Congress Program

* Preliminary Program subject to change

Tuesday, 26 November 2019

08:00-17:00

Registration 

08:50-09:00

Welcome and Opening of The Congress
Philip Home,
Newcastle University, UK

09:00-10:30

Session 1: Ultra-Rapid-Acting Insulins

Chairperson: Philip Home, Newcastle University, UK

09:00-09:30


Marketed Insulins: What Can Be Achieved?

Hans DeVries, University of Amsterdam, the Netherlands and Profil, Germany

  • Pharmacokinetics and pharmacodynamics of ultra-rapid-acting insulins
  • Advantages of ultra-rapid-acting insulins, looking at postprandial glucose and HbA1c
  • Use of ultra-rapid-acting insulins in insulin pumps and the artificial pancreas

09:30-10:00


Prospects for Further Advances

Greg Meiffren, Adocia, Lyon, France

  • Mechanism of action of various Ultra-Rapid Insulins
  • Post-prandial blood glucose control with Ultra-Rapid Insulins
  • Amylin analog / insulin & GLP-1 analog / insulin combinations for post prandial control

10:00-10:30

Discussion: Hans DeVries, Greg Meiffren, Baruch Itzhak

10:30-11:00

Coffee Break, Networking and visit the Exhibition 

11:00-12:30

Session 2: Data Analysis and Interpretation
Chairperson: Eberhard Standl, Munich Helmholtz Center, Germany

11:00-11:30

Bayesian Analysis of Clinical Trials

Nick Freemantle, UCL, UK

11:30-12:00


Assessing CV Safety in T2DM Clinical Trials
Fred Yang, KBP Biosciences, USA

  • CV safety outcome study design
  • Statistical testing controlling Type I error
  • ITT principle for safety analysis

12:00-12:30

Discussion: Nick Freemantle, Fred Yang, Nikolaus Marx

12:30-13:30

Lunch Break, Networking and visit the Exhibition 

13:30-15:00

Session 3: Outcomes and Adjudication
Chairperson: Fred Yang, KBP Biosciences, USA

13:30-14:00


Obesity and Weight Loss in T2DM: What Is the Target?

John Wilding, University of Liverpool, UK

  • Weight loss should be an essential part of treatment for type 2 diabetes
  • Effective weight loss interventions (meal replacements, drugs, surgery) should be considered alongside glucose-lowering therapy for appropriate patients with T2DM
  • Drugs with established CV or renal benefits that help with weight loss should be considered to all who may benefit based on current evidence

14:00-14:30

Diabetes and ageing; what is the relationship?

Philip Home, Newcastle University, UK

14:30-15:00

Discussion: John Wilding, Philip Home, Eberhard Standl

15:00-15:30

Coffee Break, Networking and visit the Exhibition 

15:30-17:00

Session 4: This Year's Clinical Trials: Issues Arising

Chairperson: Marianne Bach Treppedahl, Novo Nordisk, Denmark

15:30-16:00


CAROLINA: Where Now For DPP-4i's and Sulfonylureas
Nikolaus Marx, University Hospital Aachen, Germany

  • Cardiovascular safety of sulfonylureas
  • Cardiovascular safety of DPP-4 inhibitors
  • Cardiovascular outcome data from the CAROLINA trial, comparing the DPP-4 inhibitor Linagliptin vs. the sulfonylurea Glimepiride

16:00-16:30

Primary Prevention: What Does the Evidence Show?

Eberhard Standl, Munich Helmholtz Center, Germany

16:30-17:00

Discussion: Nikolaus Marx, Eberhard Standl, Nick Freemantle


Wednesday, 27 November 2019

08:30-17:00

Registration 

09:00-10:30

Session 5: Clinical Trials Issues

Chairperson: Baruch Itzhak, Clalit Health Services, Haifa, Israel

09:00-09:30


How Should Development Clinical Trials Evolve?

Marianne Bach Treppedahl, Novo Nordisk, Denmark

  • Pragmatic clinical trial may provide opportunities to gain additional scientific insights without the resource-intensive RCTs
  • New trial methodologies and operational concepts may be needed and should be developed in a collaboration among industry, academia and regulators
  • Clinically important results should be translated into product labels for the benefit of patients based on scientific rigorous trial design and robust conduct

09:30-10:00


Prerequisites for Clinical Research in Paediatrics
Bärbel Aschemeier, HKA, Germany

  • Challenges for clinical research in the pediatric age group
  • Regulatory pathway for pediatric studies
  • Developing a clinical trial network for children

10:00-10:30

Discussion: Marianne Bach Treppedahl, Bärbel Aschemeier, Ulrik Pedersen-Bjergaard

10:30-11:00

Coffee Break, Networking and visit the Exhibition 

11:00-12:30

Session 6: Clinical Trials of Insulin Therapy
Chairperson: Ulrik Pedersen-Bjergaard, University of Copenhagen, Denmark

11:00-11:30

Is Insulin Still in The Frame? CV Safety Issues and New Horizons

Baruch Itzhak, Clalit Health Services, Haifa, Israel

11:30-12:00


Closed Loop Insulin Delivery: What Do We Need to Show?

Roman Hovorka, University of Cambridge, UK

  • Closed loop technologies are entering standard clinical practice
  • Gluco-centric benefits include increased time in range and reduced time in hypoglycaemia
  • Psychosocial assessments are important to understand full benefits and drawbacks of closed loop technologies

12:00-12:30

Discussion: Baruch Itzhak, Roman Hovorka, Stephanie Amiel

12:30-13:30

Lunch Break, Networking and visit the Exhibition 

13:30-15:00

Session 7: Hypoglycaemia

Chairperson: Philip Home, Newcastle University, UK

13:30-14:00


Validity of the New Definitions of Hypoglycaemia

Stephanie Amiel, Kings College London, UK

  • Hypoglycaemia is a feared complication of glucose lowering therapies a
  • Miminising hypoglycaemia risk while delivering near-normoglycaemia is a key indicator of safety in diabetes therapies
  • Definitions of hypoglycaemia need to be standardised and clinically meaningful

14:00-14:30


How to Study Hypoglycaemia-Prone People

Ulrik Pedersen-Bjergaard, University of Copenhagen, Denmark

  • There is a need for trials specifically targeting glycaemic intervention in people prone to hypoglycaemia
  • The design of trials should allow for comparison of rates of hypoglycaemia at comparable glycaemic control and seek to reduce the risk of major random effects from individuals with very high hypoglycaemic rates
  • CGM is useful for assessment of asymptomatic hypoglycaemia, which may be very common

14:30-15:00

Discussion: Stephanie Amiel, Ulrik Pedersen-Bjergaard, Ramon Hovorka

15:00-15:15

Congress closing

Philip Home, Newcastle University, UK

15:15-15:30

Coffee Break, Networking and visit the Exhibition