Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I8B-FH-ITSE | Other Identifier | Eli Lilly and Company |
Not provided
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The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 2 diabetes (T2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY900014 | Experimental | Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
|
| Insulin Lispro | Active Comparator | Participants received 100 U/mL insulin lispro (Humalog) given SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY900014 | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) | A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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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 |
|---|---|---|---|---|---|---|
| Centro Médico Viamonte | Buenos Aires | AR-C | C1120AAC | Argentina | ||
| Centro de Investigaciones Metabólicas (CINME) |
Not provided
| Label | URL |
|---|---|
| A Study of Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
The purpose of the lead-in period (prior to randomization) was to titrate basal insulin, obtain preliminary diagnostic laboratory tests, and determine baseline hypoglycemia rates. Participants were then randomized into the treatment groups in a 2:1 ratio (LY900014:insulin lispro).
The study included 8-week lead-in period followed by a 26-week treatment period.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Lispro (Humalog) Lead-in | Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| FG001 | Insulin Lispro (Humalog) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Lead-In Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2018 | Dec 17, 2021 |
Not provided
Not provided
Not provided
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| Insulin Lispro | Drug | Administered SC |
|
|
| Insulin Glargine | Drug | Administered SC |
|
| Insulin Degludec | Drug | Administered SC |
|
| Week 26 |
| 2-hour PPG Excursion During MMTT | A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares). | Week 26 |
| Rate of Severe Hypoglycemia | Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525. | Baseline through Week 26 |
| Rate of Documented Symptomatic Postmeal Hypoglycemia | Documented symptomatic postmeal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable | Baseline through Week 26 |
| Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) | 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) | Baseline, Week 26 |
| Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares). | Baseline, Week 26 |
| Change From Baseline in Insulin Dose | LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) | Baseline, Week 26 |
| Percentage of Participants With HbA1c <7% and ≤6.5% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | Week 26 |
| CABA |
| Buenos Aires |
| C1056ABJ |
| Argentina |
| Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC | Córdoba | X5008HHW | Argentina |
| Beijing Pinggu District Hospital | Beijing | Cn-11 | 101200 | China |
| Tianjin Medical University General Hospital | Tianjin | Cn-12 | 300052 | China |
| Cangzhou People's Hospital | Cangzhou | Cn-13 | 061000 | China |
| The First Hospital of Qinhuangdao | Qinhuangdao Shi | Cn-13 | 066000 | China |
| Inner Mongolia People's Hospital | Hohhot | Cn-15 | 010017 | China |
| Dalian Municipal Central Hospital Affiliated of Dalian Medical University | Dalian | Cn-21 | 116033 | China |
| Shengjing Hospital of China Medical University | Shenyang | Cn-21 | 110004 | China |
| Shanghai Putuo District Center Hospital | Shanghai | Cn-31 | 200062 | China |
| Shanghai 6th people's hospital | Shanghai | Cn-31 | China |
| The Affiliated Jiangyin Hospital of Southeast University Medical College | Jiangyin | Cn-32 | 214400 | China |
| Zhongda Hospital Southeast University | Nanjing | Cn-32 | 210009 | China |
| Nanjing Medical University - Nanjing Jiangning Hospital | Nanjing | Cn-32 | 211100 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Cn-32 | 212000 | China |
| The Third Hospital of Nanchang | Nanchang | Cn-36 | 330009 | China |
| The Central Hospital of Wuhan | Wuhan | Cn-42 | China |
| The First People's Hospital of Yueyang | Yueyang | Cn-43 | 414000 | China |
| Chongqing General Hospital | Chongqing | Cn-50 | 400014 | China |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
| Xingtai People's Hospital | Xingtai | Hebei | 054031 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Hospital of Qiqihar | Qiqihar | Heilongjiang | 161006 | China |
| The First Affiliated Hospital of Henan University of Science &Technology | Luoyang | Henan | 471003 | China |
| Wuhan Pu'ai Hospital | Wuhan | Hubei | 430000 | China |
| Yichang Central People's Hospital | Yichang | Hubei | 443003 | China |
| Chenzhou NO.1 People's Hospital | Chenzhou | Hunan | 424300 | China |
| Changzhou No.2 People's Hospital | Changzhou | Jiangsu | 213003 | China |
| The First Hospital of Nanjing | Nanjing | Jiangsu | 210012 | China |
| China-Japan Union Hospital, CJUH. | Changchun | Jilin | 130033 | China |
| Siping Central People's Hospital | Siping | Jilin | 136000 | China |
| Qinghai University Affiliated Hospital | Xining | Qinghai | 810001 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| The First Affiliated Hospital of Xi'an Medical University | Xi’an | Shanxi | China |
| Beijing Peking Union Medical College Hospital | Beijing | 100730 | China |
| Pingxiang People's Hospital | Pingxiang | 337000 | China |
| Unidad de patologia Clinica | Guadalajara | Jalisco | 44650 | Mexico |
| Centro de Inv. Medica de Occidente, SC | Zapopan | Jalisco | 45116 | Mexico |
| Unidad Médica para la Salud Integral | San Nicolás de los Garza | Mx-nle | 66465 | Mexico |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | N.L. | 64460 | Mexico |
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| FG002 | LY900014 | Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| Participants Who Received at Least One Dose |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Lispro (Humalog) | Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| BG001 | LY900014 | Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| BG002 | 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 |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. | Mean | Standard Deviation | Percentage of HbA1c |
|
| 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 | Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized Participants with baseline and at least one post-baseline HbA1c data. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 26 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) | A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares). | All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 2-hour PPG Excursion During MMTT | A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares). | All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data. | Posted | Least Squares Mean | Standard Error | mg/dL | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Severe Hypoglycemia | Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group *36525. | All randomized participants who received at least one dose of study drug. | Posted | Number | Events per 100 participant years | Baseline through Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Documented Symptomatic Postmeal Hypoglycemia | Documented symptomatic postmeal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL [3.9 millimole per liter (mmol/L)]. The rate of documented symptomatic postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable | All randomized participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | Events per participant per year | Baseline through Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) | 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) | All randomized participants with baseline and at least one post-baseline 1,5-AG data. | Posted | Least Squares Mean | Standard Error | milligram per liter (mg/L) | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares). | All randomized participants with baseline and at least one post-baseline SMBG data. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Insulin Dose | LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) | All randomized participants with baseline and at least one post-baseline basal insulin dose data. | Posted | Least Squares Mean | Standard Error | Units (U) | Baseline, Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HbA1c <7% and ≤6.5% | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. | All randomized participants with baseline and at least one post-baseline HbA1c <7% and ≤6.5% data. | Posted | Number | Percentage of participants | Week 26 |
|
|
Up to 30 weeks
All randomized participants who received at least one dose of study drug.
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 (Humalog) Lead-in | Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 0 | 628 | 17 | 628 | 29 | 628 |
| EG001 | Insulin Lispro (Humalog) | Participants received 100 U/mL insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 1 | 200 | 15 | 200 | 14 | 200 |
| EG002 | LY900014 | Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 0 | 395 | 33 | 395 | 21 | 395 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cataract diabetic | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vitreous opacities | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic complication | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Basal ganglia haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Brain stem infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2021 | Dec 17, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| D000069036 | Insulin Glargine |
| C571886 | insulin degludec |
| 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 |
| D049528 | Insulin, Long-Acting |
Not provided
Not provided
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Due to COVID 19 restrictions |
|
| Participant had taken prohibited concomitant medication |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| China |
|
| Mexico |
|
| Participants |
|
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| Participants |
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| Counts |
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| Participants |
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