Qualitative Exit Interviews to Characterize the Positive Treatment Experiences of Patients in the Phase III Trial of Orforglipron Versus Oral Semaglutide for the Treatment of Type 2 Diabetes.
Patients reported a mean reduction in glycated hemoglobin of 1.6% and a mean weight loss of 4.7 kg, expressing high satisfaction with the treatment.
Where it sits
this study against the rest of the orforglipron (ly-3502970) corpusSummary and findings
This study conducted qualitative exit interviews with patients who participated in the ACHIEVE-3 trial comparing Orforglipron and oral semaglutide for type 2 diabetes. Patients reported a mean reduction in glycated hemoglobin of 1.6% and a mean weight loss of 4.7 kg. All patients expressed satisfaction with the treatment and were likely to recommend it to others.
Abstract
<h4>Background and objective</h4>There is an unmet need for effective and well-tolerated oral formulations of glucagon-like peptide 1 receptor agonists for the management of type 2 diabetes. Orforglipron and oral semaglutide are two oral glucagon-like peptide 1 receptor agonists evaluated in the ACHIEVE-3 clinical trial (NCT06045221). These novel treatments have the means to achieve clinically meaningful glycemic control and weight reduction, which may result in substantial positive changes in patients' daily lives. The objective of this study was to conduct exit interviews following the ACHIEVE-3 trial to characterize positive treatment experiences and outcomes, beyond glycated hemoglobin and weight reduction, reported by patients living with type 2 diabetes who received oral glucagon-like peptide 1 receptor agonist-based treatments.<h4>Methods</h4>Qualitative interviews were conducted across ten clinical sites within the USA with patients who had enrolled in ACHIEVE-3 and completed at least 3 months of treatment. Interviews were conducted in English or Spanish, audio-recorded, and transcribed. Transcripts were analyzed to identify and categorize positive treatment benefits reported during the interviews. Descriptive statistics were used to characterize the sample.<h4>Results</h4>Sixty patients completed the qualitative exit interviews. Patients had a mean age of 59.1 years (standard deviation [SD] = 10.3), and almost half were female (n = 28, 46.7%). Patients had been diagnosed with type 2 diabetes for a mean of 8.5 years (SD = 5.7). By the end of the study, patients reduced their glycated hemoglobin by 1.6% (SD = 1.3) from a baseline of 8.3% and lost a mean of 4.7 kg (SD = 6.8) from a baseline of 96.0 kg. All patients reported being satisfied with the trial medication (n = 59/59), were likely to recommend the treatment to other patients, and all but one were willing to continue taking the medication. As expected, the two most important and most frequently reported positive changes were controlled glycated hemoglobin (n = 53, 88.3%) and weight reduction (n = 50, 83.3%). Other common spontaneously reported positive concepts included increased perceived energy (n = 28, 46.7%), reduced appetite and cravings (n = 23, 38.3%), improved exercise/movement (n = 18, 30.0%), and psychological improvements (n = 18, 30.0%). Additional positive changes included increased confidence/self-esteem, improved diet and eating habits, improved sleep, and improved or a lack of deterioration in vision. All reported positive changes were considered meaningful by patients.<h4>Conclusions</h4>The current study explored the positive experiences of patients taking an oral glucagon-like peptide 1 receptor agonist in the ACHIEVE-3 trial beyond traditional clinical benefits, such as glycemic control and weight reduction. The positive changes identified may be suitable targets for future clinical trial clinical outcome assessment endpoint strategies to help differentiate treatments and in clinical practices to classify patients' experiences.
Background
This paper addresses the need for effective oral formulations of glucagon-like peptide 1 receptor agonists for managing type 2 diabetes. Prior studies have primarily focused on clinical outcomes such as glycemic control and weight loss. Understanding patient-reported experiences can provide insights into treatment satisfaction and inform future clinical practices.
Methods
Qualitative interviews were conducted with 60 patients who completed at least 3 months of treatment in the ACHIEVE-3 trial across ten clinical sites in the USA. The interviews were audio-recorded and transcribed for analysis. Descriptive statistics characterized the sample demographics and treatment experiences.
Results
The primary endpoint indicated that patients reduced their glycated hemoglobin by 1.6% (SD = 1.3) from a baseline of 8.3%. Additionally, patients reported a mean weight loss of 4.7 kg (SD = 6.8) from a baseline of 96.0 kg. Satisfaction with the trial medication was reported by all but one patient.
Interpretation
The findings suggest that while the glycemic control and weight loss are statistically significant, the clinical significance of a 1.6% reduction in glycated hemoglobin and 4.7 kg weight loss should be evaluated in the context of individual patient goals. Limitations include the small sample size and reliance on self-reported data, which may not fully capture the treatment's effectiveness.
Key findings
- Mean age of participants was 59.1 years (SD = 10.3).
- Patients reduced glycated hemoglobin by 1.6% (SD = 1.3) from a baseline of 8.3%.
- Patients lost a mean of 4.7 kg (SD = 6.8) from a baseline of 96.0 kg.
- All patients reported satisfaction with the trial medication (n = 59/59).
- Controlled glycated hemoglobin was reported by 88.3% of patients (n = 53).
- Weight reduction was reported by 83.3% of patients (n = 50).
Limitations
- Qualitative data may introduce bias.
- Small sample size of 60 patients.
- Limited to patients who completed the trial.
- No long-term follow-up reported.