Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-MC-IOPW | Other Identifier | Eli Lilly and Company |
Not provided
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Patients will continue to use their current insulin pump for this study. Patients will receive insulin lispro and insulin aspart during this study. One medication will be taken for 12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor will know which medication is being taken at any time. The order in which the two medications are taken will be determined by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Lispro 6 Day (6D) | Experimental |
| |
| Insulin Aspart 6 Day (6D) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Lispro 6 Day (6D) | Drug | Administered by infusion pump for 12 week treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use | Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean SMBG | Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D. | Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period |
| Mean Daily Insulin Dose (Total, Basal, and Bolus) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) | Baseline, endpoint for each 12-week treatment period | |
| Percentage of Participants Having a Hyperglycemic Episode | A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [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 |
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, 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. | Caen | 14033 |
Not provided
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lispro 6D/Aspart 6D | Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks. |
| FG001 | Aspart 6D/Lispro 6D | Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1-First Treatment Intervention |
|
| ||||||||||||||||||||||||
| Period 2-Second Treatment Intervention |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Lispro 6D/Aspart 6D | Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks. |
| BG001 | Aspart 6D/Lispro 6D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and 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) | Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12) |
|
Not provided
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| 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 6D | Insulin Lispro 6D administered by infusion pump for 12 week treatment period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
Input to primary endpoint measurements (SMBG) contained approximately 40% missing data. Several analyses to account for missing data were conducted and results from these additional analyses were consistent with results from the original analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic 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 |
Not provided
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| Insulin Aspart 6 Day (6D) | Drug | Administered by infusion pump for 12 week treatment period |
|
| Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
| Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values | Baseline, endpoint for each 12-week treatment period |
| Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% | Endpoint for each 12-week treatment period |
| Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
| 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 millimoles per liter [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. | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
| Percentage of Participants With Pump Complications | Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, 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 the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change. | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
| Pump Complications Rate Per 30 Days | Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, 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 the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change. | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
| Percentage of Participants Having a Hypoglycemic Episode | A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L). All Reported Hypoglycemic Episodes are defined as an event which is associated with
| All days for each reservoir cycle throughout each 12-week treatment period |
| Hypoglycemic Episode Rate Per 30 Days | All Reported Hypoglycemic Episodes are defined as an event which is associated with
| All days for each reservoir cycle throughout each 12-week treatment period |
| Change From Baseline to 12 Week Endpoint for Each Treatment in Weight | Baseline, endpoint for each 12-week treatment period |
| Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure | Baseline, endpoint for each 12-week treatment period |
| France |
| 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. | Corbeil-Essonnes | 91106 | France |
| 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. | La Rochelle | 17019 | France |
| 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. | Marseille | 13009 | France |
| 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. | Montpellier | 34295 | France |
| 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. | Narbonne | 11108 | France |
| 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. | Ludwigshafen | 67059 | Germany |
| 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. | Mainz | 55116 | Germany |
| 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. | Münster | 48145 | Germany |
| 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. | Neuwied | 56564 | Germany |
| 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. | Potsdam | 14469 | Germany |
| 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. | Békéscsaba | 5600 | Hungary |
| 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. | Budapest | 1023 | Hungary |
| 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. | Nyíregyháza | 4400 | Hungary |
| 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. | Zalaegerszeg | 8900 | Hungary |
