Tresiba

The Summary of Product Characteristics (SmPC) is based on the EU SmPC as of January 2022. Registration conditions differ internationally.
Always refer to the full local SmPC before prescribing. Tresiba^® is registered in the EU, Switzerland, USA, and Canada.

Flat and stable glucose-lowering effect with an ultra-long duration of action beyond 42 hours

Consistent hypo reduction vs glargine U100^*

Increase in Time in Range vs glargine U100 in patients with type 2 diabetes

The Tresiba^® label now includes controlled clinical trial data on its use in pregnant women with diabetes^+1**

Available with reusable smart insulin pens that integrate with CGM apps^*

Accompanied by the basal insulin titration app, Dose Check

*In a real world setting⁷

**As per ADA Standards of Medical Care for Management of Diabetes in Pregnancy - 2022: Insulins studied in RCTs are preferred over those studied in cohort studies, which are preferred over those studied in case reports only¹⁷

RCT – Randomised Controlled Trial

After injection, insulin degludec molecule bind to form chains^1-3

Individual molecules are then slowly and consistently released into the circulation^1-3

Mean glucose profile in a 42-hour clamp study in adults with type 1 diabetes (n=66)³

Example patient injection routine.

*Establishing a routine is important; Tresiba^® should be dosed once daily, with a minimum of 8 hours between doses.¹

Reducing insulin doses¹⁵
Skipping injections¹⁵
Avoiding physical exercise¹⁵

Although the fear of hypos is a barrier to insulin adherence for almost 9 out of 10 patients,¹³ it is possible to achieve good control with a low risk of hypoglycaemia.^5,6

Indeed, when it is time to consider insulin for a patient with type 2 diabetes, the consensus of the ADA and the EASD is to choose a basal insulin with a low risk of hypoglycaemia.¹⁶

Download consensus report

See BEGIN clinical trial

See SWITCH 2 clinical trial

See DEVOTE clinical trial

See CONFIRM* clinical trial

See REFLECT* clinical trial

^*Real-world evidence studies.
^†(p=0.002).⁴
Data from the extension trial set.⁴
In the BEGIN Once long trial, in insulin-naïve patients with type 2 diabetes, confirmed hypoglycaemic episodes included either episodes confirmed by self-monitored blood glucose corresponding to plasma glucose value <3.1 mmol/L (<56 mg/dL) or severe episodes requiring assistance. Episodes occurring between 00:01 and 05:59 (both inclusive) were classified as nocturnal.⁴
^‡(p<0.001). Maintenance period.⁵
In the SWITCH 2 trial, in patients with type 2 diabetes, overall hypoglycaemia was defined as severe or BG-confirmed (<3.1 mmol/L [<56 mg/dL]) with symptoms, and severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions, neurological recovery following the return of plasma glucose to normal, or both (ADA definition).⁵
^§(p<0.001).⁶
In the DEVOTE trial, in patients with type 2 diabetes at high risk of CV events, severe hypoglycaemic episodes were independently adjudicated using the ADA definition.⁶
^¶(p<0.05).⁷
CONFIRM was a retrospective real-world study.⁷
In the CONFIRM study, in insulin-naïve patients with type 2 diabetes, hypoglycaemia was recorded by the treating clinician and defined according to International Classification of Diseases codes 9 and 10.⁷
^ll(p<0.001).⁸
ReFLeCT was a prospective real-world study.⁸
In the ReFleCT study, in patients with type 2 diabetes, overall hypoglycaemia was defined as any event recorded as hypoglycaemia in patients’ diaries irrespective of symptoms, blood glucose or time of day.⁸

ADA (American Diabetes Association). BG (blood glucose). CV (cardiovascular).

* Insulin-treated patients with type 2 diabetes at increased risk of hypoglycaemia, p=0.03.⁹

† Mean TiR was 72.11% Tresiba^® vs 70.68% glargine U100, p=0.03.⁹

FGM (flash glucose monitoring). TiR (Time in Range).

· Dose Check is an app that provides daily dose guidance^* and only requires a smartphone to use¹⁸

· Dose Check requires patients to follow just two daily steps – logging blood glucose and then injecting the recommended dose¹⁸

· Dose Check calculates the insulin dose for your patients to help them reach their target blood glucose levels^18-20†

· Dose Check guides your patients to adjust their insulin to find their recommended dose^18,20,21‡

· Dose Check may reassure patients in knowing they’re taking the right insulin dose for them^22,23

Your patients can follow their progress through their dosing and blood glucose records with clear and simple charts and visuals. You can monitor your patients’ progress in managing their diabetes too.¹⁸

NovoPen^®6 or NovoPen Echo^® Plus in combination with a compatible app^*…

Allows patients to engage with treatment and has the potential for better outcomes^{24, 29-31†}

Removes the need for a manual insulin diary^24,29

May help patients avoid missing a dose or taking insulin doses too close together^‡

Facilitates personalising patients’ insulin management based on individual
injection data^{24, 29-31}

^*FreeStyle LibreLink and LibreView, Glooko^® and mySugr^®. NovoPen^® 6 and NovoPen Echo^® Plus are currently compatible Dexcom^® products through the integration by Glooko^®.
^†By providing reliable insulin dosing information.
^‡By seeing insulin doses and their glucose impact.

