In 7 out of 7 trials vs insulin glargine U-100

Tresiba® successfully achieved noninferiority in A1C reduction1

(FDA-required primary endpoint)

TYPE 2 DIABETES

TYPE 1 DIABETES

Mean A1C Chart

COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4:

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%

Tresiba®: A1C reduction chart in Type 2 Diabetes patients

TYPE 2 DIABETES


COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4

Baseline: 8.2%
End of trial: 7.0%
Reduction: –1.15%


TYPE 2 DIABETES


COMPARATOR MEAN CHANGE FROM BASELINE

Insulin glargine U-100 + metformin ± DPP-4

Baseline: 8.2%
End of trial: 6.9%
Reduction: –1.22%


TYPE 1 DIABETES


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-100:
    • 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-100:
    • Study E, 0.04% (95% CI, –0.11%; 0.19%)
  • The prespecified noninferiority margin (0.4%) was met in all 7 clinical trials
  • A1C results were similar between Tresiba® and insulin glargine U-100 in the other 4 clinical trials


FPG reductions with Tresiba®1


TYPE 2 DIABETES

TYPE 1 DIABETES

FPG Chart

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

Tresiba®: A1C reduction chart in Type 2 Diabetes patients

TYPE 2 DIABETES


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


TYPE 2 DIABETES


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


TYPE 1 DIABETES


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
No clinically important differences in risk of hypoglycemia between Tresiba® and basal insulin comparators were observed in these clinical trials conducted in adult patients.


Percent of patients who experienced at least 1 episode of hypoglycemia1


Incidence rates in all type 2 diabetes adult trials (range)

  • 0% to 4.5% for severe hypoglycemiaa and 28.5% to 80.9% for Novo Nordisk–defined hypoglycemiab (± OADs or a basal-bolus regimen)

Incidence rates in all type 1 diabetes adult trials (range)

  • 10.4% to 12.7% for severe hypoglycemiaa and 93.0% to 99.4% for Novo Nordisk–defined hypoglycemiab (basal-bolus regimen)

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 D
Insulin-naïve adults with type 2 diabetes 52 week/U-100 pen1,2

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.

Mean end-of-trial basal insulin doses: Tresiba®, 56 units; insulin glargine U-100, 58 units.

Study E
Insulin-naïve adults with type 2 diabetes 26 week/U-200 pen1,3

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.

Mean end-of-trial basal insulin doses: Tresiba®, 59 units; insulin glargine U-100, 62 units.

Study A
Adults with type 1 diabetes 52 week/U-100 pen1,4

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 SMPG concentrations of 70 to 90 mg/dL.

Primary endpoint: Change in A1C from baseline after 52 weeks of treatment.

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.



Doctor Edelman Video

Find out what endocrinologist Dr Steven Edelman looks for when prescribing a basal insulin

Dive deeper into Tresiba®


Give patients a glucose-lowering effect of at least 42 hours1,c

View the mechanism of protraction video to see how Tresiba® works

Adult patients who miss a dose of Tresiba® should inject their daily dose during waking hours upon discovering the missed dose, then continue with their regular dosing schedule. Ensure that at least 8 hours have elapsed between Tresiba® injections.1    

cAfter the last of 8 once-daily injections (0.4 units/kg).

Selected Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens
  • Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening

Indications and Usage

Tresiba® (insulin degludec injection) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis or for pediatric patients requiring less than 5 units of Tresiba®.

Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen Between Patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens
  • Monitor blood glucose in all patients treated with insulin. Changes in insulin may affect glycemic control. These changes should be made cautiously and under medical supervision. Adjustments in concomitant oral anti-diabetic treatment may be needed
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors, always instruct patients to check the insulin label before each injection
  • Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Tresiba®
  • As with all insulins, Tresiba® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Tresiba®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered

Adverse Reactions

  • Adverse reactions commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain

Drug Interactions

  • Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose. The signs and symptoms of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine)

Please click here for Prescribing Information.

 

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2016.
  2. Zinman B, Philis-Tsimikas A, Cariou B, et al; on behalf of the NN1250-3579 (BEGIN ONCE LONG) Trial Investigators. Diabetes Care. 2012;35(12):2464-2471.
  3. Gough SCL, Bhargava A, Jain R, Mersebach H, Rasmussen S, Bergenstal RM. Diabetes Care. 2013;36(9):2536-2542.
  4. Heller S, Buse J, Fisher M, et al; on behalf of the BEGIN Basal-Bolus Type 1 Trial Investigators. Lancet. 2012;379(9825):1489-1497.