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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-FH-ITSD | Other Identifier | Eli Lilly and Company |
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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 1 diabetes (T1D).
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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 (Humalog) | Active Comparator | Participants received 100 U/mL insulin lispro 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. It 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) as variables. | 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. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables. |
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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 |
|---|---|---|---|---|---|---|
| Centro de Investigaciones Metabólicas (CINME) | CABA | Buenos Aires | C1056ABJ | Argentina | ||
| Centro Médico Viamonte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37871985 | Derived | Ma J, Yan X, Feng Q, Liu W, Perez Manghi F, Garcia-Hernandez P, Wang G, Xu J, Yuan Y, Zhou Z. Ultra-rapid lispro improved postprandial glucose control compared to insulin lispro in predominantly Chinese patients with type 1 diabetes: A prospective, randomized, double-blind phase 3 study. Diabetes Obes Metab. 2024 Jan;26(1):311-318. doi: 10.1111/dom.15317. Epub 2023 Oct 23. |
| Label | URL |
|---|---|
| A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Lispro (Humalog) | Participants received 100 units per milliliter (U/mL) insulin lispro subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| FG001 | LY900014 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2018 | Nov 10, 2022 |
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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. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables. | 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 days. | Baseline through Week 26 |
| Rate of Documented Symptomatic Post Meal Hypoglycemia | Documented symptomatic post meal 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 post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group *365.25. | 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. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 26 |
| Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | SMBG 10-point profiles were measured at morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 26 |
| Change From Baseline in Daily Insulin Dose | LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | Baseline, Week 26 |
| Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. | Week 26 |
| CABA |
| Buenos Aires |
| C1120AAC |
| Argentina |
| Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC | Córdoba | X5008HHW | Argentina |
| The Second People's Hospital of Hefei | Hefei | Anhui | 230011 | China |
| Dongguan people's hospital | Dongguan | Guangdong | 523059 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510120 | China |
| Shantou University Medical College No.2 Affiliated Hospital | Shantou | Guangdong | 515041 | China |
| Shenzhen Second People's Hospital | Shenzhen | Guangdong | 518039 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital of Henan University of Science &Technology | Luoyang | Henan | 471003 | China |
| The First People's Hospital of Changde City | Changde | Hunan | 415003 | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
| Changzhou No.2 People's Hospital | Changzhou | Jiangsu | 213003 | China |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210000 | China |
| The First Hospital of Nanjing | Nanjing | Jiangsu | 210006 | China |
| Sir Run Run Hospital of Nanjing Medical University | Nanjing | Jiangsu | 211166 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212000 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| No.2 Hospital Affiliated to Jilin University | Changchun | Jilin | 130041 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| Jiangsu Province Hospital | Nanjing | Nanjing | 210029 | China |
| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | 200072 | China |
| West China Hospital Sichuan University | Chengdu | Sichuan | 610041 | China |
| Beijing Peking Union Medical College Hospital | Beijing | 100730 | China |
| Shanghai Putuo District Center Hospital | Shanghai | 200062 | China |
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | 200092 | China |
| Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente | Guadalajara | Jalisco | 44150 | Mexico |
| Unidad de patologia Clinica | Guadalajara | Jalisco | 44650 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | N.L. | 64460 | Mexico |
Participants received 100 U/mL LY900014 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Lispro (Humalog) | Participants received 100 U/mL insulin lispro 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 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. It 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. It 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) as variables. | 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 |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables. | 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. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables. | 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 days. | All randomized participants who received at least one dose of study drug and had baseline, at least one post-baseline hypoglycemic data. | Posted | Number | Events per 100 participant years | Baseline through Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Documented Symptomatic Post Meal Hypoglycemia | Documented symptomatic post meal 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 post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group *365.25. | All randomized participants who received at least one dose of study drug and had baseline, at least one post-baseline hypoglycemic data. | Posted | Number | 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. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All randomized participants with baseline and at least one post-baseline 1,5-AG data. | Posted | Least Squares Mean | Standard Error | milligrams 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 morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All randomized participants with baseline and at least one post-baseline SMBG data. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 26 |
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| Secondary | Change From Baseline in Daily Insulin Dose | LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment*Time (Type III sum of squares) as variables. | All randomized participants with baseline and at least one post-baseline insulin dose data. | Posted | Least Squares Mean | Standard Error | Units per day | Baseline, Week 26 |
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| Secondary | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. | All randomized participants with baseline and at least one post-baseline HbA1c data. | Posted | Number | Percentage of participants | Week 26 |
|
|
From baseline until safety follow-up (up to 30 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk 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 (Humalog) | Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 0 | 178 | 12 | 178 | 29 | 178 |
| EG001 | LY900014 | Participants received 100 U/mL LY900014 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 0 | 176 | 13 | 176 | 28 | 176 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Traumatic amputation | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic complication | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 24.1 | 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 | Jan 18, 2022 | Nov 10, 2022 | SAP_001.pdf |
Not provided
| 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 |
| 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
| Male |
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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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| China |
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| Mexico |
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| Participants |
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| Participants |
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| Participants |
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