ID

37347

Beschrijving

TAK-648 in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02430870

Link

https://clinicaltrials.gov/show/NCT02430870

Trefwoorden

Versies (1)
  1. 19-07-19 19-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02430870

Engels

Eligibility Type 2 Diabetes Mellitus NCT02430870

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
part 1:
Beschrijving

Part Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0237753
has a historical diagnosis of t2dm disease, on diet and exercise or on metformin
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4]
C0025598
weighs at least 55 kg and has a body mass index (bmi) from 25.0 to 30.0 kg/m^2, inclusive at screening
Beschrijving

Body Weight | Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
has a systolic blood pressure >90 and ≤150 mm hg and a diastolic blood pressure of >60 and ≤90 mm hg at screening and at check-in (day -2)
Beschrijving

Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
has a calculated creatinine clearance >60 ml/min at screening and check-in (day -2)
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
hemoglobin a1c (hba1c) level between 7.0% and 10.0%, inclusive
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
part 2:
Beschrijving

Part Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0237753
health participants of japanese origin
Beschrijving

Healthy Volunteers Japanese

Datatype

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C1556094
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
part 1 and part 2:
Beschrijving

Part Number

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449719
UMLS CUI [1,2]
C0237753
has received any investigational compound within 30 days prior to the first dose of study medication
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
history of significant gastrointestinal (gi) disorders part 1, has diagnosis of major depression and risk of suicide, part 1, is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period
Beschrijving

Gastrointestinal Diseases | Major Depressive Disorder | At risk for suicide | Pregnancy | Breast Feeding | Pregnancy, Planned | Ovum Donation intended

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C1269683
UMLS CUI [3]
C0563664
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0006147
UMLS CUI [6]
C0032992
UMLS CUI [7,1]
C0242812
UMLS CUI [7,2]
C1283828
intends to donate sperm during the course of this study or for 12 weeks thereafter
Beschrijving

Sperm donation intended

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871414
UMLS CUI [1,2]
C1283828
has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to day 1
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma Remission Duration

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C0687702
UMLS CUI [2,4]
C0449238
has a positive test result for hepatitis b surface antigen (hbsag), antibody to hepatitis c virus (anti-hcv), at screening or a known history of human immunodeficiency virus infection
Beschrijving

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019693
has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to check-in (day -2). cotinine test is positive at screening or check-in (day -2)
Beschrijving

Nicotine product | Cigarette | Pipe | Cigars | Oral Tobacco | Nicotine Patch | Nicotine Gum | Urine cotinine test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0028040
UMLS CUI [2]
C0677453
UMLS CUI [3]
C0678447
UMLS CUI [4]
C0678446
UMLS CUI [5]
C0008038
UMLS CUI [6]
C0358855
UMLS CUI [7]
C0599654
UMLS CUI [8]
C1699505
history of t1dm, hypoglycemia unawareness, diabetic ketoacidosis, or hyperosmolar coma
Beschrijving

Diabetes Mellitus, Insulin-Dependent | Loss of hypoglycemic warning | Diabetic Ketoacidosis | Hyperosmolar Coma

Datatype

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0342317
UMLS CUI [3]
C0011880
UMLS CUI [4]
C0020457
has received any antihyperglycemic medication with the exception of metformin within the previous 12 weeks of check-in (day -2)
Beschrijving

Hypoglycemic Agents | Exception Metformin

Datatype

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02430870

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Part Number
Item
part 1:
boolean
C0449719 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Metformin
Item
has a historical diagnosis of t2dm disease, on diet and exercise or on metformin
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0025598 (UMLS CUI [4])
Body Weight | Body mass index
Item
weighs at least 55 kg and has a body mass index (bmi) from 25.0 to 30.0 kg/m^2, inclusive at screening
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Systolic Pressure | Diastolic blood pressure
Item
has a systolic blood pressure >90 and ≤150 mm hg and a diastolic blood pressure of >60 and ≤90 mm hg at screening and at check-in (day -2)
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
has a calculated creatinine clearance >60 ml/min at screening and check-in (day -2)
boolean
C2711451 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hemoglobin a1c (hba1c) level between 7.0% and 10.0%, inclusive
boolean
C0474680 (UMLS CUI [1])
Part Number
Item
part 2:
boolean
C0449719 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Healthy Volunteers Japanese
Item
health participants of japanese origin
boolean
C1708335 (UMLS CUI [1,1])
C1556094 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Part Number
Item
part 1 and part 2:
boolean
C0449719 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigational New Drugs
Item
has received any investigational compound within 30 days prior to the first dose of study medication
boolean
C0013230 (UMLS CUI [1])
Gastrointestinal Diseases | Major Depressive Disorder | At risk for suicide | Pregnancy | Breast Feeding | Pregnancy, Planned | Ovum Donation intended
Item
history of significant gastrointestinal (gi) disorders part 1, has diagnosis of major depression and risk of suicide, part 1, is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period
boolean
C0017178 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0563664 (UMLS CUI [3])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
C0032992 (UMLS CUI [6])
C0242812 (UMLS CUI [7,1])
C1283828 (UMLS CUI [7,2])
Sperm donation intended
Item
intends to donate sperm during the course of this study or for 12 weeks thereafter
boolean
C0871414 (UMLS CUI [1,1])
C1283828 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Basal cell carcinoma Remission Duration
Item
has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to day 1
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C0687702 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Infection
Item
has a positive test result for hepatitis b surface antigen (hbsag), antibody to hepatitis c virus (anti-hcv), at screening or a known history of human immunodeficiency virus infection
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Nicotine product | Cigarette | Pipe | Cigars | Oral Tobacco | Nicotine Patch | Nicotine Gum | Urine cotinine test positive
Item
has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to check-in (day -2). cotinine test is positive at screening or check-in (day -2)
boolean
C0028040 (UMLS CUI [1])
C0677453 (UMLS CUI [2])
C0678447 (UMLS CUI [3])
C0678446 (UMLS CUI [4])
C0008038 (UMLS CUI [5])
C0358855 (UMLS CUI [6])
C0599654 (UMLS CUI [7])
C1699505 (UMLS CUI [8])
Diabetes Mellitus, Insulin-Dependent | Loss of hypoglycemic warning | Diabetic Ketoacidosis | Hyperosmolar Coma
Item
history of t1dm, hypoglycemia unawareness, diabetic ketoacidosis, or hyperosmolar coma
boolean
C0011854 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
C0011880 (UMLS CUI [3])
C0020457 (UMLS CUI [4])
Hypoglycemic Agents | Exception Metformin
Item
has received any antihyperglycemic medication with the exception of metformin within the previous 12 weeks of check-in (day -2)
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
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