Table 1

Schematic overview of study visits

VisitV0V1V2V3V4
Time, days from intervention start−90*−64291182
Participant-related information
 Informed consentX
 HistoryX
 Inclusion/Exclusion criteriaX
 Clinical examinationXXXX
Efficacy and safety outcomes
 HbA1C XXXXX
 Body weightXXXXX
 HeightX
 Waist circumferenceXXXX
 Blood pressureXXXX
 Pregnancy testX(X)(X)(X)(X)
 Fasting blood samplesXXXX
 Urine samplesXXXX
 Indirect calorimetryXXX
 Oral glucose tolerance testXXX
 Body fat distribution (DEXA)XXX
 Fitness testXXX
 Free-living physical activity measurementXXXX
 Continuous glucose monitoringXXXX
 Adverse eventsXXX
Questionnaires
 Health and well-beingXXXX
 Physical activityXXXX
 Sleep patternsXXXX
 Food diaryXXXX
 Treatment satisfactionXX
Study medication, drug accountability X
X
  • *The maximum allowed time from the screening (V0) to the baseline examination (V1) is 12 weeks (=84 days). If this is not possible, a new screening will be performed before including the participant in the study.

  • HbA1c, haemoglobin A1c; DEXA, dual-energy X-ray absorptiometry.