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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-EW-S020 | Other Identifier | Eli Lilly and Company | |
| CTRI/2009/091/000609 | Registry Identifier | India Registry |
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This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glargine | Active Comparator | Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs) |
|
| Premixed Insulin Lispro | Experimental | Premixed Insulin Lispro (mid-mixture or low-mixture) 1,2 or 3 injections plus OAMs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint | Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Using Each Possible Final Insulin Regimen | Insulin Regimens: Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro. |
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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 |
|---|---|---|---|---|---|---|
| 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. | Smiths Falls | Ontario | K7A 4W8 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glargine | Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs) |
| FG001 | Premix Insulin Lispro | Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Insulin Lispro Premix (mid-mixture and low-mixture) | Drug | patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks |
|
|
| 48 weeks |
| HbA1c Over Time | Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit*treatment in Full Analysis Set (FAS) Population. | 16 weeks, 32 weeks, and 48 weeks |
| Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time | 16 weeks, 32 weeks and 48 weeks |
| 7-point Self-monitored Blood Glucose Profiles | 16 weeks, 32 weeks and 48 weeks |
| Mean Postprandial Blood Glucose Values | Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase. | Baseline, 16 weeks, 32 weeks and 48 weeks |
| Mean Daily Total, Basal and Prandial Insulin Dose | 16 weeks, 32 weeks and 48 weeks |
| Body Weight Change From Baseline to Endpoint | baseline, 48 weeks |
| Incidence of All Self-reported Hypoglycemic Episodes | Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). | Baseline to 48 weeks |
| Rate Per 30 Days of All Self-reported Hypoglycemic Episodes | The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days). | Baseline to 48 weeks |
| Number of Participants With Adverse Events | A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module. TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline. | Baseline to 48 weeks |
| Canada |
| 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. | Alexandria | Egypt |
| 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. | Bāb al Lūq | Egypt |
| 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. | Cairo | 11562 | Egypt |
| 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. | Heliopolis | Egypt |
| 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. | Ahmedabad | 380006 | India |
| 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. | Hyderabaad | 500033 | India |
| 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. | Indore | 452001 | India |
| 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. | Mumbai | 400053 | India |
| 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. | Coatzacoalcos | 96400 | Mexico |
| 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. | Mexico City | 06700 | Mexico |
| 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. | Aveiro | 3814-501 | Portugal |
| 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. | Barreiro | 2830 | Portugal |
| 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. | Lisbon | 1250-203 | Portugal |
| 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. | Porto | 4099-001 | Portugal |
| 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. | Bucharest | 020359 | Romania |
| 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. | Craiova | 200000 | Romania |
| 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. | Galati | 6200 | Romania |
| 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. | Iași | 70057 | Romania |
| 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. | Alicante | 03114 | Spain |
| 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. | Badalona | 08915 | Spain |
| 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. | Madrid | 28040 | Spain |
| 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. | Palma de Mallorca | 07198 | Spain |
| 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. | Santa Cruz de Tenerife | 38320 | Spain |
| 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. | Ankara | 06510 | Turkey (Türkiye) |
| 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. | Antalya | 07070 | Turkey (Türkiye) |
| 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. | Konya | 42075 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Glargine | Glargine +/- 1,2 or 3 injections of insulin lispro plus oral antihyperglycemic medications (OAMs) |
| BG001 | Premix Insulin Lispro | Premixed Insulin Lispro (mid-mixture or low-mixture)1,2 or 3 injections plus OAMs |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Glycosylated Hemoglobin (HbA1c) | Mean | Standard Deviation | percent glycosylated hemoglobin |
|
| 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 | Baseline Adjusted Glycosylated Hemoglobin (HbA1c) at Endpoint | Least Squares Mean (LSMean) values were adjusted based on a fixed effect linear regression model: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) in per-protocol (PP) population. | PP Population=All participants who were randomized and met following criteria during study:
| Posted | Least Squares Mean | 95% Confidence Interval | percent glycosylated hemoglobin | 48 weeks |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Using Each Possible Final Insulin Regimen | Insulin Regimens: Lispro: Mid-Mix (MM) before noon; Low-Mix (LM) before evening (PM); MM before noon+LM before PM; LM before morning (AM)+MM before noon + LM before PM; MM before AM +MM before noon+LM before PM Glargine: Glargine once a day (QD); Glargine QD + 1 Lispro (noon or PM); Glargine QD + 2 Lispro (noon and PM); Glargine QD + 3 Lispro. | Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had a measurement for the dependent variable at the time point, according to intent-to-treat (ITT) principles. | Posted | Number | percentage of participants | 48 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | HbA1c Over Time | Least Squares Mean (LSMean) values were adjusted based on a mixed effect linear regression model with a participant specific random effect: HbA1c = Treatment + Country + HbA1c baseline value + Ramadan holiday between Visit 10 (Week 36) and Visit 12 (Week 48) (yes/no) + visit + visit*treatment in Full Analysis Set (FAS) Population. | Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles. | Posted | Least Squares Mean | 95% Confidence Interval | percent glycosylated hemoglobin | 16 weeks, 32 weeks, and 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving HbA1c Less Than or Equal to 6.5% and Less Than or Equal to 7% Over Time | Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles. | Posted | Number | percentage of participants | 16 weeks, 32 weeks and 48 weeks |
