NCT03421379 — consolidated Schedule of Activities

usdm_data · 1 tables · 36 activities (0% compression) · 8 columns · study-schedule-consolidated v1.0 · Layer 3
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▼ Main Schedule (8 columns)
ActivityInTable 1
Study Period
[epoch] L1		ScreeningPeriod 1Period 1Wash outPeriod 2Period 2Follow-up/EDAdditional Follow-up for TE ADA1
Study Day
[study_day] L2		Days -28 to -2Day -1Day 13 to 14 daysDay -1Day 1Within 28±2 days after last study treatment
Clinical AssessmentsT1
Informed ConsentT1X
RandomizationT1X
Admission to CRU2T1XX
Discharge from CRU3T1XX
Medical HistoryT1X
Collect Pre-existing Conditions and Adverse EventsT1XXXXXXX
Physical Exam4T1X240 min240 minX
Height and Weight5T1XPre-hypoglycemia inductionPre-hypoglycemia inductionX
Collect Hypoglycemic Events6T1XX
Collect Concomitant Medications7T1XXXXXXX
Meal8T1XX
Insulin infusion to Induce Hypoglycemia9T1XX
Bedside PG Monitoring for Safety10T1XX
Study Treatment Administration11T1XX
Injection-Site Assessment12T1Pre-hypoglycemia induction, 90 minPre-hypoglycemia induction, 90 min
Nasal Inspection13T1Pre-hypoglycemia induction, 90 minPre-hypoglycemia induction, 90 min
Vital Signs (Supine Blood Pressure, Pulse Rate, and Body Temperature)14T1XPre-hypoglycemia induction, Predose, 15, 30, 60, 120, 240 minPre-hypoglycemia induction, Predose, 15, 30, 60, 120, 240 minX
Single 12-lead ECG (Local)T1XX
Triplicate 12-lead ECG (Central)15T1Pre-hypoglycemia induction (30 and 15 min prior to insulin infusion), Predose, 15, 30, 60, 120, 240 minPre-hypoglycemia induction (30 and 15 min prior to insulin infusion), Predose, 15, 30, 60, 120, 240 min
Laboratory TestsT1
Clinical Serology Tests16T1X
Clinical Lab Tests (Hematology, Clinical Chemistry, and Urinalysis)17T1XPre-hypoglycemia inductionPre-hypoglycemia inductionX
HbA1c16T1XPre-hypoglycemia induction
Pregnancy Test (Female patients of childbearing potential only)18T1XXXX
FSH (Female patients only)19T1X
Ethanol Testing20T1X
Urine Drug Screen20T1X
PK (Glucagon)21T1Pre-hypoglycemia induction, Predose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minPre-hypoglycemia induction, Predose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minXX
Plasma Glucose for PD22T1Pre-hypoglycemia induction, -5, Predose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minPre-hypoglycemia induction, -5, Predose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 min
Genetic Sample (Stored)23T1X
Anti-glucagon Antibodies24T1Pre-hypoglycemia inductionXX
Health Outcome InstrumentsT1
Clarke Hypoglycemia Awareness SurveyT1X
Nasal and Non-nasal Score Questionnaire25T1Pre-hypoglycemia induction, 15, 30, 60, 120 minPre-hypoglycemia induction, 15, 30, 60, 120 min
Edinburgh Hypoglycemia Scale: Experimental Hypoglycemia26T1Pre-hypoglycemia induction, During hypoglycemia induction, Predose, 15, 30, 60, 120 minPre-hypoglycemia induction, During hypoglycemia induction, Predose, 15, 30, 60, 120 min
▼ Matches across tables no matches to review
Rows that consolidation merged on name similarity, or kept separate from a near match. Whether two rows are the same activity is the reviewer's call: choosing drafts an entry for NCT03421379_consolidation_corrections.json below; nothing is saved from here. Rows merged on an identical name are not listed. Words that only one of the two names prints are marked; the score ignores case, hyphens, slashes, text in parentheses and plural endings.
Draft — new file consolidated/NCT03421379_consolidation_corrections.json; replace each <why>, then re-run consolidation.
