Insulin glargine U-100 + metformin ± DPP-4
As demonstrated in the BEGIN clinical trial program
Tresiba® met A1C efficacy noninferiority endpoints in 7 out of 7 trials vs insulin glargine U-1001
ADULTS WITH T2D

ADULTS WITH T1D

COMPARATOR MEAN CHANGE FROM BASELINE
Insulin glargine U-100 + metformin ± DPP-4
Baseline: 8.2%
End of trial: 7.0%
Reduction: –1.15%
Baseline: 8.2%
End of trial: 6.9%
Reduction: –1.22%
Insulin glargine U-100 + insulin aspart
Baseline: 7.7%
End of trial: 7.3%
Reduction: –0.34%


ADULTS WITH T2D

COMPARATOR MEAN CHANGE FROM BASELINE
Insulin glargine U-100 + metformin ± DPP-4
Baseline: 8.2%
End of trial: 7.0%
Reduction: –1.15%
ADULTS WITH T2D

COMPARATOR MEAN CHANGE FROM BASELINE
Insulin glargine U-100 + metformin ± DPP-4
Baseline: 8.2%
End of trial: 6.9%
Reduction: –1.22%
ADULTS WITH T1D

COMPARATOR MEAN CHANGE FROM BASELINE
Insulin glargine U-100 + insulin aspart
Baseline: 7.7%
End of trial: 7.3%
Reduction: –0.34%
- At week 52, the difference in A1C reduction from baseline for Tresiba® and insulin glargine U-1001:
- Study D, 0.09% (95% CI, –0.04%; 0.22%)
- Study A, –0.01% (95% CI, –0.14%; 0.11%)
- At week 26, the difference in A1C reduction from baseline for Tresiba® U-200 and insulin glargine U-1001:
- Study E, 0.04% (95% CI, –0.11%; 0.19%)
- A1C results were similar between Tresiba® and insulin glargine U-100 in the other 4 clinical trials1
- The prespecified noninferiority margin (0.4%) was met in all 7 clinical trials1
FPG reductions with Tresiba®1
ADULTS WITH T2D

ADULTS WITH T1D

COMPARATOR MEAN CHANGE FROM BASELINE
Insulin glargine U-100 + metformin ± DPP-4
Insulin glargine U-100 + metformin ± DPP-4
Baseline: 174 mg/dL
End of trial: 115 mg/dL
Reduction: –60.2 mg/dL
Baseline: 174 mg/dL
End of trial: 113 mg/dL
Reduction: –63.5 mg/dL
Insulin glargine U-100 + insulin aspart
Baseline: 174 mg/dL
End of trial: 149 mg/dL
Reduction: –21.6 mg/dL

ADULTS WITH T2D

COMPARATOR MEAN CHANGE FROM BASELINE
Insulin glargine U-100 + metformin ± DPP-4
Baseline: 174 mg/dL
End of trial: 115 mg/dL
Reduction: –60.2 mg/dL
ADULTS WITH T2D

COMPARATOR MEAN CHANGE FROM BASELINE
Insulin glargine U-100 + metformin ± DPP-4
Baseline: 174 mg/dL
End of trial: 113 mg/dL
Reduction: –63.5 mg/dL
ADULTS WITH T1D

COMPARATOR MEAN CHANGE FROM BASELINE
Insulin glargine U-100 + insulin aspart
Baseline: 174 mg/dL
End of trial: 149 mg/dL
Reduction: –21.6 mg/dL
- FPG results were similar between Tresiba® and insulin glargine U-100 in the other 4 clinical trials
Additional efficacy endpoint in Studies D, E, and A: FPG reduction from baseline through week 26 (Study E) or week 52 (Studies D and A)2-4


In the BEGIN clinical trials
Hypoglycemia incidence rates were comparable among Tresiba® and other basal insulins1
Percentage of patients with type 1 diabetes who experienced at least 1 episode of severe Novo Nordisk–defined hypoglycemiaa,b
10.4% to 12.7% for severe hypoglycemiaa
93.0% to 99.4% for Novo Nordisk–defined hypoglycemiab (basal-bolus regimen)
Percentage of patients with type 2 diabetes who experienced at least 1 episode of severe Novo Nordisk–defined hypoglycemiaa,b
0% to 4.5% for severe hypoglycemiaa
28.5% to 80.9% for Novo Nordisk–defined hypoglycemiab (OADs and/or basal bolus)
aSevere hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
bNovo Nordisk–defined hypoglycemia: a severe hypoglycemia event or an event where laboratory or self-measured glucose calibrated to plasma was <56 mg/dL or where whole blood glucose was <50 mg/dL (ie, with or without the presence of hypoglycemic symptoms).
Study designs
Study D
Insulin-naïve adults with type 2 diabetes1,2
Patients randomized: Tresiba® (n=773); insulin glargine U-100 (n=257).
Study design: 52-week, randomized, open-label, multicenter trial comparing the efficacy and safety of once-daily Tresiba® U-100 and once-daily insulin glargine U-100, both with metformin with or without a DPP-4 inhibitor. Basal insulin was titrated weekly to an FPG target of 70 to 90 mg/dL according to mean prebreakfast self-measured blood glucose (SMBG) values (mean of 3 consecutive days).
Primary endpoint: Change in A1C from baseline after 52 weeks of treatment.
Other efficacy assessments: Change from baseline in FPG, SMBG, and A1C <7% responders.
Mean end-of-trial basal insulin doses: Tresiba®, 56 units; insulin glargine U-100, 58 units.
Study E
Insulin-naïve adults with type 2 diabetes1,3
Patients randomized: Tresiba® (n=228); insulin glargine U-100 (n=229).
Study design: 26-week, randomized, open-label, multicenter trial comparing the efficacy and safety of once-daily Tresiba® U-200 and once-daily insulin glargine U-100, both with metformin with or without a DPP-4 inhibitor. Basal insulin was titrated weekly to an FPG target of 70 to 90 mg/dL according to mean prebreakfast SMBG values (mean of 3 consecutive days).
Primary endpoint: Change in A1C from baseline after 26 weeks of treatment.
Secondary confirmatory endpoints: Number of treatment-emergent confirmed hypoglycemic episodes, change from baseline in FPG, within-subject variability as measured by coefficient of variation, and frequency of participants achieving A1C <7% without confirmed hypoglycemic episodes.
Mean end-of-trial basal insulin doses: Tresiba®, 59 units; insulin glargine U-100, 62 units.
Study A
Adults with type 1 diabetes1,4
Patients randomized: Tresiba® (n=472); insulin glargine U-100 (n=157).
Study design: 52-week, randomized, controlled, open-label, multinational, parallel design, treat-to-target, noninferiority trial comparing the efficacy and safety of once-daily Tresiba® U-100 and once-daily insulin glargine U-100. Insulin aspart was administered before each meal in both treatment arms. Basal insulin was titrated once weekly to an FPG target of 70 to 90 mg/dL according to mean prebreakfast SMBG values (mean of 3 consecutive days). Bolus insulin was titrated to preprandial and bedtime SMBG concentrations of 70 to 90 mg/dL.
Primary endpoint: Change in A1C from baseline after 52 weeks of treatment.
Secondary endpoints: FPG, SMBG, hypoglycemia, bodyweight, and lipids.
Mean end-of-trial basal and bolus insulin doses: Tresiba® arm: Tresiba®, 29 units; insulin aspart, 32 units; insulin glargine U-100 arm: insulin glargine U-100, 31 units; insulin aspart, 35 units.