|
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| Secondary | 7-point Self-monitored Blood Glucose Profiles | Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles. | Posted | Least Squares Mean | Standard Error | millimoles per Liter (mmol/L) | 16 weeks, 32 weeks and 48 weeks |
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| Secondary | Mean Postprandial Blood Glucose Values | Mean postprandial blood glucose values were assessed using GlycoMark, which is an FDA-approved blood test measuring levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma. When 1,5 AG values decrease, serum glucose levels increase. | Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles. | Posted | Mean | Standard Deviation | microgram per milliliter (µg/mL) | Baseline, 16 weeks, 32 weeks and 48 weeks |
|
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| Secondary | Mean Daily Total, Basal and Prandial Insulin Dose | Full Analysis Set: All participants who enrolled in this study, completed Screening, were randomized to one of the study treatments, and had at least one post baseline measurement for the dependent variable, according to intent-to-treat (ITT) principles. | Posted | Mean | Standard Deviation | International Units per day (IU/day) | 16 weeks, 32 weeks and 48 weeks |
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| Secondary | Body Weight Change From Baseline to Endpoint | Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | kilograms (kg) | baseline, 48 weeks |
|
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| Secondary | Incidence of All Self-reported Hypoglycemic Episodes | Percentage of participants with self-reported hypoglycemic episodes at any time during the study. A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose level of ≤70 mg/dL (3.9 mmol/L) (Roche plasma glucose) or ≤75 mg/dL (4.2 mmol/L) (IFCC Plasma Values), even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). | Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint. | Posted | Number | percentage of participants | Baseline to 48 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate Per 30 Days of All Self-reported Hypoglycemic Episodes | The hypoglycemia rate between two visits will be calculated as the total number of episodes between the two visits divided by the number of days between the visits, and then multiplied by 30 days (rate per patient per 30 days). | Safety Set Population: All participants who received at least one dose of study drug during the treatment period and had measurement at baseline and endpoint. | Posted | Mean | Standard Deviation | episodes per 30 days | Baseline to 48 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | A summary of serious adverse events (SAEs) and all other non-serious treatment-emergent adverse events (TEAE) is located in the Reported Adverse Event Module. TEAEs are defined as events that are newly reported after randomization or reported to worsen in severity from baseline. | Safety Set Population: All participants who received at least one dose of study drug during the treatment period. | Posted | Number | participants | Baseline to 48 weeks |
|
|
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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 | Premix Insulin Lispro | Premixed Insulin Lispro (mid-mixture or low-mixture) 1, 2 or 3 injections plus OAMs | 7 | 169 | 52 | 169 | ||
| EG001 | Glargine | Glargine +/- 1, 2 or 3 injections of insulin lispro plus OAMs | 3 | 173 | 53 | 173 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Castleman's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 14.0 | Systematic Assessment |
| |
| Amputation | Surgical and medical procedures | 14.0 | Systematic Assessment |
| |
| Transurethral prostatectomy | Surgical and medical procedures | 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 14.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 14.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 14.0 | Systematic Assessment |
| |
| Pain | General disorders | 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 14.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | 14.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 14.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 14.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | 14.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 14.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | 14.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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 |
|---|---|
| D000069036 | Insulin Glargine |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-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 |
| D061266 | Insulin, Short-Acting |
Not provided
Not provided
| Male |
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| African |
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| Hispanic |
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| East Asian |
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| West Asian |
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| Egypt |
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| Mexico |
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| Canada |
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| Spain |
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| Romania |
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| Turkey |
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| India |
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| Brazil |
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