Xultophy DUAL V Quiz

DUAL V was published in

• BMJ 2016

• Diabetes Care 2015

• NEJM 2016

• JAMA 2016

Main authors of DUAL V are

• Ildiko Lingvay

• Liana K. Billings

• Federico Pérez Manghi

• None of above

Objective of the study was to assess whether a fixed ratio of insulin degludec/liraglutide was ____ to continued titration of insulin glargine in patients with uncontrolled type 2 diabetes treated with insulin glargine and ____

• Superior / OADs

• Noninferior / Metformin

• Equivalent / SU's

• Noninferior / OADs

Secondary objectives of the trial include

• change from baseline of HbA1c level

• Body weight change

• Rate of confirmed hypoglycemia

• All of above

Confirmed hypoglycemic episodes were defined as episodes in which plasma glucose was biochemically confirmed as less than ____, with or without symptoms or in which the patient required assistance.

• 53mg/dL

• 56mg/dL

• 70mg/dL

• None of above

DUAL V was a [A]____, multinational, multicenter, [B] ____, randomized, open-label, 2-group, treat-to-target trial conducted at [C] ___________ from September 2013 to November 2014

• [A] Phase 2

  [B] 26 weeks

  [C] 75 centers in 10 countries

• [A] Phase 3

  [B] 26 weeks

  [C] 75 centers in 10 countries

• [A] Phase 4

  [B] 52 weeks

  [C] 50 centers in 10 countries

• [A] Phase 3

  [B] 52 weeks

  [C] 50 centers in 10 countries

The inclusion criteria included:

• T2DM

• HbA1c 7-10%

• Age ≥ 12 Years

• BMI ≤ 40kg/m²

• All of above

Pre trial dose of insulin glargine:

• >10 Units

• 10-50 Units

• 20-50 Units

• >50 units

Titration was performed [A] ___ weekly based on the mean of three previous daily pre-breakfast SMBG measurements, using an FPG target of [B] ___

• [A] Once weekly

  [B] 4.0-5.0mmol/L

• [A] Twice weekly

  [B] 4.0-5.0mmol/L

• [A] Both once/twice weekly

  [B] 90-110 mg/dl

• [A] Twice weekly

  [B] 72–90 mg/dL

At the end of trial, HbA1c level reduction was [A] ___ with IDegLira vs IGlar; estimated treatment difference [ETD], [B] ___, meeting criteria for [C] ___.

• [A] greater

  [B] -0.59%

  [C] non inferiority

• [A] lesser

  [B] -0.59

  [C] superiority

• [A] higher

  [B] -0.69

  [C] non inferiority

• [A] equal to

  [B] -0.69

  [C] statistical superiority