9.2.1. Lead-In and Insulin Transition .............................................................................37

                  9.2.2. Dose-Finding Assessment ....................................................................................38

                  9.2.3. Study Period CRU Visits......................................................................................39

                   9.2.3.1. Run-In ............................................................................................................39

                   9.2.3.2. Study MMTT .................................................................................................39

                9.3. Adverse Events ............................................................................................................39

                  9.3.1. Serious Adverse Events........................................................................................40

                   9.3.1.1. Suspected Unexpected Serious Adverse Reactions..........................................41

                  9.3.2. Complaint Handling .............................................................................................41

                9.4. Treatment of Overdose.................................................................................................41

                9.5. Safety...........................................................................................................................42

                  9.5.1. Physical Examination...........................................................................................42

                  9.5.2. Laboratory Tests ..................................................................................................42

                  9.5.3. Vital Signs ...........................................................................................................42

                  9.5.4. Electrocardiograms ..............................................................................................42

                  9.5.5. Other Tests...........................................................................................................43

                   9.5.5.1. Hip and Waist Circumference .........................................................................43

                   9.5.5.2. Body Weight and Height ................................................................................43

                  9.5.6. Safety Monitoring ................................................................................................43

                   9.5.6.1. Hepatic Safety ................................................................................................43

                   9.5.6.2. Glucose Monitoring........................................................................................44

                   9.5.6.3. Severe Hypoglycemia.....................................................................................45

                   9.5.6.4. Injection Site Assessments (Local Tolerability) ..............................................45

                  9.5.7. Self-Monitored Plasma Glucose during Outpatient Period ....................................45

                  9.5.8. Treatment of Hyperglycemia and Hypoglycemia..................................................46

                9.6. Pharmacokinetics Samples ...........................................................................................46

                  9.6.1. Bioanalysis...........................................................................................................46

                9.7. Pharmacodynamics ......................................................................................................46

                  9.7.1. Glucodynamics Samples ......................................................................................47

                   9.7.1.1. Glucose Samples (Run-In Period) ...................................................................47

                   9.7.1.2. Glucose Samples (MMTT) .............................................................................47

                  9.7.2. Samples for Immunogenicity Assessments ...........................................................47

                9.8. Genetics .......................................................................................................................47

                9.9. Biomarkers...................................................................................................................48

                9.10. Health Economics ........................................................................................................48

Section label: Study Protocols