Procedure

Visit 1

Screening

Visit 2

Randomization

Visit 3

1st cross-over

Visit 4

2nd cross-over

Visit 5

End of study

Oral and written information about the nature, purpose, possible risks and benefits of the study provided to the subjects by the investigator

X

Written consent of the subject to participate; the subject understands the requirements of the clinical investigation and is willing to comply

X

Questioning and documentation of the anamnestic data (including medical history, concurrent diseases), concurrent treatment and supplementation, demographic and anthropometric data, and physical examination by the investigator

X

Confirmation that all inclusion criteria are met and that there are no violations of any exclusion criteria

X

Assessment of body weight & height, BMI

X

Blood sampling for screening laboratory parameters (including HbA1c, fasting blood glucose and thyroid-stimulating hormone)

X

Dipstick urinalysis for the assessment of glucose and proteins

X

Pregnancy test in urine (women with childbearing potential)

X

Measurement of blood pressure and pulse rate

X

X

X

X

Documentation of possible occurrence of adverse events (AEs)

X

X

X

X

X

Questioning on menstrual cycle

X

X

X

X

Issue of information on restrictions prior to test days

X

Handing out standardized meal for the dinner on the day before next visit

X

X

X

Questioning and documentation of new or changed concurrent treatment and supplementation/possible occurrence of AEs

X

X

X

X

Questioning on adherence to restrictions prior to test days

X

X

X

Questioning with respect to any changes in dietary/sleep habits and level of physical activity

X

X

X

Randomization and use of 1st IP

X

Assessment of body weight

X

X

X

Standardized breakfast

X

X

X

Blood sampling for glucose and insulin −15 to 180 min

X

X

X

Gastrointestinal tolerability assessment by subject 0 to 240 min

X

X

X

Handing out subject diary and instructions for use

X

X

X

Global evaluation of benefit and tolerability of the treatment type by the subjects and by the investigators

X

X

X

First cross-over and use of 2nd IP

X

Collection and control of subject diary

X

X

X

Second cross-over and use of 3rd IP

X