Trial reportJournal of diabetes science and technology2015
Safe and Effective Use of the Once Weekly Dulaglutide Single-Dose Pen in Injection-Naïve Patients With Type 2 Diabetes.
Trial report in Journal of diabetes science and technology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed.
- Comparison of the injection-site experience of the starting doses with semaglutide and dulaglutide: A randomized, double-blind trial in healthy subjects.Diabetes, obesity & metabolism · 2021 · on this mapTrial
- Glucagon-Like Peptide-1 Receptor Agonist Use in People Living with Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Narrative Review of the Key Evidence with Practical Considerations.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022Review
- Development of a Measure to Assess Attitudes Towards Nasal versus Autoinjector Glucagon Delivery Devices for Treatment of Severe Hypoglycemia.Diabetes, metabolic syndrome and obesity : targets and therapy · 2022Article
- Semaglutide single-dose pen-injector: Post hoc analysis of summative usability testing for weight management.Diabetes, obesity & metabolism · 2021Article
- Patient Perceptions of and Preferences Between Characteristics of Injectable Diabetes Treatments.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021Article
- Switching between GLP-1 receptor agonists in clinical practice: Expert consensus and practical guidance.International journal of clinical practice · 2021Article
- User-Centric Approach to Specifying Technical Attributes of Drug Delivery Devices: Empirical Study of Autoinjector-Cap Removal Forces.Patient preference and adherence · 2021Article
- Efficacy of Dulaglutide as a First Injectable Option for Patients with Type 2 Diabetes: A Post-Hoc Pooled Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Article
- Consensus Recommendations on GLP-1 RA Use in the Management of Type 2 Diabetes Mellitus: South Asian Task Force.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Review
- GLP-1 Receptor Agonists for Type 2 Diabetes and Their Role in Primary Care: An Australian Perspective.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Review
- A Review of Practical Issues on the Use of Glucagon-Like Peptide-1 Receptor Agonists for the Management of Type 2 Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Review
- Clinical and economic outcomes among injection-naïve patients with type 2 diabetes initiating dulaglutide compared with basal insulin in a US real-world setting: the DISPEL Study.BMJ open diabetes research & care · 2019Observational
- From drug-delivery device to disease management tool: a study of preferences for enhanced features in next-generation self-injection devices.Patient preference and adherence · 2019Article
- Adherence to antihyperglycemic medications and glucagon-like peptide 1-receptor agonists in type 2 diabetes: clinical consequences and strategies for improvement.Patient preference and adherence · 2018Review
- Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years.Diabetes, obesity & metabolism · 2016Article
- Mode of administration of dulaglutide: implications for treatment adherence.Patient preference and adherence · 2016Review
- Advances in the treatment of type 2 diabetes: impact of dulaglutide.Diabetes, metabolic syndrome and obesity : targets and therapy · 2016Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis 4-week, phase 3b, multicenter, open-label, single-arm, outpatient study demonstrated the safe and effective use of the dulaglutide single-dose pen containing 0.5 mL of placebo for subcutaneous injection in injection-naïve adult patients with type 2 diabetes (T2D), with A1C ≤ 8.5% (69 mmol/mol), BMI ≥ 23 kg/m2 and ≤ 45 kg/m(2).
methodPatients completed a modified self-injecting subscale of the Diabetes Fear of Injecting and Self-Testing Questionnaire (mD-FISQ) and were trained to self-inject with the single-dose pen. Patients completed the initial self-injection at the site, injected at home for 2 subsequent weeks, and returned to the site for the final injection. The initial and final self-injections were evaluated for success; the final (initial) self-injection success rate was the primary (secondary) outcome measure, and the primary (secondary) objective was to demonstrate this success rate as being significantly greater than 80%. Patients recorded their level of pain after each injection. After the final injection, patients completed the mD-FISQ and the Medication Delivery Device Assessment Battery (MDDAB) to assess their perceptions of the single-dose pen, including ease of use and experience with the device.
resultsAmong 211 patients (mean age: 61 years), the primary objective was met, with a final injection success rate of 99.1% (95% CI: 96.6% to 99.7%). Among 214 patients, the initial injection success rate was 97.2% (95% CI: 94.0% to 98.7%), meeting the key secondary objective. Overall, most patients (>96%) found the device easy to use, were satisfied with the device, and would be willing to continue to use the single-dose pen after the study. There was a significant reduction (P < .001) from baseline to study end in patients' fear of self-injecting, as measured by the mD-FISQ.
conclusionsThe dulaglutide single-dose pen was found to be a safe and effective device for use by patients with T2D who were injection-naïve. A positive injection experience is an important factor for patients and providers when initiating injectable therapy.
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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.