ID

35816

Beskrivning

Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02461589

Länk

https://clinicaltrials.gov/show/NCT02461589

Nyckelord

Versioner (1)
  1. 2019-03-25 2019-03-25 -
Rättsinnehavare

See clincaitrials.gov

Uppladdad den

25 mars 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Eligibility Diabetes NCT02461589

Engelsk

Eligibility Diabetes NCT02461589

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02461589
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age at least 18 years at the time of signing informed consent.
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
Beskrivning

Therapy Stable Diabetes | Diet therapy | Exercise | Metformin Daily Dose | Metformin Maximum Tolerated Dose | Metformin Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0011847
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C2348070
UMLS CUI [5,1]
C0025598
UMLS CUI [5,2]
C0752079
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C0332197
hba1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
bmi: 25.0 - 40.0 kg/m^2 (both inclusive)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
simultaneous participation in any other clinical trial of an investigational medicinal product
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). germany: only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. united kingdom: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Contraceptive injection | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy | Contraceptives, Oral, Hormonal | Hormonal contraception Injectable | Hormonal contraception Implant | Intrauterine System | Contraception, Barrier | Female Condoms | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository | Female Sterilization | Male sterilization

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0332197
UMLS CUI [5]
C1657106
UMLS CUI [6]
C1656586
UMLS CUI [7]
C0009906
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0036899
UMLS CUI [10]
C0420842
UMLS CUI [11]
C0009907
UMLS CUI [12,1]
C2985296
UMLS CUI [12,2]
C0086466
UMLS CUI [13,1]
C2985296
UMLS CUI [13,2]
C0021102
UMLS CUI [14]
C4293370
UMLS CUI [15]
C0004764
UMLS CUI [16]
C0221829
UMLS CUI [17]
C0493327
UMLS CUI [18]
C3843415
UMLS CUI [19]
C0015787
UMLS CUI [20]
C0024559
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
Beskrivning

Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria | Exception Insulin regime short-term Acute illness

Datatyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0376607
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1512693
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0557978
UMLS CUI [4,3]
C0443303
UMLS CUI [4,4]
C4061114
anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Beskrivning

Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | orlistat | Thyroid Hormones | Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005910
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0596620
UMLS CUI [3]
C0076275
UMLS CUI [4]
C0040135
UMLS CUI [5]
C0001617
history of pancreatitis (acute or chronic)
Beskrivning

Pancreatitis | Pancreatitis, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
screening calcitonin above or equal to 50 ng/l
Beskrivning

Calcitonin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201924
family or personal history of multiple endocrine neoplasia type 2 (men2) or medullary thyroid carcinoma (mtc)
Beskrivning

Family history Multiple Endocrine Neoplasia Type | Multiple Endocrine Neoplasia Type | Familial medullary thyroid carcinoma | Medullary carcinoma of thyroid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0027662
UMLS CUI [1,3]
C0332307
UMLS CUI [2,1]
C0027662
UMLS CUI [2,2]
C0332307
UMLS CUI [3]
C1833921
UMLS CUI [4]
C0238462
severe to moderate renal impairment defined as gfr, estimated below 60 ml/min/1.73 m^2 as per ckd-epi (chronic kidney disease epidemiology)
Beskrivning

Renal Insufficiency Severe | Renal Insufficiency Moderate | Estimated Glomerular Filtration Rate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C3811844
within the past 180 days before screening any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
Beskrivning

Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0002965
UMLS CUI [4,1]
C0019993
UMLS CUI [4,2]
C0007787
currently planned coronary, carotid or peripheral artery revascularisation
Beskrivning

Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877341
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C3495793
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C1096418
UMLS CUI [3,2]
C1301732
patients presently classified as being in new york heart association (nyha) class iii or iv
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
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Similar models

