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| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-VI-S019 | Other Identifier | Eli Lilly and Company |
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Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin lispro LM + insulin lispro MM | Experimental | Three times per day subcutaneous injection of insulin lispro mid mixture (MM) with the possibility to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved. |
|
| Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Active Comparator | Twice daily subcutaneous injection of either insulin biphasic aspart 30/70 or insulin lispro low mixture (LM) (continuation of analogue formulation used before study enrollment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Biphasic Aspart 30/70 | Drug | Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) at 16 Week Endpoint | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint | 16 weeks | |
| Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint | Baseline, 16 Weeks | |
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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. | Zagreb | HR-10000 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Lispro LM + Insulin Lispro MM | Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved. Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks. Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| insulin lispro LM | Drug | Participant adjusted dose, injected subcutaneously for 16 weeks - possibility of using instead of insulin lispro MM before evening meal if there is a risk of hypoglycemia after the dinner or high fasting glucose levels. |
|
|
| insulin lispro MM | Drug | Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks |
|
|
| insulin lispro LM | Drug | Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks |
|
|
| 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint |
Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16. |
| 16 weeks |
| Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint | Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16. | 16 weeks |
| Mean Daily Blood Glucose Values at 16 Week Endpoint | 16 weeks |
| Number of Patients With Self-reported Hypoglycemic Episodes | Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. | Baseline through 16 weeks |
| 30-Day Adjusted Rate of Hypoglycemic Events | Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. | Baseline through 16 weeks |
| Change From Baseline in Weight at 16 Week Endpoint | Baseline, 16 weeks |
| Total Daily Insulin Dose at 4 Weeks and 12 Weeks | 4 weeks and 12 weeks |
| Croatia |
| 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. | Bialystok | 15-276 | Poland |
| 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. | Rzeszów | 35-0723 | Poland |
| 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 | 020475 | 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. | Kempton Park | 1619 | South Africa |
| 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. | Kenilworth | 7708 | South Africa |
| 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. | Kuilsriver | 7580 | South Africa |
| 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. | Istanbul | 34662 | 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) |
| FG001 | Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment). Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks. Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Lispro LM + Insulin Lispro MM | Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved. Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks. Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening. |
| BG001 | Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment). Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks. Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks. |
| 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 |
| ||||||||||||||||
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
| ||||||||||||||
| Daily Dose of Antihyperglycaemic Therapy Prior to Study (International Units [IU]) | Mean | Standard Deviation | International Units (IU) |
| |||||||||||||||
| Daily Dose of Metformin Treatment Prior to Study (milligrams [mg]) | Mean | Standard Deviation | milligrams (mg) |
| |||||||||||||||
| Duration of Antihyperglycaemic Therapy Prior to Study | Mean | Standard Deviation | months |
| |||||||||||||||
| Duration of Diabetes | Mean | Standard Deviation | years |
| |||||||||||||||
| Fasting Plasma Glucose | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters (cm) |
| |||||||||||||||
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percent HbA1c |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| 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 | Hemoglobin A1c (HbA1c) at 16 Week Endpoint | Number of patients who received at least one dose of study drug and had an HbA1c measure at endpoint. | Posted | Mean | Standard Deviation | percent HbA1c | 16 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving Hemoglobin A1c (HbA1c) <7% and HbA1c ≤6.5% at 16 Week Endpoint | Number of patients who received at least one dose of study drug and had a post-baseline HbA1c value at endpoint. | Posted | Number | percentage of participants | 16 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) at 16 Week Endpoint | Number of patients who received at least one dose of study drug and a post-baseline HbA1c value at endpoint. | Posted | Mean | Standard Deviation | percent HbA1c | Baseline, 16 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 2-hour Postprandial Plasma Glucose Concentrations After the Midday Meal From Self-monitored 7-point Plasma Glucose at 16 Week Endpoint | Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the blood glucose concentrations 2-hours after the midday meal at Week 16. | Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial plasma glucose reading after the midday meal at week 16. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | 16 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean 2-hour Postprandial Blood Glucose Excursions After Midday Meal at 16 Week Endpoint | Participants self-monitored their blood glucose concentrations at 7 time points: three premeal and three 2-hour postprandial meal measurements for the morning (breakfast), midday (lunch), and evening (dinner) meals, as well as a 3:00 AM measurement. Results presented here are for the difference (excursion) between midday premeal and 2-hour postprandial midday meal blood glucose concentrations at Week 16. | Number of patients who received at least one dose of study drug and had a post-baseline 2-hour postprandial blood glucose reading after the midday meal at week 16. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | 16 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Daily Blood Glucose Values at 16 Week Endpoint | Number of patients who received at least one dose of study drug and had a post-baseline blood glucose reading at week 16 for the respective variable. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | 16 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Self-reported Hypoglycemic Episodes | Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. | Number of patients who received at least one dose of study drug and had at least one assessment after randomization. | Posted | Number | participants | Baseline through 16 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 30-Day Adjusted Rate of Hypoglycemic Events | Hypoglycemia: any time a patient feels, or another person observes, that patient is experiencing a sign/symptom that he or she would associate with hypoglycemia or a plasma-equivalent glucose measurement ≤70 mg/dL. Nocturnal hypoglycemia: hypoglycemia occurring after bedtime and prior to morning meal and morning dose of insulin or metformin. Severe hypoglycemia: hypoglycemia where patient requires assistance from another person and which is associated with either a blood glucose level less than 50 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration. | Number of patients who received at least one dose of study drug and had at least one assessment after randomization. | Posted | Mean | Standard Deviation | number of events per 30 days | Baseline through 16 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Weight at 16 Week Endpoint | Number of patients who received at least one dose of study drug and had at least one post-baseline weight value at week 16. | Posted | Mean | Standard Deviation | kilograms (kg) | Baseline, 16 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Daily Insulin Dose at 4 Weeks and 12 Weeks | Number of patients who received at least one dose of study drug and had a post-baseline insulin measurement at week 4 and week 12. | Posted | Mean | Standard Deviation | International Units (IU) | 4 weeks and 12 weeks |
|
|
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 LM + Insulin Lispro MM | Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved. Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks. Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening. | 3 | 139 | 26 | 139 | ||
| EG001 | Insulin Biphasic Aspart 30/70 or Insulin Lispro LM | Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment). Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks. Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks. | 7 | 139 | 26 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment | One myocardial infarction resulted in death during the study. However, another patient had a fatal myocardial infarction after study completion but within the 30 day follow-up window for adverse events after completion. |
|
| Gangrene | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Genital candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Carpal tunnel decompression | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Dental care | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Eye laser surgery | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza immunisation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetic vascular disorder | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Venous insufficiency | Vascular disorders | MedDRA 12.0 | 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 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
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| African |
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| Croatia |
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| Turkey |
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| Romania |
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| South Africa |
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| Hungary |
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| Biphasic Insulin Aspart 30/70 Dose (n=90, n=94) |
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| Premixed Insulin Analogue Treatment |
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| Oral Hypoglycemic Treatment |
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