ID

37332

Description

The Efficacy of Glucerna SR in Chinese Drug-naïve Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02248714

Link

https://clinicaltrials.gov/show/NCT02248714

Keywords

Versions (1)
  1. 7/17/19 7/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02248714

English

Eligibility Type 2 Diabetes Mellitus NCT02248714

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed type 2 diabetes mellitus
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
fpg≤13mmol/l and/or 2hpg≤18mmol/l
Description

Plasma fasting glucose measurement | 2-hour postprandial plasma glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C2317810
hba1c≥7.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
bmi (body mass index)≥18.5kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients taking any class of injectible or oral hypoglycemia agents to manage their hyperglycemia.
Description

Hypoglycemic Agents Injectable Hyperglycemia | Hypoglycemic Agents Oral Hyperglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C1828121
UMLS CUI [1,3]
C0020456
UMLS CUI [2,1]
C0020616
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0020456
female patients are in gestation, lactation or intend to be pregnant in the study period.
Description

Pregnancy | Breast Feeding | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
patients are with type 1 diabetes, or other special types of diabetes, or gestational diabetes mellitus.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes type Special | Gestational Diabetes

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C1320657
UMLS CUI [2,2]
C0205555
UMLS CUI [3]
C0085207
patients with drug hypersensitivity.
Description

Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0013182
patients with obvious hepatic or renal diseases (alt, t-bil>1.5 times of upper limit)
Description

Liver diseases | Kidney Diseases | Alanine aminotransferase increased | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0741494
patients with severe or unstable angina, or heart failure (nyha class iii/iv)
Description

Angina Pectoris Severe | Angina, Unstable | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0002965
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
patients having acute complications, or chronic complications maintained insulin therapy or insulin therapy under stress.
Description

Complications | Insulin regime Complications chronic | Insulin regime During Stress

Data type

boolean

Alias
UMLS CUI [1]
C0009566
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0009566
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C0038435
patients with chronic consumptive diseases like cerebrovascular disease, tumor, tuberculosis, or hematopathy, psychosis, autoimmune disease or severe digestive dysfunction.
Description

Phthisis chronic | Cerebrovascular Disorder | Tumor | Tuberculosis | Hematological Disease | Psychotic Disorder | Autoimmune Disease | Gastrointestinal dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0041327
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0007820
UMLS CUI [3]
C0027651
UMLS CUI [4]
C0041296
UMLS CUI [5]
C0018939
UMLS CUI [6]
C0033975
UMLS CUI [7]
C0004364
UMLS CUI [8,1]
C0679407
UMLS CUI [8,2]
C0205082
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02248714

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
newly diagnosed type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Plasma fasting glucose measurement | 2-hour postprandial plasma glucose measurement
Item
fpg≤13mmol/l and/or 2hpg≤18mmol/l
boolean
C0583513 (UMLS CUI [1])
C2317810 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
hba1c≥7.0%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
bmi (body mass index)≥18.5kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypoglycemic Agents Injectable Hyperglycemia | Hypoglycemic Agents Oral Hyperglycemia
Item
patients taking any class of injectible or oral hypoglycemia agents to manage their hyperglycemia.
boolean
C0020616 (UMLS CUI [1,1])
C1828121 (UMLS CUI [1,2])
C0020456 (UMLS CUI [1,3])
C0020616 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0020456 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
female patients are in gestation, lactation or intend to be pregnant in the study period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Diabetes type Special | Gestational Diabetes
Item
patients are with type 1 diabetes, or other special types of diabetes, or gestational diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
C1320657 (UMLS CUI [2,1])
C0205555 (UMLS CUI [2,2])
C0085207 (UMLS CUI [3])
Drug Allergy
Item
patients with drug hypersensitivity.
boolean
C0013182 (UMLS CUI [1])
Liver diseases | Kidney Diseases | Alanine aminotransferase increased | Elevated total bilirubin
Item
patients with obvious hepatic or renal diseases (alt, t-bil>1.5 times of upper limit)
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Angina Pectoris Severe | Angina, Unstable | Heart failure New York Heart Association Classification
Item
patients with severe or unstable angina, or heart failure (nyha class iii/iv)
boolean
C0002962 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
Complications | Insulin regime Complications chronic | Insulin regime During Stress
Item
patients having acute complications, or chronic complications maintained insulin therapy or insulin therapy under stress.
boolean
C0009566 (UMLS CUI [1])
C0557978 (UMLS CUI [2,1])
C0009566 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0557978 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C0038435 (UMLS CUI [3,3])
Phthisis chronic | Cerebrovascular Disorder | Tumor | Tuberculosis | Hematological Disease | Psychotic Disorder | Autoimmune Disease | Gastrointestinal dysfunction Severe
Item
patients with chronic consumptive diseases like cerebrovascular disease, tumor, tuberculosis, or hematopathy, psychosis, autoimmune disease or severe digestive dysfunction.
boolean
C0041327 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0007820 (UMLS CUI [2])
C0027651 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
C0018939 (UMLS CUI [5])
C0033975 (UMLS CUI [6])
C0004364 (UMLS CUI [7])
C0679407 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
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