EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES OFFICIAL HIGHLIGHTS

EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES

Conference summaries


T2D & INSULIN

CONCLUDE: a trial COmparing the efficacy aNd safety of insulin degLUDEc and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin and oral antidiabetic drugs

Presented by: Thomas Pieber, MD
Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria
Athena Philis-Tsimikas, MD
Scripps Whittier Diabetes Institute, La Jolla, CA, USA
  • In the CONCLUDE trial comparing degludec U200 to glargine U300, some differences were seen in selected endpoints such as hypoglycaemia and weight gain during the maintenance period.
  • It is unclear if the differences observed can be generalised to apply in clinical practice.

New longer-acting basal insulin analogues such as insulin degludec (degludec) and insulin glargine 300 units/mL (glargine U300) are recognised for their peakless pharmacodynamic profiles, contributing to low variability in glucose-lowering effect, compared to insulin glargine 100 units/mL (glargine U100). Contrasting results were observed in two studies comparing degludec and glargine U300 for within-day glucose variability. It can, however, be expected that the distinct pharmacodynamic profiles of these insulins differentially influence their clinical profiles and the risk of hypoglycaemia.

  • The head-to-head CONCLUDE study compared degludec U200 and glargine U300 with the primary objective of examining the risk of hypoglycaemia.

Type of study, patients, and inclusion criteria

  • Randomised, open-label, treat-to-target, multinational trial.
  • Participants were randomised 1:1 to degludec U200 or glargine U300.
  • Key inclusion criteria included ≥18 years old with type 2 diabetes, HbA1c ≤9.5%, BMI ≤45 kg/m2 and treatment with basal insulin with or without any combination of metformin, DPP-4 inhibitors, α-glucosidase inhibitors, thiazolidinediones and SGLT-2 inhibitors at stable doses ≥90 days prior to screening.
  • A 16-week titration period was followed by a 36-week maintenance period.

Patient population

  • Total patients randomised: 1609.
  • Degludec U200 (n = 805).
  • Glargine U300 (n = 804).

Primary outcome measure

  • The primary endpoint was the number of severe or blood glucose-confirmed symptomatic hypoglycaemic episodes during the maintenance period.
  • During the maintenance period, there was no significant difference in overall hypoglycemic events, which were 40.6% with degludec versus 46.3% with glargine U300 (rate ratio, 0.88; P = 0.17)
  • Glargine U300 was associated with significantly more severe hypoglycaemic events than degludec U200 (RR 0.20; 95% CI 0.07-0.57; P = 0.0027), but not the number of overall symptomatic episodes (RR 0.88; 95% CI 0.73-1.06; P = 0.17).
  • Post-hoc analyses showed lower HbA1c and fasting plasma glucose levels at the end of treatment for degludec U200 and less weight gain for glargine U300.
  • Lower doses were used for degludec U200 compared to glargine U300.
  • There were no differences in hypoglycaemia during the titration period, and no differences in the overall safety profiles.
  • While differences were seen in some endpoints, it is unclear if the results can be generalised to apply in clinical practice.
  • Interpretation of the results should be seen within the broader context of the totality of the trial results.

Key Messages/Clinical Perspectives

  • It is unclear if the differences observed in some endpoints in the CONCLUDE trial can be generalised to apply in clinical practice.

 

Trial: NCT03078478




Presenter disclosure: The presenters have reported that no relationships exist relevant to the contents of this presentation.

Medical writer: Patrick Moore, PhD

Reviewer: Marco Gallo, MD

Local reviewers: Marco Gallo, MD (Italia); Anna Novials Sardá, MD, PhD (España); Eric Renard, MD, PhD (France); Peter Schwarz, MD, PhD (Deutschland) 

Scientific Editor: Florian Toti, MD


CLINICAL TRIALS

T2D & NEPHROPATY

CREDENCE – Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy

Presented by: Carol Pollock, MBBS, PhD, FRACP, AAHMS; Hiddo Lambers Heerspink, PharmD, PhD; Kenneth W. Mahaffey, MD

PREVENTION

Results from the Anti-CD3 mAb (teplizumab) prevention trial

Presented by: Kevan Herold, MD; Peter S. Linsley, PhD

DIABETES & CVD

DECLARE study: call for action

Presented by: Itamar Raz, MD; Ofri Mosenzon, MD, MSc; Avivit Cahn, MD

T2D TREATMENT

VERIFY – Vildagliptin Efficacy in combination with metfoRmIn For earlY treatment of type 2 diabetes

Presented by: Chantal Mathieu, MD; Michael Stumvoli, MD; David R. Matthews, MD; Stefano del Prato, MD

DIABETES & HF

DAPA-HF: dapagliflozin and prevention of adverse-outcomes in heart failure

Presented by: Mikhail Kosiborod, MD; Silvio Inzucchi, MD

CV SAFETY

Results and implications of CAROLINA (CARdiOvascular Safety of LINAgliptin) comparing linagliptin vs glimepiride

Presented by: Julio Rosenstock, MD; Mark A. Espeland, MD; Steven E. Kahn, MD; Nikolaus Marx, MD; Bernard Zinman, MD; Darren McGuire, MD

T2D & CV PREVENTION

T1D DETERMINANTS

The Environmental Determinants of Diabetes in the Young (TEDDY) study

Presented by: Anette-Gabriele Ziegler, MD; Heikki Hyöty, MD, PhD
 

SYMPOSIA

NAFLD & DIABETES

EASD/EASL Symposium: is NAFLD a risk for health in the context of diabetes?

Presented by: Michael Roden, MD; Stefano Romeo, MD; Elisabetta Bugianesi, MD, PhD

HF & T2D

EASD/ESC Symposium: heart failure in type 2 diabetes

Presented by: M. Louis Handoko, MD; Javed Butler, MD, MPH, MBA

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