| Withdrawal by Subject |
|
| Physician Decision |
|
| NOT COMPLETED |
|
|
Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Insulin Aspart 6D administered by infusion pump for 12 week treatment period
|
|
|
| Secondary | Mean SMBG | Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D. | All randomized participants who completed at least one post-randomization visit and one SMBG measurement on a Day 6, or Day 2 depending on the analysis, for the respective treatment arm: insulin lispro 6D and insulin aspart 6D. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period |
|
|
|
|
| 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 | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks for Each Treatment in Glycated 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 HbA1c | Baseline, endpoint for each 12-week treatment period |
|
|
|
|
| Secondary | Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (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 | Endpoint for each 12-week treatment period |
|
|
|
|
| Other Pre-specified | Change From Baseline to 12 Weeks for 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 | Baseline, endpoint for each 12-week treatment period |
|
|
|
|
| Other Pre-specified | Percentage of Participants Having a Hyperglycemic Episode | A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [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 | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
|
|
|
| Other Pre-specified | 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 millimoles per liter [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 | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
|
|
|
|
| Other Pre-specified | Percentage of Participants With Pump Complications | Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, 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 the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a 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 | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
|
|
|
|
| Other Pre-specified | Pump Complications Rate Per 30 Days | Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, 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 the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a 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 | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
|
|
|
|
| Other Pre-specified | Percentage of Participants Having a Hypoglycemic Episode | A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L). All Reported Hypoglycemic Episodes are defined as an event which is 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 | All days for each reservoir cycle throughout each 12-week treatment period |
|
|
|
|
| Other Pre-specified | Hypoglycemic Episode Rate Per 30 Days | All Reported Hypoglycemic Episodes are defined as an event which is 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 | All days for each reservoir cycle throughout each 12-week treatment period |
|
|
|
|
| Other Pre-specified | Change From Baseline to 12 Week 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, endpoint for each 12-week treatment period |
|
|
|
|
| Other Pre-specified | Change From Baseline to 12 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 | millimeters of mercury (mmHg) | Baseline, endpoint for each 12-week treatment period |
|
|
|
|
| 3 |
| 127 |
| 34 |
| 127 |
| EG001 | Insulin Aspart 6D | Insulin Aspart 6D administered by infusion pump for 12 week treatment period | 7 | 127 | 31 | 127 |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment | These events were severe hypoglycemic events. |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Tracheobronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Uterine infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Open wound | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Microalbuminuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Lipohypertrophy | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Atherectomy | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Injection | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| SMBG Day 6 (N=124, 124) |
|
| Least Squares Mean Difference |
| 0.42 |
| 2-Sided |
| 95 |
| 0.25 |
| 0.58 |
Least Squares Mean Difference = Insulin Lispro 6 Day (Day 6) minus Insulin Lispro 6 Day (Day 2); adjusted for DayGroup + Period + Baseline HbA1c |
| Yes |
| Non-Inferiority or Equivalence |
Non-inferiority margin of 0.6 mmol/L was used. |
| Daily Bolus Insulin (N=116, 117) |
|
| Least Squares Mean Difference |
| 0.02 |
| 2-Sided |
| 95 |
| -0.26 |
| 0.31 |
Daily Basal Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose |
| No |
| Superiority or Other |
| Least Squares Mean Difference | 0.23 | 2-Sided | 95 | -0.15 | 0.60 | Daily Bolus Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose | No | Superiority or Other |
| Odds Ratio (OR) |
| 0.36 |
| 2-Sided |
| 95 |
| 0.20 |
| 0.63 |
Odds Ratio of HbA1c <7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day. |
| No |
| Superiority or Other |
| Bolus Insulin Dose (N=112, 112) |
|
| 0.506 |
P-value for Basal Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Basal Dose. |
| 95 |
| No |
| Superiority or Other |
| Crossover Model | 0.790 | P-value for Bolus Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Bolus Dose. | 95 | No | Superiority or Other |
| Gart's Test |
| 0.472 |
P-value for overall pump complications associated with a premature infusion set change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used. |
| 95 |
| No |
| Superiority or Other |
| 0.499 |
P-value for Premature Infusion Set Change computed using negative binomial test including factors for treatment, period and sequence. |
| 95 |
| No |
| Superiority or Other |
| 0.894 |
P-value for Diastolic Blood Pressure (DBP) computed using crossover model. Response = treatment + sequence + period + baseline diastolic blood pressure. |
| 95 |
| No |
| Superiority or Other |