At week 52, the difference in HbA1c reduction from baseline between TRESIBA and insulin glargine U-100 was 0.09% with a 95% confidence interval of [-0.04%; 0.22%] and met the pre-specified non-inferiority margin (0.4%); See Table 8.

Table 8: Results at Week 52 in a Trial Comparing TRESIBA to Insulin glargine U-100 in Patients with Type 2 Diabetes Mellitus on OAD(s)*

 TRESIBA + OAD(s)*
 Insulin glargine U-100 + OAD(s)*
 
N
 773
 257
 
HbA1c (%)
 
Baseline
 8.2
 8.2
 
End of trial
 7.1
 7.0
 
Adjusted mean change from baseline**
 -1.06
 -1.15
 
Estimated treatment difference [95%CI]

TRESIBA - Insulin glargine U-100
 0.09 [-0.04;0.22]
 
Proportion Achieving HbA1c < 7% at Trial End
 51.7%
 54.1%
 
FPG (mg/dL)
 
Baseline
 174
 174
 
End of trial
 106
 115
 
Adjusted mean change from baseline
 -68.0
 -60.2
 
Daily insulin dose
 
Baseline mean (starting dose)
 10 U
 10 U
 
Mean dose after 52 weeks
 56 U
 58 U
 
*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 D, there were 20.6% of subjects in the TRESIBA and 22.2% Insulin glargine arms for whom data was missing at the time of the HbA1c measurement.

Study E: TRESIBA U-200 Administered at the Same Time each Day as an Add-on to Metformin with or without a DPP-4 inhibitor in Insulin Naïve Patients

The efficacy of TRESIBA U-200 was eva luated in a 26-week randomized, open-label, multicenter trial in 457 insulin naïve patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agents (OADs) at baseline. Patients were randomized to TRESIBA U-200 once-daily with the evening meal or insulin glargine U-100 once-daily according to the approved labeling. Both treatment arms were receiving metformin alone (84%) or in combination with a DPP-4 inhibitor (16%) as background therapy.

The mean age of the trial population was 57.5 years and mean duration of diabetes was 8.2 years. 53.2% were male. 78.3% were White, 13.8% Black or African American. 7.9% were Hispanic. 7.5% of patients had eGFR <60 mL/min/1.73m2. The mean BMI was approximately 32.4 kg/m2.

At week 26, the difference in HbA1c reduction from baseline between TRESIBA U-200 and insulin glargine U-100 was 0.04% with a 95% confidence interval of [-0.11%; 0.19%] and met the pre-specified non-inferiority margin (0.4%). See Table 9.

Table 9: Results at Week 26 in a Trial Comparing TRESIBA U-200 to Insulin glargine U-100 in Patients with Type 2 Diabetes Mellitus on OAD(s)*

 TRESIBA U-200 + Met ± DPP-4
 Insulin glargine U-100 + Met ± DPP-4
 
N
 228
 229
 
HbA1c (%)
 
Baseline
 8.3
 8.2
 
End of trial
 7.0
 6.9
&nb