ID

16076

Description

A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM); ODM derived from: https://clinicaltrials.gov/show/NCT02367066

Link

https://clinicaltrials.gov/show/NCT02367066

Keywords

Versions (1)
  1. 6/28/16 6/28/16 -
Uploaded on

June 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02367066

English

Eligibility Type 2 Diabetes Mellitus NCT02367066

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provision of informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
Description

Gender | Childbearing Potential | Postmenopausal state | Hysterectomy | Bilateral oophorectomy | Salpingectomy | Tubal Ligation | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0020699
UMLS CUI [5]
C0278321
UMLS CUI [6]
C0041271
UMLS CUI [7]
C0520483
UMLS CUI [8]
C0001779
patients with hba1c ≥7.5 but ≤11% at enrolment visit (visit 1)
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
ody mass index >19 to <38 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
he fasting plasma glucose should be in the range of 3-14 mmol/l (54-252 mg/dl, nclusive) on the morning of visit 1.
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
clinical diagnosis of type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
metformin as only anti-diabetic treatment, at least for the last 3 months
Description

Diabetes Therapy Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C3274787
UMLS CUI [1,2]
C0025598
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
Description

Disease Significant At risk Study Subject Participation Status | Disease Significant Affecting research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0683954
any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
Description

Clinical Chemistry Tests Abnormality Significant | Hematology procedure Abnormality Significant | Urinalysis Abnormality Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0525044
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0750502
UMLS CUI [2,1]
C0200627
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0750502
UMLS CUI [3,1]
C0042014
UMLS CUI [3,2]
C1704258
UMLS CUI [3,3]
C0750502
aspartate aminotransferase (ast) or alanine aminotransferase (alt) laboratory results >3x upper level of normal range (uln) clinical diagnosis of type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive glutamic acid decarboxylase autoantibodies test (gad antibodies test).
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis | serum glutamic acid decarboxylase (GAD) antibody test Positive

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0011854
UMLS CUI [4]
C0011880
UMLS CUI [5,1]
C2208796
UMLS CUI [5,2]
C1446409
patients treated with single insulin therapy within the last 3 months
Description

Insulin regime Single

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205171
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02367066

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
provision of informed consent
boolean
C0021430 (UMLS CUI [1])
Gender | Childbearing Potential | Postmenopausal state | Hysterectomy | Bilateral oophorectomy | Salpingectomy | Tubal Ligation | Age
Item
male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18.
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0278321 (UMLS CUI [5])
C0041271 (UMLS CUI [6])
C0520483 (UMLS CUI [7])
C0001779 (UMLS CUI [8])
Glycosylated hemoglobin A
Item
patients with hba1c ≥7.5 but ≤11% at enrolment visit (visit 1)
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
ody mass index >19 to <38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
he fasting plasma glucose should be in the range of 3-14 mmol/l (54-252 mg/dl, nclusive) on the morning of visit 1.
boolean
C0583513 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Diabetes Therapy Metformin
Item
metformin as only anti-diabetic treatment, at least for the last 3 months
boolean
C3274787 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease Significant At risk Study Subject Participation Status | Disease Significant Affecting research results
Item
history or sign of any clinically significant disease or disorder which, in the opinion f the investigator, may either put the subject at risk because of participation in the sudy, or influence the results or the subject's ability to participate in the study
boolean
C0012634 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Clinical Chemistry Tests Abnormality Significant | Hematology procedure Abnormality Significant | Urinalysis Abnormality Significant
Item
any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
boolean
C0525044 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0200627 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0042014 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Diabetes Mellitus, Insulin-Dependent | Diabetic Ketoacidosis | serum glutamic acid decarboxylase (GAD) antibody test Positive
Item
aspartate aminotransferase (ast) or alanine aminotransferase (alt) laboratory results >3x upper level of normal range (uln) clinical diagnosis of type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive glutamic acid decarboxylase autoantibodies test (gad antibodies test).
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0011880 (UMLS CUI [4])
C2208796 (UMLS CUI [5,1])
C1446409 (UMLS CUI [5,2])
Insulin regime Single
Item
patients treated with single insulin therapy within the last 3 months
boolean
C0557978 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
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