ID

32767

Description

Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00707954

Link

https://clinicaltrials.gov/show/NCT00707954

Keywords

Versions (1)
  1. 11/15/18 11/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00707954

English

Eligibility Type 2 Diabetes Mellitus NCT00707954

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically stable type 2 diabetes mellitus
Description

Non-Insulin-Dependent Diabetes Mellitus Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0205360
females without childbearing potential
Description

Female infertility

Data type

boolean

Alias
UMLS CUI [1]
C0021361
body mass index (bmi) >= 18.5 kg/m2 and <= 39.9 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hemoglobin a1c levels >= 6.5% and <= 10%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
fasting blood glucose levels >= 140 mg/dl and <= 270 mg/dl
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
systolic blood pressure >= 95 mmhg and <= 160 mmhg, and diastolic blood pressure >= 50 mmhg and <= 100 mmhg, and pulse rate >= 50 bpm
Description

Systolic Pressure | Diastolic blood pressure | Pulse Rate

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3]
C0232117
patients who have not been administered anti-diabetic medication within 2 weeks prior to dosing
Description

Antidiabetics Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C0332197
medicines if necessary for hypertension or dyslipidemia should be administered with stable dosage at least 3 months
Description

Antihypertensive Agents Dose Stable | Dyslipidemics Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C4020590
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
treatment with diet and exercise should be unchanged for more than 3 months
Description

Diet therapy unchanged | Exercise unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0012159
UMLS CUI [1,2]
C0442739
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0442739
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus or secondary diabetic mellitus
Description

Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0271640
history of diabetic complications which need treatment
Description

Complications of Diabetes Mellitus Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0332121
treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent
Description

Insulin | Thiazolidinediones | Thiazide Diuretics | Adrenergic beta-1 Receptor Antagonists | Systemic steroids

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C1257987
UMLS CUI [3]
C0012802
UMLS CUI [4]
C0304516
UMLS CUI [5]
C2825233
serum creatinine > upper limit of the normal range
Description

Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0700225
patients with significant complications
Description

Complications Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0750502
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00707954

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Stable
Item
clinically stable type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Female infertility
Item
females without childbearing potential
boolean
C0021361 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) >= 18.5 kg/m2 and <= 39.9 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hemoglobin a1c levels >= 6.5% and <= 10%
boolean
C0474680 (UMLS CUI [1])
Fasting blood glucose measurement
Item
fasting blood glucose levels >= 140 mg/dl and <= 270 mg/dl
boolean
C0428568 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure | Pulse Rate
Item
systolic blood pressure >= 95 mmhg and <= 160 mmhg, and diastolic blood pressure >= 50 mmhg and <= 100 mmhg, and pulse rate >= 50 bpm
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0232117 (UMLS CUI [3])
Antidiabetics Absent
Item
patients who have not been administered anti-diabetic medication within 2 weeks prior to dosing
boolean
C0935929 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Antihypertensive Agents Dose Stable | Dyslipidemics Dose Stable
Item
medicines if necessary for hypertension or dyslipidemia should be administered with stable dosage at least 3 months
boolean
C0003364 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C4020590 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Diet therapy unchanged | Exercise unchanged
Item
treatment with diet and exercise should be unchanged for more than 3 months
boolean
C0012159 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Secondary diabetes mellitus
Item
type 1 diabetes mellitus or secondary diabetic mellitus
boolean
C0011854 (UMLS CUI [1])
C0271640 (UMLS CUI [2])
Complications of Diabetes Mellitus Treatment required for
Item
history of diabetic complications which need treatment
boolean
C0342257 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Insulin | Thiazolidinediones | Thiazide Diuretics | Adrenergic beta-1 Receptor Antagonists | Systemic steroids
Item
treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C0012802 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C2825233 (UMLS CUI [5])
Serum creatinine raised
Item
serum creatinine > upper limit of the normal range
boolean
C0700225 (UMLS CUI [1])
Complications Significant
Item
patients with significant complications
boolean
C0009566 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
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