Type 2 Diabetes

Why are we not using this fantastic drug called communication more often?

Dr Auus Alzaid emphasises the need for progressive training and clinician responsibility to ensure that the power of communication is used to maximum advantage.

Ten recommendations to communicate better for successful outcome

Find recommendations for effective communication, with specific reference to clinical practice. As one example, how can clinicians encourage patients to engage with self-reflection? Evidence demonstrates that a patient-centric approach is key to adding benefit.

Physician barriers to treatment intensification

Do you know the relationship between medication prescribed, filled at pharmacy, initially taken, and long-term adherence? There are also many reasons why physicians fail to adequately intensify treatment when needed. Dr Helmut Brath highlights why it may be time to do more.

Reasons why patients find it difficult to comply

Do physicians present an overwhelmingly negative impression of the reality of type 2 diabetes, and what impact does this have on patient behaviour? Patient guilt, embarrassment, inadequate understanding, and fear are just some of the challenges associated with ineffective support.

Goal of patient management

Dr Brath presents a roadmap to effective management of type 2 diabetes, positioning the physician as a facilitator to achieve individualised care, keeping in mind many important patient factors.

Clinical inertia and treatment intensification - Matthias Blüher

Join Professor Matthias Blüher at the Novartis virtual symposium at the EASD (European Association for the Study of Diabetes) 2020. Matthias highlights the paradigmatic shift in how type 2 diabetes treatment has changed over the past one-hundred years, but also some remaining barriers in achieving complete control over the disease.

VERIFY design and insights

Disease progression: β-cell function and insulin sensitivity

Is disease progression in type 2 diabetes (T2DM) predictable? Regardless of intervention, data show that progressive loss of β-cell function and insulin sensitivity is a reality.

β-cell activity and treatment response in treatment-naïve patients

Explore results from the VERIFY study in this presentation with Professor David Matthews. Understand how homeostasis index HOMA-B may enable more personalised treatment when used to identify those at greater risk of treatment failure.

Early versus late intensification: learnings from landmark studies and rationale for the VERIFY study

What effect do interventions and treatments have on disease progression in T2DM? The importance of using optimal first line therapy, lifestyle interventions, timely treatment intensification and undertaking regular review to avoid clinical inertia is underpinned by the evidence presented.

VERIFY: design and baseline characteristics

VERIFY, a multinational and multi-ethnic study that explores combining glucose-lowering therapy, is introduced by Professor David Matthews, who provides insight into baseline characteristics of randomised participants in the early combination and initial monotherapy groups.

VERIFY: outcomes

Professor Matthews presents the VERIFY study in relation to the primary outcome of the trial: time to treatment failure. He demonstrates how the secondary outcome of time to second failure and insulin initiation addresses the question of additional benefit from initial combined therapy instead of a sequential additive strategy.

Figure 1. Key questions from the VERIFY study.

Do those with T2DM benefit from having combined therapy at the beginning of their pharmacological management?

What is the clinical interpretation of the VERIFY results? Professor Stefano Del Prato talks to the primary outcome of the VERIFY study.

Do those with T2DM benefit more from having combined therapy at the beginning of their pharmacological management compared to sequential approach?

Professor Del Prato examines the two distinct strategies and the synergistic effect of drugs with different pathophysiological mechanisms of action in relation to achieving a durable treatment effect. The 5 year VERIFY study results impacted updates to guidelines for combination treatment.

VERIFY outcomes

VERIFY: does it matter?

How does the VERIFY study add to understanding the risk of micro and macrovascular complications in relation to glycaemic control?

VERIFY: strengths and limitations

The relevance of the VERIFY study is discussed in relation to its strengths; reproducibility is key. Looking at study limitations may also help apply key findings to clinical practice. The VERIFY study key takeaways are emphasised here.

Patient selection for early combination strategy

Did the VERIFY study demonstrate evidence for selecting distinct patient populations for combination therapy, and might clinical inertia exist in relation to implementing study results?

Are there any prerequisites to starting early combination therapy?

Starting combination therapy is discussed in the context of β-cell disfunction, with a focus on the question of further stratifying patients in relation to β-cell secretory function or sensitivity.

Presumed renal risk in early diagnosis - is it important?

The panel discusses the importance of early microvascular control. Professor Del Prato emphasises the need for further investigation of renal function in the VERIFY population and the safety and tolerability profile of the treatment.

Key VERIFY takeaways

Should initiation be with a single fixed dose combination?

Professor Del Prato offers his perspective on treatment adherence, and the efficacy and safety profile of combination therapies.

