ID

38951

Beskrivning

Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects and Male Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01686945

Länk

https://clinicaltrials.gov/show/NCT01686945

Nyckelord

Versioner (1)
  1. 2019-11-15 2019-11-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 november 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes NCT01686945

Engelsk

Eligibility Diabetes NCT01686945

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01686945
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and laboratory safety tests performed during the screening visit, as judged by the investigator. this also applies to subjects with t2d, except for the underlying diabetes with or without associated hyperlipidaemia and/or hypertension
Beskrivning

Gender | General health good Medical History | General health good Physical Examination | General health good Vital signs finding | General health good ECG | General health good Laboratory Procedures | Study Subject Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1277245
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C1277245
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C1277245
UMLS CUI [4,2]
C1290982
UMLS CUI [5,1]
C1277245
UMLS CUI [5,2]
C1623258
UMLS CUI [6,1]
C1277245
UMLS CUI [6,2]
C0022885
UMLS CUI [7,1]
C0681850
UMLS CUI [7,2]
C0011860
body mass index (bmi): a) healthy subjects: above or equal to 20 and below 30 kg/m^2. b) subjects with t2d: bmi above or equal to 20 and below or equal to 37 kg/m^2
Beskrivning

Body mass index | Healthy Volunteers | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C1708335
UMLS CUI [3]
C0011860
glycosylated haemoglobin (hba1c): a) healthy subjects: below 6.0%. b) subjects with t2d: between 6.5 and 9.0% (both inclusive)
Beskrivning

Hemoglobin A1c measurement | Healthy Volunteers | Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C1708335
UMLS CUI [3]
C0011860
additional inclusion criterion only for subjects with t2d: male subjects with t2d (diagnosed within the past 10 years) treated with diet and exercise and/or who have been on stable doses of metformin for at least 12 weeks prior to visit 3 (day -1 or 0) and for whom no changes in treatment are planned for the trial period
Beskrivning

Study Subject Non-Insulin-Dependent Diabetes Mellitus | Gender | Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Exercise | Metformin Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0011860
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0011860
UMLS CUI [3,2]
C0872146
UMLS CUI [4]
C0012159
UMLS CUI [5]
C0015259
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of, or presence of, cancer, diabetes (only for healthy subjects) or any clinically significant cardiovascular (only for healthy subjects), respiratory, metabolic, renal, hepatic, gastro-intestinal (gi), endocrinological (except diabetes in subjects with t2d), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
Beskrivning

Malignant Neoplasms | Diabetes Mellitus | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0017178
UMLS CUI [9]
C0014130
UMLS CUI [10]
C0018939
UMLS CUI [11]
C0037274
UMLS CUI [12]
C0036916
UMLS CUI [13]
C0027765
UMLS CUI [14]
C0004936
UMLS CUI [15,1]
C0012634
UMLS CUI [15,2]
C0205164
blood pressure in supine position at the screening examination above: a) 140 mmhg systolic and/or above 90 mmhg diastolic for healthy subjects. b) 160 mmhg systolic and/or above 95 mmhg diastolic for subjects with t2d
Beskrivning

Lying systolic blood pressure | Lying diastolic blood pressure | Healthy Volunteers | Study Subject Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C1319895
UMLS CUI [2]
C1319896
UMLS CUI [3]
C1708335
UMLS CUI [4,1]
C0681850
UMLS CUI [4,2]
C0011860
use of prescription or non-prescription medicinal products (except routine vitamins) within three weeks preceding the dosing. occasional use of paracetamol or acetylsalicylic acid is permitted. a. for subjects with t2d: any other current diabetes treatment apart from metformin (e.g. treatment with incretin mimetics, dipeptidyl peptidase-iv (dpp-iv) inhibitors, insulin secretagogues, insulin or thiazolidinediones (tzds)). use of blood lipidregulating agents, as well as blood pressure regulating, and thrombo-embolic agents is allowed
Beskrivning

Prescribed medications | Drugs, Non-Prescription | Exception Standard Vitamins | Diabetes Therapy Except Metformin | Incretin mimetic | Dipeptidyl Peptidase 4 Inhibitors | Pills Releasing Insulin | Insulin | Thiazolidinediones

