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. 2017 May 10;2017(5):CD012204. doi: 10.1002/14651858.CD012204.pub2
Trial All‐cause mortality Incidence of T2DM Serious adverse events Cardiovascular mortality Non‐fatal myocardial infarction Non‐fatal stroke Congestive heart failure Amputation of lower extremity
Ariel 2014 N/I N/I N/I N/I N/I N/I N/I N/I
Kelly 2012 N/I N/I SAE N/I N/I N/I N/I N/I
Martinez‐Abundis 2015 N/I N/I N/I N/I N/I N/I N/I N/I
McLaughlin 2011 N/I N/I N/I N/I N/I N/I N/I N/I
Rosenstock 2008 Deaths
(IO)
Reported as adverse events. Assume definition was identical with the definition of T2DM in the exclusion criteria: FPG ≥ 126 mg/dL (7.0 mmol/L) at visit 1 (week ‐4); 2‐hour post‐challenge plasma glucose (after OGTT 75‐g glucose) ≥ 200 mg/dL (11.1 mmol/L) (IO) "All adverse events were recorded and assessed as to their severity and possible relationship to the study medication as judged by the investigator" (IO) N/I N/I N/I Heart failure (IO) N/I
Rosenstock 2010 Deaths (IO) T2DM (IO) SAE (IO) N/I N/I N/I N/I N/I
SCALE Deaths (IO/AO) Quote: "Furthermore, patients were diagnosed with type 2 diabetes based on the following criteria:
  • HbA1c measurement of ≥6.5%, or

  • fasting plasma glucose measurement ≥126 mg/dl (7.0 mmol/liter), or

  • 2‐hour plasma glucose measurement post‐challenge (oral glucose tolerance test) ≥200 mg/dl (11.1 mmol/liter)."


Measurements of FPG and 2‐hour glucose values after an OGTT had to be confirmed in repeated assessments (IO)
Quote: "A SAE is an experience that at any dose results in any of the following:
  • Death

  • A life‐threatening* experience

  • In‐patient hospitalisation** or prolongation of existing hospitalisation

  • A persistent or significant disability/incapacity***

  • A congenital anomaly/birth defect

  • Important medical events**** that may not result in death, be life‐threatening*, or require hospitalisation may be considered a SAE when, based upon appropriate medical judgement, they may jeopardise the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition."


* "life‐threatening" in the definition of SAE refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe.
 ** "hospitalisation" is the definition of a participant admitted to a hospital/inpatient (irrespective of the duration of physical stay), or not admitted to a hospital/not inpatient, but stays at the hospital for treatment or observation for > 24 hours. Medical judgement must always be exercised, and when in doubt, the hospital contact should be regarded as a hospitalisation. Hospitalisations for administrative, trial related and social purposes do not constitute AEs and should therefore neither be reported as AEs or SAEs. Likewise, hospital admissions for surgical procedures planned prior to trial inclusion are not considered AEs or SAEs.
 *** "disability/incapacity" means that following the event the participant or clinical investigation participant has significant, persistent or permanent change, impairment, damage or disruption in his body function or structure, physical activity or quality of life (or both).
 ****"important medical events" means events which may jeopardise the participant or require intervention to prevent a seriousness criterion. It can be adverse events which suggest a significant hazard or puts the participants or clinical investigation participants at risk, such as drug interaction, contraindications or precautions, occurrence of malignancies or development of drug dependency or drug abuse (IO/AO)
"Cardiovascular death, includes
  • Sudden cardiac death

  • Death due to acute myocardial infarction

  • Death due to heart failure or cardiogenic shock

  • Death due to stroke

  • Death due to other cardiovascular causes."


1 participant died from cardiac arrest (IO/AO)
Acute coronary syndrome (myocardial infarction or hospitalisation for unstable angina) (IO/AO) Cerebrovascular event (stroke or transient ischaemic attack) (IO/AO) Heart failure requiring hospitalisation
(IO/AO)
N/I
aIn addition to definition of endpoint measurement, description who measured the outcome (AO: adjudicated outcome measurement; IO: investigator‐assessed outcome measurement; SO: self‐reported outcome measurement).
AE: adverse event; AO: adjudicated outcome measurement; FPG: fasting plasma glucose; HbA1c: glycosylated haemoglobin A1c; IO: investigator‐assessed outcome measurement; N/I: not investigated; OGTT: oral glucose tolerance test; SAE: serious adverse event; SCALE: Satiety and Clinical Adiposity ‐ Liraglutide Evidence in Nondiabetic and Diabetic Individuals; T2DM: type 2 diabetes mellitus.