ID

15075

Beschreibung

A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM12470; ODM derived from: https://clinicaltrials.gov/show/NCT02302443

Link

https://clinicaltrials.gov/show/NCT02302443

Stichworte

Versionen (1)
  1. 14.05.16 14.05.16 -
Hochgeladen am

14. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus NCT02302443

Englisch

Eligibility Diabetes Mellitus NCT02302443

1 Formulare  
Criteria
Beschreibung

Criteria

t2dm more than 12 monthm
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
age ≥18 and ≤70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
body mass index between 18.0 and 35.0 kg/m2 inclusive.
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
Beschreibung

Healthy | Medical History | Physical Examination | Biochemical finding

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0428132
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
Beschreibung

Females | Pregnancy | Breast Feeding | Female Sterilization | Tubal Occlusion | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state | Males | Male sterilization | Sexual Abstinence | Childbearing Potential | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0086287
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0041275
UMLS CUI [6]
C0020699
UMLS CUI [7]
C2243030
UMLS CUI [8]
C0278321
UMLS CUI [9]
C0232970
UMLS CUI [10]
C0086582
UMLS CUI [11]
C0024559
UMLS CUI [12]
C0036899
UMLS CUI [13]
C3831118
UMLS CUI [14]
C0700589
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
Beschreibung

Informed Consent | Research Activities

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0242481
inclusion criteria for t2dm:
Beschreibung

Inclusion | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0011860
t1dm more than 12 monthm
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
age ≥18 and ≤70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
body mass index between 18.0 and 30.0 kg/m2 inclusive.
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
Beschreibung

Healthy | Medical History | Physical Examination | Biochemical finding

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0428132
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
Beschreibung

Females | Pregnancy | Breast Feeding | Female Sterilization | Tubal Occlusion | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state | Males | Male sterilization | Sexual Abstinence | Childbearing Potential | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0086287
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0041275
UMLS CUI [6]
C0020699
UMLS CUI [7]
C2243030
UMLS CUI [8]
C0278321
UMLS CUI [9]
C0232970
UMLS CUI [10]
C0086582
UMLS CUI [11]
C0024559
UMLS CUI [12]
C0036899
UMLS CUI [13]
C3831118
UMLS CUI [14]
C0700589
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
Beschreibung

informed consent | Research Activities

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0242481
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
Beschreibung

Proliferative retinopathy | Disorder of macula of retina Proliferative | Gastroparesis Severe | Neuropathy Severe | Autonomic neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0334094
UMLS CUI [3,1]
C0152020
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0442874
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0259749
recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
Beschreibung

Hypoglycemia Major Recurrent | Hypoglycemia unawareness | Ketoacidosis Recent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C2945760
UMLS CUI [2]
C0342317
UMLS CUI [3,1]
C0220982
UMLS CUI [3,2]
C0332185
pregnant or lactating women
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in an investigational study within 30 days prior to dosing
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
clinically significant abnormal ecg at screening, as judged by the investigator
Beschreibung

Electrocardiogram abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
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Ähnliche Modelle

Eligibility Diabetes Mellitus NCT02302443

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Diabetes Mellitus, Non-Insulin-Dependent
Item
t2dm more than 12 monthm
boolean
C0011860 (UMLS CUI [1])
Age
Item
age ≥18 and ≤70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index between 18.0 and 35.0 kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
Healthy | Medical History | Physical Examination | Biochemical finding
Item
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
boolean
C3898900 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0428132 (UMLS CUI [4])
Females | Pregnancy | Breast Feeding | Female Sterilization | Tubal Occlusion | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state | Males | Male sterilization | Sexual Abstinence | Childbearing Potential | Contraceptive methods
Item
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
boolean
C0086287 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0041275 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C2243030 (UMLS CUI [7])
C0278321 (UMLS CUI [8])
C0232970 (UMLS CUI [9])
C0086582 (UMLS CUI [10])
C0024559 (UMLS CUI [11])
C0036899 (UMLS CUI [12])
C3831118 (UMLS CUI [13])
C0700589 (UMLS CUI [14])
Informed Consent | Research Activities
Item
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
boolean
C0021430 (UMLS CUI [1])
C0242481 (UMLS CUI [2])
Inclusion | Diabetes Mellitus, Non-Insulin-Dependent
Item
inclusion criteria for t2dm:
boolean
C1512693 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Diabetes Mellitus, Insulin-Dependent
Item
t1dm more than 12 monthm
boolean
C0011854 (UMLS CUI [1])
Age
Item
age ≥18 and ≤70 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index between 18.0 and 30.0 kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
Healthy | Medical History | Physical Examination | Biochemical finding
Item
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
boolean
C3898900 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0428132 (UMLS CUI [4])
Females | Pregnancy | Breast Feeding | Female Sterilization | Tubal Occlusion | Hysterectomy | bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state | Males | Male sterilization | Sexual Abstinence | Childbearing Potential | Contraceptive methods
Item
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
boolean
C0086287 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0041275 (UMLS CUI [5])
C0020699 (UMLS CUI [6])
C2243030 (UMLS CUI [7])
C0278321 (UMLS CUI [8])
C0232970 (UMLS CUI [9])
C0086582 (UMLS CUI [10])
C0024559 (UMLS CUI [11])
C0036899 (UMLS CUI [12])
C3831118 (UMLS CUI [13])
C0700589 (UMLS CUI [14])
informed consent | Research Activities
Item
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
boolean
C0021430 (UMLS CUI [1])
C0242481 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Proliferative retinopathy | Disorder of macula of retina Proliferative | Gastroparesis Severe | Neuropathy Severe | Autonomic neuropathy
Item
a subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the investigator
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C0334094 (UMLS CUI [2,2])
C0152020 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0442874 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0259749 (UMLS CUI [5])
Hypoglycemia Major Recurrent | Hypoglycemia unawareness | Ketoacidosis Recent
Item
recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
boolean
C0020615 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,3])
C0342317 (UMLS CUI [2])
C0220982 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in an investigational study within 30 days prior to dosing
boolean
C2348568 (UMLS CUI [1])
Electrocardiogram abnormal
Item
clinically significant abnormal ecg at screening, as judged by the investigator
boolean
C0522055 (UMLS CUI [1])
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