Datatyp

boolean

Alias
UMLS CUI [1]
C3166216
UMLS CUI [2]
C0013231
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1442989
UMLS CUI [3,3]
C0042890
UMLS CUI [4,1]
C3274787
UMLS CUI [4,2]
C0332300
UMLS CUI [4,3]
C0025598
UMLS CUI [5]
C1562104
UMLS CUI [6]
C2917254
UMLS CUI [7,1]
C0994475
UMLS CUI [7,2]
C1283071
UMLS CUI [7,3]
C0021641
UMLS CUI [8]
C0021641
UMLS CUI [9]
C1257987
exclusion criteria only for subjects with t2d:
Beskrivning

Exclusion Criteria Non-Insulin-Dependent Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0011860
proliferative retinopathy or maculopathy requiring acute treatment as determined by funduscopy/fundus photography and judged by the investigator. if subject presents a medical certificate for funduscopy/fundus photography performed within last 3 months this can substitute the funduscopy/fundus photography at screening
Beskrivning

Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for | Ophthalmoscopy | Fundus photography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
UMLS CUI [3]
C0029090
UMLS CUI [4]
C0200189
nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (egfr) below 60. the egfrshould be determined using the modification of diet in renal disease 4-variable method encompassing creatinine, age, gender, and race
Beskrivning

Kidney Disease Stage | Renal function GFR estimation by MDRD

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C1306673
UMLS CUI [2]
C2170215
diabetic peripheral neuropathy using the 10 g semmes-weinstein monofilament examination at the great toe or plantar aspect of the fifth metatarsal
Beskrivning

Diabetic peripheral neuropathy | Semmes Weinstein Monofilament Examination Hallux | Semmes Weinstein Monofilament Examination Fifth metatarsal Plantar

Datatyp

boolean

Alias
UMLS CUI [1]
C0740447
UMLS CUI [2,1]
C4288244
UMLS CUI [2,2]
C0018534
UMLS CUI [3,1]
C4288244
UMLS CUI [3,2]
C0459705
UMLS CUI [3,3]
C0230463
clinically significant active cardiovascular disease including history of myocardial infarction and/or heart failure (new york heart association (nyha) class iii and iv1) at the discretion of the investigator
Beskrivning

Cardiovascular Disease | Myocardial Infarction | Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
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Similar models