VERIFY: key learnings

Reflections on outcomes from the VERIFY study include benefit for patients, physicians and payers.

VERIFY: baseline characteristics

Find out who was included in the VERIFY study and see how the trial population is truly representative of real-world, newly diagnosed and ethnically diverse T2DM patients.

VERIFY: primary results in young-onset T2DM

In the VERIFY study, sub-group analyses found that patients with young-onset T2DM benefit significantly from vildagliptin and metformin combination treatment compared to metformin treatment alone.

VERIFY: durability

Watch how the VERIFY study provides unique long-term data on the durability of glycaemic control, β-cell function, insulin resistance, early progression of diabetic complications and health status in treatment with a vildagliptin plus metformin treatment combination.

VERIFY: unique design

VERIFY has a unique and pragmatic study design that aimed to confirm whether early usage of vildagliptin plus metformin combination can induce longer glycaemic control compared to metformin alone over a 5-year treatment period during which patients’ treatment is consecutively intensified, if clinically indicated.

VERIFY moving forward

VERIFY: establishing a good diabetic legacy with early combination therapy

In this video Professor Del Prato shares the risks associated with poor glycaemic control and briefly summarises the key VERIFY trial findings that reveal the greater and durable long-term benefits of an early intervention with a vildagliptin and metformin combination, compared to existing standard-of-care.

VERIFY: results in the context of disease pathogenesis

Professor Brath describes the pathogenesis of diabetes with the progressive loss of β-cell function that can contribute to treatment failure and reduced glycaemic control. He highlights the beneficial effect of early intense treatment on β-cell function that leads to improved durability of glycaemic control and time to second failure.

Early combination treatment in practice

Professor Juliana Chan talks about the evidence gap in diabetic patients and the unmet needs that remain. She looks into the key results of the VERIFY study and discusses the need to integrate an early detection strategy to translate the VERIFY study results into practice.

Who benefits most from an early combination treatment?

Engage with key queries from the European Association for the Study of Diabetes (EASD) 2020 symposium as Professor Blüher, Professor Brath, and Professor Chan answer burning questions on the VERIFY study and early combination treatments.

Differentiating VERIFY from CVOTs

Gain a clear introduction to the differences between the VERIFY study and other CVOTs, and how primary and secondary cohort sample sizes differ according to the likelihood of CV events.

Understanding graphical data in VERIFY

Learn why the VERIFY study is different from other CVOTs in an easy to understand graphical representation based on the design of the study.

Reference

Matthews DR, Paldánius PM, Proot P, Chiang YT, Stumvoll M, Del Prato S. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial. Lancet. 2019;394(10208):1519–1529.

Learn how the Societal Impact Model can quantify the societal implications of early combination treatment for patients with type 2 diabetes

To quantify the long-term health and socioeconomic impacts of healthcare interventions in type 2 diabetes mellitus, the Societal Impact Model was developed by experts at the WifOR Institute in collaboration with Novartis. As a case study, this model was used to estimate the societal impacts of early intensified treatment for patients with type 2 diabetes mellitus in Mexico, informed by clinical outcome data from the VERIFY study¹. The results of this Societal Impact Model case study were reported in a peer-reviewed publication by Tsotra and colleagues (2022²).

Listen to Professor Dennis A Ostwald, CEO of the WifOR Institute in Germany, as he explains the relevance of key results from Societal Impact Model case study¹, and how this evidence can be used to estimate the societal impact of treatments for healthcare decision-makers.

Read on below to learn more about the importance of considering the societal impacts of treatment, the factors considered in the Societal Impact Model, and detailed results of the case study of people with type 2 diabetes in Mexico.

Why consider the societal impacts of treatment?

Join Professor Ostwald as he explores the importance of considering societal impact of treatments and how it can influence healthcare decision-making.

Below, Professor Ostwald explains how considering the societal impact of treatments in type 2 diabetes can benefit patients living with the condition, and wider healthcare systems.

The Societal Impact Model

Watch the infographic video overview below to learn about how the Societal Impact Model can estimate the long-term societal impacts of therapeutic approaches in patients with type 2 diabetes.

Using the Societal Impact Model

A case study in a population with type 2 diabetes in Mexico

In this infographic video, learn more about how the Societal Impact Model was used to estimate the long-term societal implications of early intensified treatment in patients with newly diagnosed type 2 diabetes in Mexico, compared with the standard-of-care, late combination strategy. In this case study, hear about how this model was used to estimate the impacts of both treatment strategies on paid and unpaid productivity, using key clinical outcome data from the VERIFY study¹.

