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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IOPV | Other Identifier | Eli Lilly and Company |
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This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of this study is to provide information on the use of insulin lispro in insulin pumps (Continuous Subcutaneous Insulin Infusion [CSII]) compared to insulin aspart over 6 days of pump reservoir in-use. The study will also compare the in-use characteristics of insulin lispro infused at 6 days with insulin lispro infused at 2 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Lispro 2 Day | Active Comparator |
| |
| Insulin Lispro 6 Day | Experimental |
| |
| Insulin Aspart 6 Day | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin lispro 2 day reservoir in-use | Drug | Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use | 8 weeks of each treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean SMBG | Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day. | 8 weeks for each treatment |
| Mean Daily Insulin Dose (Total, Basal, and Bolus) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9am - 5pm Eastern (UTC/GMT - 5hrs, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Concord | California | 94520 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A (L2D/L6D/A6D) | Participants received Insulin Lispro 2D (L2D (Days)), Insulin Lispro 6D (L6D) and Insulin Aspart 6D (A6D) as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D |
| FG001 | Sequence B (L2D/A6D/L6D) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Period 1 |
|
Not provided
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| Insulin lispro 6 day reservoir in-use | Drug | Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period. |
|
|
| Insulin aspart 6 day reservoir in-use | Drug | Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period. |
|
| 8 weeks for each treatment |
| Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values | Baseline, 8 weeks for each treatment |
| Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7% | 8 weeks for each treatment |
| Percentage of Participants With Hyperglycemia | Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. | 8 weeks for each treatment |
| Hyperglycemic Episode Rate Per 30 Days | Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days. | 8 weeks for each treatment |
| Percentage of Participants With Pump Complications | Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change. | 8 weeks for each treatment |
| Pump Complication Rate Per 30 Days | Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change. | 8 weeks for each treatment |
| Percentage of Participants With Hypoglycemia | Hypoglycemia was defined as an event which was associated with
| 8 weeks for each treatment |
| Hypoglycemia Episode Rate Per 30 Days | Hypoglycemia was defined as an event which was associated with
| 8 weeks for each treatment |
| Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight | Baseline, 8 weeks for each treatment |
| Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure | Baseline, 8 weeks for each treatment |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aurora | Colorado | 80045 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hollywood | Florida | 33021 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | West Palm Beach | Florida | 33401 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Idaho Falls | Idaho | 83404 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Topeka | Kansas | 66606 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nashua | New Hampshire | 03063 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Albany | New York | 12206 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Syracuse | New York | 13210 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Asheville | North Carolina | 28803 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Austin | Texas | 78731 | United States |
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D. |
| FG002 | Sequence C (L6D/L2D/A6D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D. |
| FG003 | Sequence D (L6D/A6D/L2D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D. |
| FG004 | Sequence E (A6D/L2D/L6D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D. |
| FG005 | Sequence F (A6D/L6D/L2D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Study Period 2 |
|
|
| Study Period 3 |
|
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A (L2D/L6D/A6D) | Participants received Insulin Lispro 2D (2 Days), Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D. |
| BG001 | Sequence B (L2D/A6D/L6D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D. |
| BG002 | Sequence C (L6D/L2D/A6D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D. |
| BG003 | Sequence D (L6D/A6D/L2D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D. |
| BG004 | Sequence E (A6D/L2D/L6D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D. |
| BG005 | Sequence F (A6D/L6D/L2D) | Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use | All randomized participants who completed at least one post-randomization visit. Those included in the Primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | 8 weeks of each treatment |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean SMBG | Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day. | All randomized participants who completed at least one post-randomization visit and one SMBG measurement on Day 2 for insulin lispro 2 day or Day 6 for the respective treatment arm: insulin lispro 6 day and insulin aspart 6 day. | Posted | Mean | Standard Deviation | mmol/L | 8 weeks for each treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Daily Insulin Dose (Total, Basal, and Bolus) | All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose. | Posted | Mean | Standard Deviation | Units (U) of insulin | 8 weeks for each treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values | All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, 8 weeks for each treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7% | All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period. | Posted | Number | participants | 8 weeks for each treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hyperglycemia | Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. | All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia. | Posted | Number | percentage of participants | 8 weeks for each treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hyperglycemic Episode Rate Per 30 Days | Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days. | All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia. | Posted | Mean | Standard Deviation | hyperglycemic episodes per 30 days | 8 weeks for each treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Pump Complications | Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change. | All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications. | Posted | Number | percentage of participants | 8 weeks for each treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pump Complication Rate Per 30 Days | Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change. | All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications. | Posted | Mean | Standard Deviation | pump complications per 30 days | 8 weeks for each treatment |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Hypoglycemia | Hypoglycemia was defined as an event which was associated with
| All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia. | Posted | Number | percentage of participants | 8 weeks for each treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypoglycemia Episode Rate Per 30 Days | Hypoglycemia was defined as an event which was associated with
| All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia. | Posted | Mean | Standard Deviation | hypoglycemic episodes per 30 days | 8 weeks for each treatment |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight | All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period. | Posted | Mean | Standard Deviation | kilograms (kg) | Baseline, 8 weeks for each treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure | All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period. | Posted | Mean | Standard Deviation | mmHg | Baseline, 8 weeks for each treatment |
|
|
Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Lispro 2 Day | Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period. | 3 | 122 | 71 | 122 | ||
| EG001 | Insulin Lispro 6 Day | Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks. | 8 | 127 | 68 | 127 | ||
| EG002 | Insulin Aspart 6 Day | Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks. | 10 | 124 | 71 | 124 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophagitis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment | These events were severe hypoglycemic events. |
|
| Cervical myelopathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Infusion site haemorrhage | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Infusion site mass | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Urine ketone body present | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis seasonal | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vulvovaginal Mycotic Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Smear Cervix Abnormal | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
Input to primary endpoint measurements (SMBG) contained approximately 40% missing data. Several analyses to account for missing data have been conducted and results from these additional analyses were consistent with results of original analysis.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Withdrawal by Subject |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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