Eligibility Diabetes NCT01686945

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01686945
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | General health good Medical History | General health good Physical Examination | General health good Vital signs finding | General health good ECG | General health good Laboratory Procedures | Study Subject Non-Insulin-Dependent Diabetes Mellitus
Item
male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and laboratory safety tests performed during the screening visit, as judged by the investigator. this also applies to subjects with t2d, except for the underlying diabetes with or without associated hyperlipidaemia and/or hypertension
boolean
C0079399 (UMLS CUI [1])
C1277245 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C1277245 (UMLS CUI [4,1])
C1290982 (UMLS CUI [4,2])
C1277245 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C1277245 (UMLS CUI [6,1])
C0022885 (UMLS CUI [6,2])
C0681850 (UMLS CUI [7,1])
C0011860 (UMLS CUI [7,2])
Body mass index | Healthy Volunteers | Diabetes Mellitus, Non-Insulin-Dependent
Item
body mass index (bmi): a) healthy subjects: above or equal to 20 and below 30 kg/m^2. b) subjects with t2d: bmi above or equal to 20 and below or equal to 37 kg/m^2
boolean
C1305855 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Hemoglobin A1c measurement | Healthy Volunteers | Diabetes Mellitus, Non-Insulin-Dependent
Item
glycosylated haemoglobin (hba1c): a) healthy subjects: below 6.0%. b) subjects with t2d: between 6.5 and 9.0% (both inclusive)
boolean
C0474680 (UMLS CUI [1])
C1708335 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
Study Subject Non-Insulin-Dependent Diabetes Mellitus | Gender | Non-Insulin-Dependent Diabetes Mellitus Disease length | Diet therapy | Exercise | Metformin Dose Stable
Item
additional inclusion criterion only for subjects with t2d: male subjects with t2d (diagnosed within the past 10 years) treated with diet and exercise and/or who have been on stable doses of metformin for at least 12 weeks prior to visit 3 (day -1 or 0) and for whom no changes in treatment are planned for the trial period
boolean
C0681850 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0011860 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C0012159 (UMLS CUI [4])
C0015259 (UMLS CUI [5])
C0025598 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Diabetes Mellitus | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Endocrine System Diseases | Hematological Disease | Dermatologic disorders | Sexually Transmitted Diseases | Nervous system disorder | Mental disorders | Disease Major
Item
history of, or presence of, cancer, diabetes (only for healthy subjects) or any clinically significant cardiovascular (only for healthy subjects), respiratory, metabolic, renal, hepatic, gastro-intestinal (gi), endocrinological (except diabetes in subjects with t2d), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
boolean
C0006826 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0014130 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0037274 (UMLS CUI [11])
C0036916 (UMLS CUI [12])
C0027765 (UMLS CUI [13])
C0004936 (UMLS CUI [14])
C0012634 (UMLS CUI [15,1])
C0205164 (UMLS CUI [15,2])
Lying systolic blood pressure | Lying diastolic blood pressure | Healthy Volunteers | Study Subject Non-Insulin-Dependent Diabetes Mellitus
Item
blood pressure in supine position at the screening examination above: a) 140 mmhg systolic and/or above 90 mmhg diastolic for healthy subjects. b) 160 mmhg systolic and/or above 95 mmhg diastolic for subjects with t2d
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
C1708335 (UMLS CUI [3])
C0681850 (UMLS CUI [4,1])
C0011860 (UMLS CUI [4,2])
Prescribed medications | Drugs, Non-Prescription | Exception Standard Vitamins | Diabetes Therapy Except Metformin | Incretin mimetic | Dipeptidyl Peptidase 4 Inhibitors | Pills Releasing Insulin | Insulin | Thiazolidinediones
Item
use of prescription or non-prescription medicinal products (except routine vitamins) within three weeks preceding the dosing. occasional use of paracetamol or acetylsalicylic acid is permitted. a. for subjects with t2d: any other current diabetes treatment apart from metformin (e.g. treatment with incretin mimetics, dipeptidyl peptidase-iv (dpp-iv) inhibitors, insulin secretagogues, insulin or thiazolidinediones (tzds)). use of blood lipidregulating agents, as well as blood pressure regulating, and thrombo-embolic agents is allowed
boolean
C3166216 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1442989 (UMLS CUI [3,2])
C0042890 (UMLS CUI [3,3])
C3274787 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0025598 (UMLS CUI [4,3])
C1562104 (UMLS CUI [5])
C2917254 (UMLS CUI [6])
C0994475 (UMLS CUI [7,1])
C1283071 (UMLS CUI [7,2])
C0021641 (UMLS CUI [7,3])
C0021641 (UMLS CUI [8])
C1257987 (UMLS CUI [9])
Exclusion Criteria Non-Insulin-Dependent Diabetes Mellitus
Item
exclusion criteria only for subjects with t2d:
boolean
C0680251 (UMLS CUI [1,1])
C0011860 (UMLS CUI [1,2])
Proliferative retinopathy Treatment required for | Disorder of macula of retina Treatment required for | Ophthalmoscopy | Fundus photography
Item
proliferative retinopathy or maculopathy requiring acute treatment as determined by funduscopy/fundus photography and judged by the investigator. if subject presents a medical certificate for funduscopy/fundus photography performed within last 3 months this can substitute the funduscopy/fundus photography at screening
boolean
C0339467 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C0029090 (UMLS CUI [3])
C0200189 (UMLS CUI [4])
Kidney Disease Stage | Renal function GFR estimation by MDRD
Item
nephropathy stages 3 to 5, i.e. estimated glomerular filtration rate (egfr) below 60. the egfrshould be determined using the modification of diet in renal disease 4-variable method encompassing creatinine, age, gender, and race
boolean
C0022658 (UMLS CUI [1,1])
C1306673 (UMLS CUI [1,2])
C2170215 (UMLS CUI [2])
Diabetic peripheral neuropathy | Semmes Weinstein Monofilament Examination Hallux | Semmes Weinstein Monofilament Examination Fifth metatarsal Plantar
Item
diabetic peripheral neuropathy using the 10 g semmes-weinstein monofilament examination at the great toe or plantar aspect of the fifth metatarsal
boolean
C0740447 (UMLS CUI [1])
C4288244 (UMLS CUI [2,1])
C0018534 (UMLS CUI [2,2])
C4288244 (UMLS CUI [3,1])
C0459705 (UMLS CUI [3,2])
C0230463 (UMLS CUI [3,3])
Cardiovascular Disease | Myocardial Infarction | Heart failure New York Heart Association Classification
Item
clinically significant active cardiovascular disease including history of myocardial infarction and/or heart failure (new york heart association (nyha) class iii and iv1) at the discretion of the investigator
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
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