title: Safe and Effective Use of the Once Weekly Dulaglutide Single-Dose Pen in Injection-Naïve Patients With Type 2 Diabetes.
abstract: BACKGROUND
  This 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).
  
  
  METHODS
  Patients 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.
  
  
  RESULTS
  Among 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: International Diabetes Center, Minneapolis, MN, USA.
authors.forename: Glenn
authors.initials: G
authors.lastname: Matfin
authors.affiliation: Eli Lilly and Company, Windlesham, Surrey, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Van Brunt
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Alan G
authors.initials: AG
authors.lastname: Zimmermann
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Threlkeld
authors.affiliation: Eli Lilly and Company, Indianapolis, IN, USA ignaut_debra_a@lilly.com.
authors.forename: Debra A
authors.initials: DA
authors.lastname: Ignaut
mesh_terms: D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D004763:Glucagon-Like Peptides / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D007141:Immunoglobulin Fc Fragments / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D017060:Patient Satisfaction; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D007141:Immunoglobulin Fc Fragments; D011993:Recombinant Fusion Proteins; D004763:Glucagon-Like Peptides; C555680:dulaglutide
keywords: dulaglutide; self-injection; single-dose pen; type 2 diabetes