TRESIBA - Insulin glargine U-100
 0.04 [-0.11;0.19]
 
Proportion Achieving HbA1c < 7% at Trial End
 52.2%
 55.9%
 
FPG (mg/dL)
 
Baseline
 172
 174
 
End of trial
 106
 113
 
Adjusted mean change from baseline
 -71.1
 -63.5
 
Daily insulin dose
 
Baseline mean
 10 U
 10 U
 
Mean dose after 26 weeks
 59 U
 62 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 E, there were 12.3% of subjects in the TRESIBA and 12.7% Insulin glargine arms for whom data was missing at the time of the HbA1c measurement.

Study F: TRESIBA Administered at the Same Time each Day in Insulin Naïve Patients as an Add-on to One or More of the Following Oral Agents: Metformin, Sulfonylurea, Glinides or Alpha-Glucosidase inhibitors

The efficacy of TRESIBA was eva luated in a 26-week randomized, open-label, multicenter trial in Asia in 435 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 once-daily in the evening or insulin glargine U-100 once-daily according to the approved labeling. Pre-trial oral antidiabetes agents were continued as background therapy except for DPP-4 inhibitors or thiazolidinediones in both treatment arms.

The mean age of the trial population was 58.6 years and mean duration of diabetes was 11.6 years. 53.6% were male. All patients were Asian. 10.9% of patients had eGFR<60 mL/min/1.73m2. The mean BMI was approximately 25.0 kg/m2.

At week 26, the difference in HbA1c reduction from baseline between TRESIBA and insulin glargine U-100 was 0.11% with a 95% confidence interval of [-0.03%; 0.24%] and met the pre-specified non-inferiority margin (0.4%). See Table 10.

Table 10: Results at Week 26 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
 289
 146
 
HbA1c (%)
 
Baseline
 8.4
 8.5
 
End of trial
 7.2
 7.1
 
Adjusted mean change from baseline**
 -1.42
 -1.52
 
Estimated treatment difference [95%CI]

TRESIBA - Insulin glargine U-100
 0.11 [-0.03 ; 0.24]
 
Proportion Achieving HbA1c < 7% at Trial End
 40.8%
 48.6%
 
FPG (mg/dL)
 
Baseline
 152
 156
 
End of trial
 100
 102
 
Adjusted mean change from baseline
 -54.6
 -53.0
 
Daily insulin dose
 
Baseline mean (starting dose)
 9 U
 9 U
 
Mean dose after 26 weeks
 19 U
 24 U
 
*OAD: oral antidiabetic agent

**The change from baseline to end of treatment visit in HbA1c was analysed using ANOVA with trea