Tresiba

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

Consistent hypo reduction vs glargine U100 and glargine U300^*

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**

*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 only²²

RCT – Randomised Controlled Trial

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

* In glucose-lowering effect in patients with type 1 diabetes in a PK/PD study.

† Day-to-day variability in glucose-lowering effect during one dosing interval of 0-24 hours at steady state (AUC_GIR,τ,SS) is 20% for Tresiba^®.¹

AUC_GIR,τ,SS (area under the curve, glucose infusion rate, torque, steady state).

* Estimated treatment difference in HbA_1c -0.27%; (p=0.03).⁷

† Treatment with Tresiba^® was 27% less likely to result in treatment discontinuation than treatment with glargine U300 (HR, 0.73; p<0.001).⁷

CONFIRM was a retrospective real-world study in insulin-naïve patients.⁷

HR (hazard ratio).

Reducing insulin doses¹⁷
Skipping injections¹⁷
Avoiding physical exercise¹⁷

Although the fear of hypos is a barrier to insulin adherence for almost 9 out of 10 patients,¹⁵ 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.¹⁸

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

ǁ (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

‡ Cliniclly significant nocturnal (00:01-05:59 am) episodes, defined as ≥2 consecutive FGM readings at level 2 <3.0 mmol/L, separated by 15 minutes: 31.1 patients’ years of exposure vs 40.9 respectively (treatment rate ratio 0.76), 24% reduction.⁹

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

*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.^20,21

⁺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 only²²

RCT – Randomised Controlled Trial

EXPECT was a randomised, open-label, parallel-group, multicentre, multinational, treat-to-target, active-controlled trial. Participiants had an HbA_1c at screening <8.0% and had been receiving insulin treatment for >90 days. Participiants were pregnant from gestational week 8 to 14 or planning to become pregnant within 52 weeks. They recieved 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.

Heise T, Kaplan K, Haahr H. Day-to-Day and Within-Day Variability in Glucose-Lowering Effect Between Insulin Degludec and Insulin Glargine (100 U/mL and 300 U/mL): A Comparison Across Studies. Journal of Diabetes Science and Technology 2018; 12(2):356-363.

13.

Heise T, Nørskov M, Nosek L, Kaplan K, Famulla S, Haahr HL. Insulin degludec: Lower day-to-day and within-day variability in pharmacodynamic response compared with insulin glargine 300U/mL in type 1 diabetes. Diabetes, Obesity & Metabolism 2017: 19(7):1032-1039.

14.

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.

15.

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.

16.

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.

17.

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.

18.

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.

19.

Toujeo^® Summary of Product Characteristics, November 2021

20.

Levemir^® Summary of Product Characteristics, April 2021

21.

Levemir Prescribing Information Novo Nordisk, August 2022.

22.

American Diabetes Association. Management of Diabetes in Pregnancy: Standards of Medical Care in Diabetes – 2022. Diabetes Care 2022;45(Suppl. 1):S232–S243.

HQ22TSM00026, Date of preparation: September 2022

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

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