type 2 diabetes, there are several differences between the two treatments that could influence outcomes from the patient's perspective. The purpose of the current study was to examine whether the two drugs were comparable as assessed by patient-reported outcomes using data from a clinical trial in which these injectable medications were added to pre-existing oral treatment regimens.MethodsPatients were randomized to either twice daily exenatide or once daily insulin glargine during a 26-week international trial. At baseline and endpoint, five patient-reported outcome measures were administered: the Vitality Scale of the SF-36, The Diabetes Symptom Checklist - Revised (DSC-R), the EuroQol EQ-5D, the Treatment Flexibility Scale (TFS), and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Change from baseline to endpoint was analyzed within each treatment group. Group differences were examined with General linear models (GLMs), controlling for country and baseline scores.ResultsA total of 549 patients with type 2 diabetes were enrolled in the trial, and current analyses were conducted with data from the 455 per protocol patients (228 exenatide and 227 insulin glargine). The sample was primarily Caucasian (79.6%), with slightly more men (55.2%) than women, and with a mean age of 58.5 years. Paired t-tests found that both treatment groups demonstrated statistically significant baseline to endpoint change on several of the health outcomes instruments including the DSC-R, DTSQ, and the SF-36 Vitality subscale. GLMs found no statistically significant differences between groups in change on the health outcomes instruments.ConclusionThis analysis found that both exenatide and insulin glargine were associated with significant improvements in patient-reported outcomes when added to oral medications among patients with type 2 diabetes. Despite an additional daily injection and a higher rate of gastrointestinal adverse events, treatment satisfaction in the exenatide group was comparable to that of the glargine group, possibly because of weight reduction observed in patients treated with exenatide.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study2

1 result from studies that gave the peptide. 1 result from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes, change from baseline on the patient-reported outcome instruments (SF-36 Vitality, DSC-R, EQ-5D, TFS, DTSQ) did not differ significantly between exenatide and insulin glargine.

    In plain wordsChanges on the patient-reported measures did not differ significantly between exenatide and insulin glargine.

    Outcome
    No significant changePatient-reported outcome change (SF-36 Vitality, DSC-R, EQ-5D, TFS, DTSQ)
    Study

    n = 455

    Comparator
    Insulin glargine
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    Dose not stated · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    GLMs found no statistically significant differences between groups in change on the health outcomes instruments.
    3 context sentences
    Summary · context
    At baseline and endpoint, five patient-reported outcome measures were administered: the Vitality Scale of the SF-36, The Diabetes Symptom Checklist - Revised (DSC-R), the EuroQol EQ-5D, the Treatment Flexibility Scale (TFS), and the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
    Summary · context
    Patients were randomized to either twice daily exenatide or once daily insulin glargine during a 26-week international trial.
    Summary · context
    A total of 549 patients with type 2 diabetes were enrolled in the trial, and current analyses were conducted with data from the 455 per protocol patients (228 exenatide and 227 insulin glargine).

Studies that did not test the peptide alone1

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

  1. 02HumanNot a test of Exenatide (exendin-4) aloneRandomized controlled trialEfficacy outcome

    In patients with type 2 diabetes, both exenatide and insulin glargine groups showed significant changes on several patient-reported instruments.

    In plain wordsBoth exenatide and insulin glargine groups showed significant changes on several patient-reported measures from baseline.

    Outcome
    Not applicableShared patient-reported changes
    Study

    n = 455

    Outcome group
    Patient-reported outcomes · Whole body

    Source sentences

    Summary
    Paired t-tests found that both treatment groups demonstrated statistically significant baseline to endpoint change on several of the health outcomes instruments including the DSC-R, DTSQ, and the SF-36 Vitality subscale.
    2 context sentences
    Summary · context
    Patients were randomized to either twice daily exenatide or once daily insulin glargine during a 26-week international trial.
    Summary · context
    A total of 549 patients with type 2 diabetes were enrolled in the trial, and current analyses were conducted with data from the 455 per protocol patients (228 exenatide and 227 insulin glargine).

    In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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