Eligibility Diabetes NCT02461589

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02461589
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
male or female, age at least 18 years at the time of signing informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Therapy Stable Diabetes | Diet therapy | Exercise | Metformin Daily Dose | Metformin Maximum Tolerated Dose | Metformin Absent
Item
subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (at least 1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0011847 (UMLS CUI [1,3])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C2348070 (UMLS CUI [4,2])
C0025598 (UMLS CUI [5,1])
C0752079 (UMLS CUI [5,2])
C0025598 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Hemoglobin A1c measurement
Item
hba1c (glycosylated haemoglobin): 53-86 mmol/mol (7.0-10.0%) (both inclusive)
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi: 25.0 - 40.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs
Item
simultaneous participation in any other clinical trial of an investigational medicinal product
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Absent | Contraceptive implant | Contraceptive injection | Combined Oral Contraceptives | Intrauterine Devices | Sexual Abstinence | Partner had vasectomy | Contraceptives, Oral, Hormonal | Hormonal contraception Injectable | Hormonal contraception Implant | Intrauterine System | Contraception, Barrier | Female Condoms | CERVICAL CAP FOR CONTRACEPTIVE USE | Spermicidal foam/jelly/cream/film/suppository | Female Sterilization | Male sterilization
Item
female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). germany: only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. united kingdom: adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C1657106 (UMLS CUI [5])
C1656586 (UMLS CUI [6])
C0009906 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0036899 (UMLS CUI [9])
C0420842 (UMLS CUI [10])
C0009907 (UMLS CUI [11])
C2985296 (UMLS CUI [12,1])
C0086466 (UMLS CUI [12,2])
C2985296 (UMLS CUI [13,1])
C0021102 (UMLS CUI [13,2])
C4293370 (UMLS CUI [14])
C0004764 (UMLS CUI [15])
C0221829 (UMLS CUI [16])
C0493327 (UMLS CUI [17])
C3843415 (UMLS CUI [18])
C0015787 (UMLS CUI [19])
C0024559 (UMLS CUI [20])
Antidiabetics | Anti-Obesity Agents | Exception Inclusion criteria | Exception Insulin regime short-term Acute illness
Item
treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of below or equal to 14 days)
boolean
C0935929 (UMLS CUI [1])
C0376607 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0557978 (UMLS CUI [4,2])
C0443303 (UMLS CUI [4,3])
C4061114 (UMLS CUI [4,4])
Pharmaceutical Preparations Affecting Body Weight | Pharmaceutical Preparations Affecting Glucose metabolism | orlistat | Thyroid Hormones | Adrenal Cortex Hormones
Item
anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005910 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0076275 (UMLS CUI [3])
C0040135 (UMLS CUI [4])
C0001617 (UMLS CUI [5])
Pancreatitis | Pancreatitis, Chronic
Item
history of pancreatitis (acute or chronic)
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Calcitonin measurement
Item
screening calcitonin above or equal to 50 ng/l
boolean
C0201924 (UMLS CUI [1])
Family history Multiple Endocrine Neoplasia Type | Multiple Endocrine Neoplasia Type | Familial medullary thyroid carcinoma | Medullary carcinoma of thyroid
Item
family or personal history of multiple endocrine neoplasia type 2 (men2) or medullary thyroid carcinoma (mtc)
boolean
C0241889 (UMLS CUI [1,1])
C0027662 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0027662 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1833921 (UMLS CUI [3])
C0238462 (UMLS CUI [4])
Renal Insufficiency Severe | Renal Insufficiency Moderate | Estimated Glomerular Filtration Rate
Item
severe to moderate renal impairment defined as gfr, estimated below 60 ml/min/1.73 m^2 as per ckd-epi (chronic kidney disease epidemiology)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3811844 (UMLS CUI [3])
Myocardial Infarction | Cerebrovascular accident | Hospitalization Unstable Angina | Hospitalization Transient Ischemic Attack
Item
within the past 180 days before screening any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0019993 (UMLS CUI [3,1])
C0002965 (UMLS CUI [3,2])
C0019993 (UMLS CUI [4,1])
C0007787 (UMLS CUI [4,2])
Coronary revascularisation Planned | Carotid revascularisation Planned | Peripheral revascularisation Planned
Item
currently planned coronary, carotid or peripheral artery revascularisation
boolean
C0877341 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C3495793 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1096418 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
New York Heart Association Classification
Item
patients presently classified as being in new york heart association (nyha) class iii or iv
boolean
C1275491 (UMLS CUI [1])
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