FreeStyle LibreLink^® and LibreView allow you and your patients to identify patterns in insulin and glucose data, enabling informed dose adjustments.

With Glooko^®, combined insulin and glucose reports may help you identify patterns and trends at a glance.

Dexcom^® with Glooko^® integration allows you to remotely monitor patients’ blood glucose levels and insulin doses^* and access a detailed view to make more informed treatment decisions

With mySugr^® and Accu-Chek^® Smart Pix, insulin data
from NovoPen^® 6 and NovoPen Echo^® Plus can be viewed alongside glucose data to identify patterns and trends

_{^*Remote monitoring is not a substitute for HCPs’ medical advice.}

*Levemir^® (insulin detemir) in combination with NovoRapid^® (insulin aspart) is a well-established treatment that has been widely used in clinical practice and is indicated for use during pregnancy.^36,37

⁺As per, ADA Standards of Medical Care in Diabetes - 2022: Management of Diabetes in Pregnancy: Insulins studied in RCTs are preferred over those studied in cohort studies, which are preferred over those studied in case reports only¹⁷

RCT – Randomised Controlled Trial

EXPECT was a randomised, open-label, parallel-group, multicentre, multinational, treat-to-target, active-controlled trial. Participants had an HbA_1c at screening ≤8.0% and had been receiving insulin treatment for ≥90 days. Participants were pregnant from gestational week 8 to 14 or planning to become pregnant within 52 weeks. They received Tresiba^® once daily or insulin detemir once/twice daily, both with insulin aspart 2-4 times daily with meals.¹⁰

Tresiba^® (Summary of Product Characteristics). Bagsværd, Denmark: Novo Nordisk A/S; January 2022. 

Vora J, Heise T. Variability of glucose-lowering effect as a limiting factor in optimizing basal insulin therapy: a review. Diabetes, Obesity & Metabolism 2013; 15(8):701-712. 

Haahr H, Heise T. A Review of the Pharmacological Properties of Insulin Degludec and Their Clinical Relevance. Clinical Pharmacokinetics 2014; 53(9):787-800.

Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis-Tsimikas A, Skjøth TV, Rana A, Mathieu C on behalf of the BEGIN Once Long Trial Investigators. Comparison of insulin degludec with insulin glargine in insulin-naive subjects with Type 2 diabetes: a 2-year randomized, treat-to-target trial. Diabetic Medicine 2013; 30(11):1298-1304.

Wysham C, Bhargava A, Chaykin L, de la Rosa R, Handelsman Y, Troelsen L, Kvist K, Norwood P. Effect of insulin degludec vs insulin glargine U100 on hypoglycemia in patients with type 2 diabetes: The SWITCH 2 Randomized Clinical Trial. JAMA 2017; 318(1):45-56. 

Marso SP, McGuire DK, Zinman B, Poulter NR, Emerson SS, Pieber TR, Pratley RE, Haahr P-M, Lange M, Brown-Frandsen K, Moses A, Skibsted S, Kvist K, Buse JB for the DEVOTE Study Group. Efficacy and safety of degludec versus glargine in type 2 diabetes. New England Journal of Medicine 2017; 377(8):723-732.

Tibaldi J, Hadley-Brown M, Liebl A, Haldrup S, Sandberg V, Wolden ML, Rodbard HW. A comparative effectiveness study of degludec and insulin glargine 300 U/mL in insulin-naïve patients with type 2 diabetes. Diabetes, Obesity and Metabolism 2019; 21:1001-1009.

Fadini GP, Feher M, Hansen TK, de Valk HW, Koefoed MM, Wolden M, Zimmermann E, Jendle J. Switching to degludec from other basal insulins is associated with reduced hypoglycemia rates: a prospective study. Journal of Clinical Endocrinology and Metabolism 2019; 104(12):5977-5990.

Goldenberg RM, Aroda VR, Billings LK, Christiansen ASL, Donatsky AM, Rizi EP, Podgorski G, Raslova K, Klonoff DC, Bergenstal RM. Effect of insulin degludec versus insulin glargine U100 on time in range: SWITCH PRO, a crossover study of basal insulin-treated adults with type 2 diabetes and risk factors for hypoglycaemia. Diabetes, Obesity and Metabolism 2021. doi: 10.1111/dom.14504.

10.

 Mathiesen ER et al. Maternal efficacy, safety, and pregnancy outcomes with degludec versus detemir in the treatment of pregnant women with type 1 diabetes: an international, multicentre, randomised trial. Presented at the European Association for the Study of Diabetes 57th Annual Meeting, 27 September-1 October 2021, Virtual Meeting.

11.

Vora J, Cariou B, Evans M, Gross JL, Harris S, Landstedt-Hallin L, Mithal A, Rodriguez MR, Meneghini L. Clinical use of insulin degludec. Diabetes Research and Clinical Practice 2015; 109(1):19-31.

12.