Results of the Societal Impact Model

Results of the case study in a population with type 2 diabetes in Mexico

What are the societal impacts of early intensified treatment for people with type 2 diabetes in Mexico? Watch the infographic video below to learn key results from this societal impact modelling study². Learn about how the Societal Impact Model was used to estimate long-term impacts of treatment on productivity, to determine the incremental difference in associated costs between the two treatment groups.

Learn more about societal impact

Listen to the video below to learn more from Professor Ostwald about the value of considering societal impacts of treatments for type 2 diabetes, and how this data can be used to influence healthcare decision-making.

Publication and downloadable resources

Please click on the link here to access the full publication.

You can also download the Diabetes Societal impact tool and the user guide from below - these resources have been developed by WiFOR research institute in collaboration with Novartis.

References

1. Matthews DR, Paldánius PM, Proot P, Chiang YT, Stumvoll M, del Prato S. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial. The Lancet. 2019;394(10208):1519–1529.
2. Tsotra F, Kappel M, Peristeris P, Bader G, Levi E, Lister N, et al. The societal impact of early intensified treatment in patients with type 2 diabetes mellitus. J Comp Eff Res. 2022;11(16):1185–1199.

Women: Considerations and challenges

Key considerations in the management of T2DM in women

Professor Blüher discusses the critical phases through which women with type 2 diabetes mellitus (T2DM) must be guided.

Challenges in treatment of younger women

A case example is presented to illustrate unmet need in treating younger women with T2DM, for which there is underlying evidence.

Why T2DM in women is so important

The striking effects of type 2 diabetes on both cardiovascular and non-cardiovascular events in women are shown.

Challenges of managing T2DM in young women

There is an important under-representation of young women with T2DM in clinical studies.

Contraception, pregnancy challenges, needs and clinical dilemmas

The importance of effective glycaemic control in circumstances specific to women with T2DM is considered, and the care of women with type 1 and type 2 diabetes is contrasted. The risks associated with inadequate metabolic control in pregnancy are highlighted.

Menopause and T2DM

What do we know about the impact of T2DM on women who have reached menopause?

Women: T2DM options and advice

How can we detect T2DM early in young women at risk?

Using standardised risk questionnaires is one component of effective early detection.

If women refuse to start insulin during pregnancy, what are the options to consider?

Diet and exercise are an important component of care for women in the setting of pregnancy and T2DM, discussed here alongside pharmacological interventions.

‘No carb low carb’ diet during pregnancy

The panel discuss the importance of a quality balanced diet in pregnancy, with reference to pre-diabetes as well as T2DM. What changes can be made in a safe and sustained way? Clinician guidance regarding weight and diet is contrasted with other patient populations.

Women with diabetes in low resource areas

What are the issues for women with diabetes in low resource areas, and how can they be supported?

Type 2 diabetes in the elderly

Prevalence of diabetes in older adults and clinical trials: what is the relevance?

Dr David Strain addresses the disparity between the worldwide prevalence of diabetes in the elderly and the relative inclusion of this patient population in clinical trials.

Meet Sylvia: complications in elderly patients

Cognitive complications in frail, elderly patients are an important consideration when offering diabetic treatments.

Relationship between blood sugar and dementia

Hypoglycaemia can have a significant effect; is it well understood and easily identifiable in elderly adults?

Patient case study: individualised treatment for Sylvia

Explore the relative weight of elements to consider when making decisions about glycaemic targets. There are specific considerations for elderly patients when individualising care, focused around ensuring quality of life.

Do young and elder patients respond differently to Sodium-glucose co-transporter-2 (SGLT2) inhibitors?

Side effects in distinct patient populations can determine decisions about which therapeutic agents to use for best effect.

Type 2 diabetes and Ramadan

Ramadan, fasting and T2DM

Effective and safe care of patients who are fasting requires careful understanding on the part of clinicians. Dr Mohamed Hassanein explores key topics focused on fasting in the context of diabetes, with reference to data including from the CREED study.

Blood glucose levels and fasting in patients with T2DM

Fluctuating blood glucose levels during and after fasting in patients with diabetes may add a number of risks for some individuals.

Hypoglycaemia, diabetic ketoacidosis (DKA) and what practical guidelines tell us

The Ramadan prospective study and CREED study provide key information about identifying patients particularly at risk of hypoglycaemia or diabetic ketoacidosis (DKA). Practical guidelines empower clinicians, patients and religious leaders.

