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/m2. Method: 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.
Aim: To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro (Humalog ® ) in people with type 1 diabetes on continuous subcutaneous insulin infusion (CSII).Materials and Methods: This was a phase 3, 16-week, treat-to-target study in patients randomized to double-blind URLi (N = 215) or lispro (N = 217). The primary endpoint was change from baseline HbA1c (non-inferiority margin 4.4 mmol/mol [0.4%]), with multiplicity-adjusted objectives for postprandial glucose (PPG) levels during a meal test, and time spent in the target range 70-180 mg/dL (TIR).Results: URLi was non-inferior to lispro for change in HbA1c, with a least-squares mean (LSM) difference of 0.3 mmol/mol (95% confidence interval [CI] -0.6, 1.2) or 0.02%
Background: Ultra rapid lispro (URLi) is a new insulin lispro formulation that has accelerated absorption and improved postprandial glucose control compared with insulin lispro (Humalog Ò ). The compatibility and safety of URLi versus lispro were evaluated in patients with type 1 diabetes using continuous subcutaneous insulin infusion (insulin pump). Methods: In this phase 3, double-blind, crossover study, 49 patients were randomized to two 6-week treatment periods, after a 2-week lead-in period on lispro. The primary endpoint was the rate of infusion set failures due to a pump occlusion alarm, or unexplained hyperglycemia with blood glucose >13.9 mmol/L (250 mg/dL) that did not decrease within 1 h after a correction bolus. Results: There was no significant difference in the rate of infusion set failures between URLi and lispro (0.03 vs. 0.05 events/30 days, P = 0.375). A higher rate of premature infusion set changes was observed with URLi (1.13 vs. 0.78 events/30 days; P = 0.028), translating to one additional infusion set change approximately every 3 months. A trend toward improved glycemic control was observed with URLi treatment: Time in range 3.9-10.0 mmol/L (71-180 mg/dL) was 65.7% -1.3% versus 63.0% -1.3%. Treatment-emergent adverse events (TEAEs) were reported by 46.9% of patients on URLi treatment and 18.8% on lispro. This difference was driven by an increase in infusion site reactions-more than 90% were mild. Incidence of all other TEAEs and severe hypoglycemia was similar between treatments. Conclusions: URLi was compatible with insulin pump use with a safety profile similar to lispro.
Glide force, average glide force, and glide force variability of the insulin lispro 200 units/mL pen (Eli Lilly and Company, Indianapolis, IN, USA) were compared to the Humalog KwikPen 100 units/mL pen (hereafter, KwikPen; Eli Lilly and Company, Indianapolis, IN, USA). Data were collected on 2 doses, 2 injection speeds, and 2 needle types. Insulin lispro 200 units/mL pen showed significantly lower maximum glide force, average glide force, and glide force variability than the KwikPen across all combinations of dose size, dose speed, and needle type. The lower glide force observed with the insulin lispro 200 units/mL pen offers another treatment option for patients with type 1 or type 2 diabetes who require greater than 20 units of mealtime insulin daily.
Background: Automated insulin delivery systems are associated with improved glycemic outcomes for patients with diabetes. Ultra rapid lispro (URLi), which has an accelerated pharmacokinetic profile and shows superior postprandial glucose control compared to lispro (Humalog ® ), is a potential candidate for use in these systems. Methods:In this double-blind, crossover trial over two 4-week treatment periods, we evaluated URLi in a hybrid closed-loop system using the Medtronic MiniMed TM 670G system (670G). After a 2-week lead-in on lispro, 42 adults with type 1 diabetes were randomized to 1 of 2 treatment sequences of URLi and lispro delivered via the 670G.Primary endpoint was the percentage of time with glucose values within target range 3.9-10.0 mmol/L (70-180 mg/dL; %TIR).Results: Both treatments achieved %TIR over the 24-hour period that was above the 70% minimum recommended by the International Consensus Guidance: URLi, 77.0%; lispro, 77.8%; p=0.339. %Time <3.0 mmol/L (54 mg/dL) was similar between treatments (URLi, 0.3%; lispro, 0.4%; p=0.548) and %time <3.9 mmol/L (70 mg/dL) was lower with URLi (1.5%) vs. lispro (2.2%); p=0.009 while %time >10.0 mmol/L (180 mg/dL) was higher with URLi (21.5% [309.4 min] vs. 19.9% [287.2 min]; p=0.088). Mean sensor glucose was
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