ID

39376

Beskrivning

A Study of LY2605541 Versus Insulin Glargine on Blood Sugar; ODM derived from: https://clinicaltrials.gov/show/NCT01654380

Länk

https://clinicaltrials.gov/show/NCT01654380

Nyckelord

Versioner (1)
  1. 2020-01-04 2020-01-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 januari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Healthy Volunteers NCT01654380

Engelsk

Eligibility Healthy Volunteers NCT01654380

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
all participants
Beskrivning

Study Subject All

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
are healthy males or participants with t1dm
Beskrivning

Gender Healthy | Diabetes Mellitus, Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3898900
UMLS CUI [2]
C0011854
have a screening body mass index (bmi) of 20.0-29.9 kilograms per square meter (kg/m^2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
healthy participants only
Beskrivning

Healthy Volunteers

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
are overtly healthy, as determined by medical history and physical examination
Beskrivning

Healthy Volunteers Medical History | Healthy Volunteers Physical Examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C0031809
have a fasting blood glucose <108 milligrams/deciliter (mg/dl) (6.0 millimoles/liter [mmol/l]) at screening
Beskrivning

Fasting blood glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0428568
participants with t1dm only
Beskrivning

Study Subject Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0011854
have a diagnosis of t1dm for at least 1 year based on medical history
Beskrivning

Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
have a screening c-peptide <0.5 nanogram/milliliter (ng/ml)
Beskrivning

C-peptide measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202100
have a hemoglobin a1c (hba1c) of 6.0 to 9.0% at screening
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
have had no episodes of severe hypoglycemia in the past 6 months (severe hypoglycemia is defined as having neurological symptoms consistent with neuroglycopenia and having required assistance in treatment by a second party)
Beskrivning

Absence Episode of Hypoglycemia Severe | Absence Neurologic Symptoms Consistent with Neuroglycopenia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0020615
UMLS CUI [1,4]
C0205082
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0235031
UMLS CUI [2,3]
C0332290
UMLS CUI [2,4]
C0342311
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
all participants
Beskrivning

Study Subject All

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
have a hemoglobin level <12.0 grams/deciliter (g/dl) at screening
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
is currently a smoker or used tobacco products on a regular basis in the 6 months prior to screening, or intending to smoke during the study
Beskrivning

Tobacco use Regular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0205272
healthy participants only
Beskrivning

Healthy Volunteers

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
• regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen). if this situation arises, inclusion of an otherwise suitable participants may be at the discretion of the investigator
Beskrivning

Non-Prescription Drugs Regular | Prescription Drugs Regular | Exception Vitamin and Mineral Supplement | Exception Acetaminophen Infrequent | Exception Ibuprofen Infrequent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0304227
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0724359
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0000970
UMLS CUI [4,3]
C0521114
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0020740
UMLS CUI [5,3]
C0521114
participants with t1dm only
Beskrivning

Study Subject Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0011854
regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
Beskrivning

Non-Prescription Drugs Regular | Prescription Drugs Regular | Dietary Supplements Regular | Pharmaceutical Preparations Affecting Blood Glucose | Pharmaceutical Preparations Affecting Insulin Sensitivity | Pharmaceutical Preparations Promoting Weight loss

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0304227
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C0242295
UMLS CUI [3,2]
C0205272
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0005802
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0920563
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0033414
UMLS CUI [6,3]
C1262477
are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
Beskrivning

Systemic Glucocorticoids chronic | Glucocorticoid therapy by Inhalation chronic | Exception Preparations Topical | Exception Preparations Intraarticular | Exception Preparations Intraocular

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0744425
UMLS CUI [2,2]
C0205535
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C1522168
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C1522204
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C1522223
require a total daily insulin dose exceeding 100 units (u)
Beskrivning

Insulin Cumulative Dose U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0456683
have fasting triglycerides >400 mg/dl
Beskrivning

Serum fasting triglyceride measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0582824
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Similar models

