Table 2

Assessments and procedures during screening and study visits (D, day; W, week)* Not including administration of weekly exenatide QW/sham injection

ProcedureD
−42–2
(including washout if necessary)
D
−14–0
D
0
W
2
W
4
W
8
W
12
W
16
W
20
W
24
W
28
W
30–32
Visit (fasting)01 and 234567891011 and 12
Informed consentX
Medical history/demographicsX
Physical examination and ECGX
Pregnancy testXX
Glucometer dispensing and trainingX
UrinalysisX
HeightX
WeightXXXXXXXXXXX
Waist and hip measurementsXXXXXXXXXX
Bioelectrical impedance analysis (BIA)XXXXXXXXXX
BP, pulseXXXXXXXXXXX
Blood testsXXXXXXXXXXX
Dapaglifozin/placebo dispensingXXXXXXXXX
Concomitant medication checkXXXXXXXXXXX
Compliance checkXXXXXXXXX
AE reportingXXXXXXXXXX
24-hour urineXXXX
4-day food diaryXXXX
4-day activity monitoringXXXX
Test mealXXXX
Indirect calorimetryXXXX
Psychological questionnaires and VASXXXX
DEXAXX
MRI (full body, liver fat, pancreatic fat)XX
MRI cardiacXX
fMRI and eye-trackingXX
FMDXX
Cardiac ECHOXX
DLW and additional DEXAXXXXX
Euglycaemic clampsXX
  • *Not including administration of weekly exenatide QW/sham injection.

  • AE, adverse event; BIA, bioelectrical impedance analysis; BP, blood pressure; DEXA, dual-energy X-ray absorptiometry; DLW, doubly labelled water; ECG, electrocardiogram; FMD, flow-mediated dilatation; fMRI, functional MRI; VAS, Visual Analogue Scale.