The efficacy of TRESIBA was eva luated in a 26-week randomized, open-label, multicenter trial in 447 patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agent (OADs) at baseline. Patients were randomized to TRESIBA once-daily at any time of day or sitagliptin once-daily according to the approved labeling. One or two of the following oral antidiabetes agents (metformin, sulfonylurea or pioglitazone) were also administered in both treatment arms.

The mean age of the trial population was 55.7 years and mean duration of diabetes was 7.7 years. 58.6% were male. 61.3% were White, 7.6% Black or African American. 21.0% were Hispanic. 6% of patients had eGFR<60 mL/min/1.73m2. The mean BMI was approximately 30.4 kg/m2.

At the end of 26 weeks, TRESIBA provided greater reduction in mean HbA1c compared to sitagliptin (p < 0.001). See Table 13.

Table 13: Results at Week 26 in a Trial Comparing TRESIBA to Sitagliptin in Patients with Type 2 Diabetes Mellitus on OADs*

 TRESIBA + OAD(s)*
 Sitagliptin + OAD(s)*
 
N
 225
 222
 
HbA1c (%)
 
Baseline
 8.8
 9.0
 
End of trial
 7.2
 7.7
 
Adjusted mean change from baseline**
 -1.52
 -1.09
 
Estimated treatment difference [95%CI]

TRESIBA - Sitagliptin
 -0.43 [-0.61;-0.24]1
 
Proportion Achieving HbA1c < 7% at Trial End
 40.9%
 27.9%
 
FPG (mg/dL)
 
Baseline
 170
 179
 
End of trial
 112
 154
 
Adjusted mean change from baseline
 -61.4
 -22.3
 
Daily insulin dose
 
Baseline mean
 10 U
 N/A
 
Mean dose after 26 weeks
 43 U
 N/A
 
*OAD: oral antidiabetic agent

**The change from baseline to end of treatment visit in HbA1c was analysed using ANOVA with treatment, region, sex, and anti-diabetic treatment at screening as fixed effects, and age and baseline HbA1c as covariates.

In Study I, there were 20.9% of subjects in the TRESIBA and 22.5% Sitagliptin arms for whom data was missing at the time of the HbA1c measurement.

1p <0.001; 1-sided p-value eva luated at 2.5% level for superiority

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How SuppliedTRESIBA is available as a clear and colorless solution in the following package sizes (see Table 14).

Table 14 Presentations of TRESIBA

TRESIBA
 Total volume
 Concentration
 Total units available in presentation
 NDC number
 Max dose per injection
 Dose increment
 Package Size
 
U-100 FlexTouch
 3 mL
 100 units/mL
 300 Units
 0169-2660-15
 80 Units
 1 Unit
 5 pens/pack
 
U-200 FlexTouch
 3 mL
 200 units/mL
 600 Units
 0169-2550-13
 160 Units
 2 Unit
 3 pens/pack
 

16.2 Recommended StorageUnused TRESIBA should be stored between 36°F to 46°F (2°C and 8°C). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use TRESIBA if it has