Eligibility Healthy Volunteers NCT01654380

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject All
Item
all participants
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Gender Healthy | Diabetes Mellitus, Insulin-Dependent
Item
are healthy males or participants with t1dm
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0011854 (UMLS CUI [2])
Body mass index
Item
have a screening body mass index (bmi) of 20.0-29.9 kilograms per square meter (kg/m^2)
boolean
C1305855 (UMLS CUI [1])
Healthy Volunteers
Item
healthy participants only
boolean
C1708335 (UMLS CUI [1])
Healthy Volunteers Medical History | Healthy Volunteers Physical Examination
Item
are overtly healthy, as determined by medical history and physical examination
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Fasting blood glucose measurement
Item
have a fasting blood glucose <108 milligrams/deciliter (mg/dl) (6.0 millimoles/liter [mmol/l]) at screening
boolean
C0428568 (UMLS CUI [1])
Study Subject Insulin-Dependent Diabetes Mellitus
Item
participants with t1dm only
boolean
C0681850 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Insulin-Dependent Diabetes Mellitus Disease length
Item
have a diagnosis of t1dm for at least 1 year based on medical history
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C-peptide measurement
Item
have a screening c-peptide <0.5 nanogram/milliliter (ng/ml)
boolean
C0202100 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
have a hemoglobin a1c (hba1c) of 6.0 to 9.0% at screening
boolean
C0474680 (UMLS CUI [1])
Absence Episode of Hypoglycemia Severe | Absence Neurologic Symptoms Consistent with Neuroglycopenia
Item
have had no episodes of severe hypoglycemia in the past 6 months (severe hypoglycemia is defined as having neurological symptoms consistent with neuroglycopenia and having required assistance in treatment by a second party)
boolean
C0332197 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C0205082 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0235031 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C0342311 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Study Subject All
Item
all participants
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Hemoglobin measurement
Item
have a hemoglobin level <12.0 grams/deciliter (g/dl) at screening
boolean
C0518015 (UMLS CUI [1])
Tobacco use Regular
Item
is currently a smoker or used tobacco products on a regular basis in the 6 months prior to screening, or intending to smoke during the study
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Healthy Volunteers
Item
healthy participants only
boolean
C1708335 (UMLS CUI [1])
Non-Prescription Drugs Regular | Prescription Drugs Regular | Exception Vitamin and Mineral Supplement | Exception Acetaminophen Infrequent | Exception Ibuprofen Infrequent
Item
• regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen). if this situation arises, inclusion of an otherwise suitable participants may be at the discretion of the investigator
boolean
C0013231 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0304227 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0724359 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0000970 (UMLS CUI [4,2])
C0521114 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0020740 (UMLS CUI [5,2])
C0521114 (UMLS CUI [5,3])
Study Subject Insulin-Dependent Diabetes Mellitus
Item
participants with t1dm only
boolean
C0681850 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Non-Prescription Drugs Regular | Prescription Drugs Regular | Dietary Supplements Regular | Pharmaceutical Preparations Affecting Blood Glucose | Pharmaceutical Preparations Affecting Insulin Sensitivity | Pharmaceutical Preparations Promoting Weight loss
Item
regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
boolean
C0013231 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0304227 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0242295 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0005802 (UMLS CUI [4,3])
C0013227 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0920563 (UMLS CUI [5,3])
C0013227 (UMLS CUI [6,1])
C0033414 (UMLS CUI [6,2])
C1262477 (UMLS CUI [6,3])
Systemic Glucocorticoids chronic | Glucocorticoid therapy by Inhalation chronic | Exception Preparations Topical | Exception Preparations Intraarticular | Exception Preparations Intraocular
Item
are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0744425 (UMLS CUI [2,1])
C0205535 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C1522168 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C1522204 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C1522223 (UMLS CUI [5,3])
Insulin Cumulative Dose U/day
Item
require a total daily insulin dose exceeding 100 units (u)
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Serum fasting triglyceride measurement
Item
have fasting triglycerides >400 mg/dl
boolean
C0582824 (UMLS CUI [1])
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