p-titrated on metformin, based on investigator discretion; this was followed by a 7-week glycemic stabilization period prior to randomization.
At randomization, patients discontinued their pre-study insulin regimen and were randomized to TRULICITY 0.75 mg once weekly, TRULICITY 1.5 mg once weekly, or insulin glargine once daily, all in combination with prandial insulin lispro 3 times daily, with or without metformin. Insulin lispro was titrated in each arm based on preprandial and bedtime glucose, and insulin glargine was titrated to a fasting plasma glucose goal of <100 mg/dL. Only 38% of patients randomized to glargine were titrated to the fasting glucose goal at the 26 week primary timepoint.
Patients had a mean age of 59 years; mean duration of type 2 diabetes of 13 years; 54% were male; race: White, Black and Asian were 79%, 10% and 4%, respectively; and 33% of the study population were in the US.
Treatment with TRULICITY 0.75 mg and 1.5 mg once weekly resulted in a reduction in HbA1c from baseline. The difference in observed effect size between TRULICITY 0.75 mg and 1.5 mg, respectively, and glargine in this trial excluded the pre-specified non-inferiority margin of 0.4%.
Table 7: Results at Week 26 of TRULICITY Compared to Insulin Glargine, Both in Combination with Insulin Lisproa
a Intent-to-treat population. Last observation carried forward (LOCF) was used to impute missing data. Data post-onset of rescue therapy are treated as missing. At Week 26, primary efficacy was imputed for 14%, 15%, and 14% of individuals randomized to TRULICITY 0.75 mg, TRULICITY 1.5 mg and glargine, respectively.
b Least-squares (LS) mean adjusted for baseline value and other stratification factors.
‡ Subjects included in the analysis are a subset of the ITT population that had at least one post-baseline assessment. The primary analysis included 275, 273 and 276 individuals randomized to TRULICITY 0.75 mg, TRULICITY 1.5 mg, and glargine, respectively.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Each TRULICITY single-dose pen or prefilled syringe is packaged in a cardboard outer carton.
Carton of 4 Single-Dose Pens
0.75 mg/0.5 mL solution in a single-dose pen (NDC 0002-1433-80)
1.5 mg/0.5 mL solution in a single-dose pen (NDC 0002-1434-80)
Carton of 4 Prefilled Syringes
0.75 mg/0.5 mL solution in a single-dose prefilled syringe (NDC 0002-1431-80)
1.5 mg/0.5 mL solution in a single-dose prefilled syringe (NDC 0002-1432-80)
16.2 Storage and Handling
Store TRULICITY in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not use TRULICITY beyond the expiration date.
If needed, each single-dose pen or prefilled syringe can be kept at room temperature, not to exceed 86°F (30°C) for a total of 14 days.
Do not freeze TRULICITY. Do not use TRULICITY if it has been frozen.
TRULICITY must be protected from light. Storage of TRULICITY in the original carton is recommended until time of administration.
Discard the TRULICITY single-dose pen or prefilled syringe after use in a puncture-resistant container.
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