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 |
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Written consent of the subject to participate; the subject understands the requirements of the clinical investigation and is willing to comply | X |
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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 |
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Confirmation that all inclusion criteria are met and that there are no violations of any exclusion criteria | X |
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Assessment of body weight & height, BMI | X |
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Blood sampling for screening laboratory parameters (including HbA1c, fasting blood glucose and thyroid-stimulating hormone) | X |
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Dipstick urinalysis for the assessment of glucose and proteins | X |
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Pregnancy test in urine (women with childbearing potential) | X |
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Measurement of blood pressure and pulse rate | X | X | X | X |
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Documentation of possible occurrence of adverse events (AEs) | X | X | X | X | X |
Questioning on menstrual cycle | X | X | X | X |
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Issue of information on restrictions prior to test days | X |
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Handing out standardized meal for the dinner on the day before next visit | X | X | X |
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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 |
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Questioning with respect to any changes in dietary/sleep habits and level of physical activity |
| X | X | X |
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Randomization and use of 1st IP |
| X |
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Assessment of body weight |
| X | X | X |
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Standardized breakfast |
| X | X | X |
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Blood sampling for glucose and insulin −15 to 180 min |
| X | X | X |
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Gastrointestinal tolerability assessment by subject 0 to 240 min |
| X | X | X |
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Handing out subject diary and instructions for use |
| X | X | X |
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Global evaluation of benefit and tolerability of the treatment type by the subjects and by the investigators |
| X | X | X |
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First cross-over and use of 2nd IP |
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| X |
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Collection and control of subject diary |
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| X | X | X |
Second cross-over and use of 3rd IP |
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| X |
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