▼ Consolidation Metadata Process information
consolidated_at2026-10-03T19:23:30.191535+00:00
source_activity_count36
unified_activity_count36
compression_percent0
match_statsnew: 36
▼ Source Tables 1 tables
tabletypetracktitle / purposeactscolsprops
T1 main_soa Study Schedule Protocol I8R-JE-IGBJ
Main study schedule: screening, two crossover dosing periods with washout, follow-up/ED and additional TE ADA follow-up		 36 8 2
▼ Unified Activities 36 activities
xact_idactivity_name (variations)parentmatch#tablesrow kind
xact-001 Clinical Assessments one table 1 T1 section
xact-002 Informed Consent Clinical Assessments one table 1 T1
xact-003 Randomization Clinical Assessments one table 1 T1
xact-004 Admission to CRU Clinical Assessments one table 1 T1
xact-005 Discharge from CRU Clinical Assessments one table 1 T1
xact-006 Medical History Clinical Assessments one table 1 T1
xact-007 Collect Pre-existing Conditions and Adverse Events Clinical Assessments one table 1 T1
xact-008 Physical Exam Clinical Assessments one table 1 T1
xact-009 Height and Weight Clinical Assessments one table 1 T1
xact-010 Collect Hypoglycemic Events Clinical Assessments one table 1 T1
xact-011 Collect Concomitant Medications Clinical Assessments one table 1 T1
xact-012 Meal Clinical Assessments one table 1 T1
xact-013 Insulin infusion to Induce Hypoglycemia Clinical Assessments one table 1 T1
xact-014 Bedside PG Monitoring for Safety Clinical Assessments one table 1 T1
xact-015 Study Treatment Administration Clinical Assessments one table 1 T1
xact-016 Injection-Site Assessment Clinical Assessments one table 1 T1
xact-017 Nasal Inspection Clinical Assessments one table 1 T1
xact-018 Vital Signs (Supine Blood Pressure, Pulse Rate, and Body Temperature) Clinical Assessments one table 1 T1
xact-019 Single 12-lead ECG (Local) Clinical Assessments one table 1 T1
xact-020 Triplicate 12-lead ECG (Central) Clinical Assessments one table 1 T1
xact-021 Laboratory Tests one table 1 T1 section
xact-022 Clinical Serology Tests Laboratory Tests one table 1 T1
xact-023 Clinical Lab Tests (Hematology, Clinical Chemistry, and Urinalysis) Laboratory Tests one table 1 T1
xact-024 HbA1c Laboratory Tests one table 1 T1
xact-025 Pregnancy Test (Female patients of childbearing potential only) Laboratory Tests one table 1 T1
xact-026 FSH (Female patients only) Laboratory Tests one table 1 T1
xact-027 Ethanol Testing Laboratory Tests one table 1 T1
xact-028 Urine Drug Screen Laboratory Tests one table 1 T1
xact-029 PK (Glucagon) Laboratory Tests one table 1 T1
xact-030 Plasma Glucose for PD Laboratory Tests one table 1 T1
xact-031 Genetic Sample (Stored) Laboratory Tests one table 1 T1
xact-032 Anti-glucagon Antibodies Laboratory Tests one table 1 T1
xact-033 Health Outcome Instruments one table 1 T1 section
xact-034 Clarke Hypoglycemia Awareness Survey Health Outcome Instruments one table 1 T1
xact-035 Nasal and Non-nasal Score Questionnaire Health Outcome Instruments one table 1 T1
xact-036 Edinburgh Hypoglycemia Scale: Experimental Hypoglycemia Health Outcome Instruments one table 1 T1
▼ Unified Annotations 27 annotations (0% dedup from 27)
Footnote (25)
xannot_idmarkers#textscopepoints to
xannot-001 1 T1:a 1 Samples for immunogenicity, should be collected every 12 weeks (84±7 days) until the titer returns to baseline (ie, returns to within a single 2-fold dilution of the baseline titer) or until 1 year after the last dose of study treatment. A time-matched PK (glucagon) sample may be collected at the follow-up immunogenicity assessment(s) if warranted and agreed upon between both the investigator and sponsor. Additional Follow-up for TE ADA
xannot-002 2 T1:c1 1 Admission can be rescheduled if PG level is not 90 to 250 mg/dL on Day 1. Admission to CRU
xannot-003 3 T1:c2 1 Patient may be discharged 6 hours after glucagon administration. A patient may remain inpatient at the CRU at the discretion of the investigator. Discharge from CRU
xannot-004 4 T1:c3 1 After screening, medical assessment only performed to include medical review and targeted examination, as appropriate. Physical Exam
xannot-005 5 T1:c4 1 Height is at screening only. Weight on Day 1 will be collected before the start of the procedure to induce hypoglycemia. Height and Weight
xannot-007 7 T1:c6 1 Review patients’ insulin regimens to confirm acceptability to undergo the procedure to induce hypoglycemia. Collect Concomitant Medications
