Impact of Glucagon-Like Peptide-1 Treatments on Patient-Reported Outcomes in Type 2 Diabetes Mellitus
Author(s)
Haiyan Sun, MS1, Jonathon Briggs, PhD2, Zarmina S. Khankhel, MPH1.
1Genesis Research Group, Hoboken, NJ, USA, 2Genesis Research Group, London, United Kingdom.
1Genesis Research Group, Hoboken, NJ, USA, 2Genesis Research Group, London, United Kingdom.
Presentation Documents
OBJECTIVES: Patients with type 2 diabetes mellitus (T2DM) experience substantial impact on health-related quality of life (HRQoL). Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly used in T2DM. As evidence on their impact on patient-reported outcomes (PROs) is emerging, we sought to synthesize these data via meta-analysis.
METHODS: ClinicalTrials.gov was searched to identify randomized controlled trials (RCTs) evaluating GLP-1 RAs in adults with T2DM. Trials were eligible for meta-analysis if they included a placebo comparator and reported PROs. For outcomes with sufficient data, random-effects meta-analyses were conducted using linear mixed-effects models with inverse-variance weighting to account for between-study variance. Heterogeneity was assessed using the I² statistic. Study-level estimates were stratified by dose and timepoint.
RESULTS: Fifty-eight RCTs were identified; 20 reported PROs. The DTSQ (n=13) and SF-36 (n=12) were the most frequently reported instruments. Only 4 RCTs (PIONEER 1, 4, 5, 8) reported sufficiently similar PRO data for inclusion in meta-analysis; all evaluated oral semaglutide versus placebo. At 6 months, DTSQ results were subject to high heterogeneity (I²=84%, n=3 studies). At 12 months, semaglutide 14 mg was associated with significant improvement in treatment satisfaction (mean difference: 2.28; 95% CI: 1.90 to 2.66; I²=0%; n=2 studies). For the SF-36 physical component summary (PCS), changes at 6 months were small and non-significant across doses. For the mental component summary (MCS), at 6 months, improvements were dose-dependent and statistically significant for higher doses of semaglutide.
CONCLUSIONS: Although meta-analyses were limited to a small subset of trials and not informed by a systematic literature review, the available evidence suggests oral semaglutide improves treatment satisfaction and mental health-related quality of life in adults with T2DM. Future research would benefit from standardized collection and reporting of PROs in GLP-1 RA trials to strengthen the evidence base for additional GLP-1s and allow for cross-treatment comparisons.
METHODS: ClinicalTrials.gov was searched to identify randomized controlled trials (RCTs) evaluating GLP-1 RAs in adults with T2DM. Trials were eligible for meta-analysis if they included a placebo comparator and reported PROs. For outcomes with sufficient data, random-effects meta-analyses were conducted using linear mixed-effects models with inverse-variance weighting to account for between-study variance. Heterogeneity was assessed using the I² statistic. Study-level estimates were stratified by dose and timepoint.
RESULTS: Fifty-eight RCTs were identified; 20 reported PROs. The DTSQ (n=13) and SF-36 (n=12) were the most frequently reported instruments. Only 4 RCTs (PIONEER 1, 4, 5, 8) reported sufficiently similar PRO data for inclusion in meta-analysis; all evaluated oral semaglutide versus placebo. At 6 months, DTSQ results were subject to high heterogeneity (I²=84%, n=3 studies). At 12 months, semaglutide 14 mg was associated with significant improvement in treatment satisfaction (mean difference: 2.28; 95% CI: 1.90 to 2.66; I²=0%; n=2 studies). For the SF-36 physical component summary (PCS), changes at 6 months were small and non-significant across doses. For the mental component summary (MCS), at 6 months, improvements were dose-dependent and statistically significant for higher doses of semaglutide.
CONCLUSIONS: Although meta-analyses were limited to a small subset of trials and not informed by a systematic literature review, the available evidence suggests oral semaglutide improves treatment satisfaction and mental health-related quality of life in adults with T2DM. Future research would benefit from standardized collection and reporting of PROs in GLP-1 RA trials to strengthen the evidence base for additional GLP-1s and allow for cross-treatment comparisons.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
PCR129
Topic
Methodological & Statistical Research, Patient-Centered Research, Study Approaches
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)