Ramadan: how can healthcare professionals (HCPs) assess individuals’ risk

An individualised approach is key to HCP assessment of risk in relation to fasting in people with diabetes.

Pre-Ramadan education: 6 key areas of focus

Dr Hassanein provides detailed information regarding how clinicians can support those fasting. Individualised treatment is central to an approach that requires effective education, communication and treatment decisions.

Type 2 diabetes in different ethnicities

Pooled analysis of different ethnicities: insulin sensitivity and β-cell function

Professor Stefano Del Prato explains the interaction between β-cell function and insulin sensitivity in T2DM patients of different ethnicities. Discover how assessing β-cell function may enable tailored treatment.

Patient unmet needs, type 2 diabetes

Meet Delia Gooding, a 72 year old female diagnosed with diabetes 14 years ago. Delia highlights some of the challenges and unmet needs she encountered during the initial diagnosis period, and how she found it very difficult to process all of the information provided to her, which was sometimes unclear. Delia also highlights the importance of individualised patient care, with clear and concise information on how diabetes will impact the patient’s life.

Patient perspective, type 2 diabetes

Delia Gooding, a 72 year old living with diabetes for 14 years offers advice on how patients can deal with their initial diagnosis of diabetes and how physicians can support their patients who have recently been diagnosed.

Perspective: Patient self-management of chronic diseases such as type 2 diabetes

Delia looks back on how her life has changes since her initial diagnosis, and methods which she used to overcome hurdles associated with having type 2 diabetes. This includes the importance of maintaining a healthy diet and weight management, along with control of insulin consumption.

Hear Professor Blüher’s thoughts on EASD 2021

In this quick one-minute vLog, Matthias Blüher answers the question, ‘how fast is β-cell function lost over the disease course?’ You can watch his longer congress presentation from the 57^th European Association for the Study of Diabetes (EASD) below.

β-cell loss in treatment-naïve T2DM patients – results from 15 clinical trials

Join Professor Matthias Blüher as he discusses findings from 15 recent clinical trials on the rate of β-cell loss in the early stages of T2DM. Explore the impact of metabolic control and better understand the importance of early diagnosis.

β-cell function and insulin resistance early in the disease

Join Professor Stefano Del Prato in this short vLog as he reviews findings from 17 clinical trials measuring beta cell function in IGT and T2DM. Gain insight into how assessing insulin sensitivity offers potential for individualising treatment.

Clinical inertia and treatment intensification

We explore the challenge of clinical inertia and the benefit of treatment intensification.

In practice is it the patient that is ‘failing’, or is strategy failing the patient?

DPP-4 inhibitor use and COVID-19

Gain insight into the implications of COVID-19 in T2DM patients and explore findings including recent evidence supporting DPP-4 inhibitor use for improving outcomes in COVID-19 patients with T2DM.

In practice is it the patient that is ‘failing’, or is strategy failing the patient?

How appropriate is it to refer to the patient as ‘failing’? Professor Del Prato considers a more positive, proactive approach to achieving and maintaining glycaemic control.

Should drug holidays be considered?

Challenging the treatment paradigm includes consideration of what might or should be done where glycaemic control is achieved. Watch the panel’s impassioned responses to the question of drug holidays.

Clinically relevant gender differences and impact on risk

Professor Blüher highlights the impact of gender on both the development of type 2 diabetes mellitus (T2DM) and clinical outcomes. Can risk be identified and diminished?

Are there gender specific risk factors for T2DM?

Body Mass Index has a central role to play in relation to risk of developing T2DM.

Gender difference and challenges in management of T2DM

There are a large number of gender differences and associated challenges in the context of managing T2DM. These are explored here, particularly in relation to response to treatment and clinical outcomes.

Why do IFG and IGT occur differently in different sexes?

Impaired fasting glucose (IFG) may be more frequently diagnosed in men. Impaired glucose tolerance (IGT) may be difficult to diagnose, especially in women.

What is the impact of ethnicity on this difference between IFG and IGT?

The effect of incretin hormones is considered in relation to ethnicity. Dr Strain considers microcirculation differences in relation to gender and the impact these may have on delivery of key substances to tissues.

Are gender-related factors responsible for why men and women respond differently to different treatments?

Professor Chantal Mathieu considers whether clinical differences seen in men and women are driven by physiological factors related to gender. She addresses the topic of regimen acceptance, which may differ between sexes, but for distinct reasons.

Insulin initiation – how to treat men and women

Are there differences in the way clinicians treat men and women? Dr Strain and Professor Blüher consider the ways they behave in their practice.