xannot-008 8 T1:c7 1 After completion of all PK sampling, patients will be provided a carbohydrate-rich meal. The investigator will ensure the patient’s PG is stable. A prandial insulin dose will be administered if needed. Meal
xannot-009 9 T1:c8 1 Procedures in Period 2 will occur at approximately the same time as those in Period 1. Insulin infusion is stopped once bedside PG is <60 mg/dL. Insulin infusion to Induce Hypoglycemia
xannot-010 10 T1:c9 1 Samples will be collected during the hypoglycemia induction procedure and post study treatment (up to 120 mins). Bedside PG monitoring will be conducted no more than 10 minutes apart while bedside PG is ≥90 mg/dL and no more than 5 minutes apart when bedside PG is <90 mg/dL. Bedside PG Monitoring for Safety
xannot-011 11 T1:c10 1 Once bedside PG reaches <60 mg/dL, the insulin infusion is stopped and approximately 5 minutes later study drug is administered. Indicates Time = 0 min. Study Treatment Administration
xannot-012 12 T1:c11 1 Injection-site assessment for IMG only. Injection-Site Assessment
xannot-013 13 T1:c12 1 Nasal inspection both for IMG and LY900018. Nasal Inspection
xannot-014 14 T1:c13 1 Time points may be added for each period if warranted and agreed upon between Lilly and the investigator. Predose time point will be between insulin infusion stop and study treatment. Vital Signs (Supine Blood Pressure, Pulse Rate, and Body Temperature)
xannot-015 15 T1:c14 1 Time points may be added for Period 1 and Period 2 if warranted and agreed upon between Lilly and the investigator. Predose time point will be between insulin infusion stop and study treatment. Triplicate 12-lead ECG (Central)
xannot-017 17 T1:c16 1 See Appendix 2, Clinical Laboratory Tests, for details. Patients do not need to fast for samples at screening or follow-up. At Periods 1 and 2, samples should be collected from patients who have fasted at least 8 hours before any study procedures. Clinical Lab Tests (Hematology, Clinical Chemistry, and Urinalysis) Appendix 2
xannot-018 18 T1:c17 1 Serum pregnancy test will be performed at screening. Urine pregnancy test will be performed at every admission period and follow-up visit if applicable. Pregnancy Test (Female patients of childbearing potential only)
xannot-019 19 T1:c18 1 When needed to confirm postmenopausal status. FSH (Female patients only)
xannot-020 20 T1:c19 1 Additional tests can be done at the discretion of the investigator. Ethanol Testing | Urine Drug Screen
xannot-021 21 T1:c20 1 Sampling times are relative to the time of study treatment administration (0 min). Predose time point will be between insulin infusion stop and study treatment. PK (Glucagon)
xannot-022 22 T1:c21 1 -5 mins = stop insulin infusion. Sampling times are relative to the time of study treatment administration (0 min). Predose time point will be between insulin infusion stop and study treatment. Plasma Glucose for PD
xannot-023 23 T1:c22 1 Single sample for pharmacogenetic analysis taken prior to/on Period 1 Day -1. Genetic Sample (Stored)
xannot-024 24 T1:c23 1 In the event of drug hypersensitivity reactions (immediate or non-immediate), samples will be collected as close to event onset as possible, at event resolution, and 30 days following the event. Patients with TE ADA at follow-up/ED will undergo additional follow-up. Refer to Section 9.7.1 for details. Anti-glucagon Antibodies Section 9.7.1
xannot-025 25 T1:c24 1 Sampling times are relative to the time of study treatment administration (0 min). Questionnaire will be collected in both LY900018 and IMG treatment groups in both periods. Nasal and Non-nasal Score Questionnaire
xannot-026 26 T1:c25 1 Sampling times are relative to the time of study treatment administration (0 min). During hypoglycemia induction will be when PG ≤75 mg/dL. Predose time point will be between insulin infusion stop and study treatment. Edinburgh Hypoglycemia Scale: Experimental Hypoglycemia
xannot-027 27 T1:n1 1 Note: if multiple procedures take place at the same time point, the following order of the procedure should be used: ECG, vital signs, and venipuncture. Plasma glucose sample should be collected as close as possible of protocol-specified time point. table
Source Note (2)
xannot_idmarkers#textscopepoints to
xannot-006 6 T1:c5 1 Refer to Section 9.5.5.1. Collect Hypoglycemic Events Section 9.5.5.1
xannot-016 16 T1:c15 1 See Appendix 2, Clinical Laboratory Tests, for details. Clinical Serology Tests | HbA1c Appendix 2