 Curtis B, Lage MJ. Glycemic control among patients with type 2 diabetes who initiate basal insulin: a retrospective cohort study. Journal of Medical Economics 2014; 17(1):21-31.

13.

Farsaei S, Radfar M, Heydari Z, Abbasi F, Qorbani M. Insulin adherence in patients with diabetes: risk factors for injection omission. Primary Care Diabetes. 2014; 8(4):338-345. 

14.

Khunti K, Alsifri S, Aronson R, Cigrovski Berkovic´ M, Enters-Weijnen C, Forsén T, Galstyan G, Geelhoed-Duljvestijn P, Goldfracht M, Gydesen H, Kapur R, Lalic N, Ludvik B, Moberg E, Pedersen-Bjergaard U, Ramachandran A on behalf of the HAT Investigator Group. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes, Obesity & Metabolism 2016; 18(9):907-915.

15.

Khunti K, Alsifri S, Aronson R, Cigrovski Berkovic´ M, Enters-Weijnen C, Forsén T, Galstyan G, Geelhoed-Duljvestijn P, Goldfracht M, Gydesen H, Kapur R, Lalic N, Ludvik B, Moberg E, Pedersen-Bjergaard U, Ramachandran A on behalf of the HAT Investigator Group. Impact of hypoglycaemia on patient-reported outcomes from a global, 24-country study of 27,585 people with type 1 and insulin-treated type 2 diabetes. Diabetes Research and Clinical Practice 2017; 130:121-129. 

16.

Buse JB, Wexler DJ, Tsapas A, Rossing P, Mingrone G, Mathieu C, D'Alessio DA, Davies MJ. 2019 update to: Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2020; 63(2):221-228. doi: 10.1007/s00125-019-05039-w. 

17.

American Diabetes Association. Management of diabetes in pregnancy: standards of care in diabetes-2024. Diabetes Care 47, S1 (2024): S282-S294.

18.

Data on file: Technical Specification Document & Device Description (DDSC-1) Amalgam Guide. 

19.

Dose Check Evidence Based Titration Protocols – Reference Document. 

20.

CER-001 – iSage Rx Clinical Evaluation Report Rev.13. 

21.

Grdinovac K, Robbins DC, Lavenbarg TA, Levin P, Sysko R. iSage: Successful Basal Insulin Titration Managed by a Prescription-Only Digital Therapy for T2DM. Diabetes 2019; 68:122-LB. 

22.

Vangoitsenhoven R, Van der Schueren B. Basal insulin titration by the app. The Lancet Regional Health – Europe 2023; 33:100720. 

23.

Cui L, Schroeder PR, Sack PA. Inpatient and Outpatient Technologies to Assist in the Management of Insulin Dosing. Clinical Diabetes 2020; 38(5):462-473. 

24.

Klonoff DC, Kerr D. Smart Pens Will Improve Insulin Therapy. Journal of Diabetes Science and Technology 2018; 12(3):551–553. 

25.

UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352(9131):837–53. 

26.

The Diabetes Control and Complications Trial Research Group. The relationship of glycemic exposure (HbA1c) to the risk of development and progression of retinopathy in the diabetes control and complications trial. Diabetes 1995; 44(8):968–83. 

27.

Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. British Medical Journal 2000; 321(7258):405–12. 

28.

Russell-Jones D, Pouwer F, Khunti K. Identification of barriers to insulin therapy and approaches to overcoming them. Diabetes, Obesity & Metabolism 2018; 20(3):488–496. 

29.

Data on File. NovoPen^® 6 Design Specification/Verification Report 

30.

Kalergis M, Nadeau J, Pacaud D, Yared Z, Yale J-F. Accuracy and Reliability of Reporting Self-monitoring of Blood Glucose Results in Adults With Type 1 and Type 2 Diabetes. Canadian Journal of Diabetes 2006;30(3):241-247. 

31.

Adolfsson P, Hartvig NV, Kaas A, Møller JB, Hellman J. Increased Time in Range and fewer missed bolus injections after introduction of a smart connected insulin pen. Diabetes Technology & Therapeutics 2020; 22(10):709–718. 

32.

FlexTouch^® incl. API and needle, product carbon footprint, Novo Nordisk, Corporate Environmental Strategy, version 3.1, September 2021 (rev. 2023). 

33.

NovoPen^® 5 / NovoPen^® 6 incl. Penfill^® and needle, product carbon footpront, Novo Nordisk, Corporate Environmental Strategy, version 3.1, September 2021 (rev. 2023). 

34.

NovoPen Echo^® / NovoPen Echo^® plus incl. Penfill^® and needle, product carbon footprint, Novo Nordisk, Corporate Environmental Strategy, version 3.1, September 2021 (rev. 2023) 

35.

Toujeo^® Summary of Product Characteristics, November 2021 

36.

Levemir^® Summary of Product Characteristics, April 2021 

37.

Levemir Prescribing Information Novo Nordisk, August 2022.

FlexTouch^®, NovoFine^®, NovoTwist^®, Penfill^®, NovoPen^® 6, and Tresiba^® are registered trademarks of Novo Nordisk A/S.

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HQ24TSM00014, July 2024

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