ID

29132

Descripción

A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00675857

Link

https://clinicaltrials.gov/show/NCT00675857

Palabras clave

Versiones (1)
  1. 27/2/18 27/2/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

27 de febrero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00675857

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00675857

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age and gender eligibility: 30 years and older
Descripción

Age | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
diagnosis of type 2 diabetes mellitus
Descripción

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to the screening visit
Descripción

Metformin Dose Stable | Sulfonylurea Dose Stable | Combined Modality Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0009429
patients must have hba1c level between 7.0-10.0 %, inclusively at screening
Descripción

Glucohemoglobin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202054
the participant must have central obesity (waist circumference) defined per country/ethnic group: europids: men ≥ 94 cm, women ≥ 80 cm; south asian, chinese &
Descripción

Obesity, Abdominal | Waist Circumference | Ethnic group | Caucasoid | Gender | South Asian | Chinese

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0311277
UMLS CUI [2]
C0455829
UMLS CUI [3]
C0015031
UMLS CUI [4]
C0007457
UMLS CUI [5]
C0079399
UMLS CUI [6]
C1519427
UMLS CUI [7]
C0152035
japanese: men ≥ 90 cm, women ≥ 80 cm; and any one of the following metabolic syndrome characteristics at screening:
Descripción

Waist Circumference | Japanese | Gender | Metabolic Syndrome Characteristics Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0455829
UMLS CUI [2]
C1556094
UMLS CUI [3]
C0079399
UMLS CUI [4,1]
C0524620
UMLS CUI [4,2]
C1521970
UMLS CUI [4,3]
C1265611
reduced hdl cholesterol ≤ 1.0 mmol/l
Descripción

Decreased HDL cholesterol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151691
hypertriglyceridemia ≥ 1.7 mmol/l or treatment for dyslipidemia
Descripción

Hypertriglyceridemia | Therapeutic procedure Dyslipidemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020557
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0242339
hypertension: ≥ 130/85 mm hg blood pressure or treatment with antihypertensive medication.
Descripción

Hypertensive disease | Blood pressure determination | Antihypertensive Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005824
UMLS CUI [3]
C0003364
patients must have a glomerular filtration rate (gfr) of ≥ 60 ml/min, and no history of dialysis.
Descripción

Glomerular Filtration Rate | Dialysis Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017654
UMLS CUI [2,1]
C0011946
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients having received insulin, thiazolidinediones (tzds) or non-thiazolidinedione hypoglycemic agents other than metformin or sulfonylurea agents within three months prior to screening
Descripción

Insulin | Thiazolidinediones | Hypoglycemic Agents | Exception Metformin | Exception Sulfonylurea

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C1257987
UMLS CUI [3]
C0020616
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0025598
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0038766
has had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (ptca), congestive heart failure (new york heart association class iii-iv), or severe ischemic disease
Descripción

Heart Disease | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Congestive heart failure New York Heart Association Classification | Myocardial Ischemia Severe

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0010055
UMLS CUI [6]
C2936173
UMLS CUI [7,1]
C0018802
UMLS CUI [7,2]
C1275491
UMLS CUI [8,1]
C0151744
UMLS CUI [8,2]
C0205082
patients who have an increased red blood cell (rbc) turn-over or thalassemia or anemia
Descripción

Red blood cell count raised | Thalassemia | Anemia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0427458
UMLS CUI [2]
C0039730
UMLS CUI [3]
C0002871
known hiv or history of viral hepatitis type b or c.
Descripción

HIV Infection | Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
any type of diabetes other than type 2 diabetes
Descripción

Diabetes type Any | Exception Non-Insulin-Dependent Diabetes Mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1320657
UMLS CUI [1,2]
C1552551
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0011860
significant hepatic enzyme elevation
Descripción

Elevated liver enzymes

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0235996
body mass index (bmi) of > 40kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
current or previous use of oral or injectable corticosteroids, or conditions that require the use of corticosteroids, during the three months prior to screening
Descripción

Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable | Condition Requirement Adrenal Cortex Hormones

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0086466
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0001617
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00675857

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Gender
Item
age and gender eligibility: 30 years and older
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes mellitus
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable | Sulfonylurea Dose Stable | Combined Modality Therapy
Item
patients treated with a stable therapeutic dose of either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent for a minimum period of 3 months prior to the screening visit
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3])
Glucohemoglobin measurement
Item
patients must have hba1c level between 7.0-10.0 %, inclusively at screening
boolean
C0202054 (UMLS CUI [1])
Obesity, Abdominal | Waist Circumference | Ethnic group | Caucasoid | Gender | South Asian | Chinese
Item
the participant must have central obesity (waist circumference) defined per country/ethnic group: europids: men ≥ 94 cm, women ≥ 80 cm; south asian, chinese &
boolean
C0311277 (UMLS CUI [1])
C0455829 (UMLS CUI [2])
C0015031 (UMLS CUI [3])
C0007457 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C1519427 (UMLS CUI [6])
C0152035 (UMLS CUI [7])
Waist Circumference | Japanese | Gender | Metabolic Syndrome Characteristics Quantity
Item
japanese: men ≥ 90 cm, women ≥ 80 cm; and any one of the following metabolic syndrome characteristics at screening:
boolean
C0455829 (UMLS CUI [1])
C1556094 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0524620 (UMLS CUI [4,1])
C1521970 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Decreased HDL cholesterol
Item
reduced hdl cholesterol ≤ 1.0 mmol/l
boolean
C0151691 (UMLS CUI [1])
Hypertriglyceridemia | Therapeutic procedure Dyslipidemia
Item
hypertriglyceridemia ≥ 1.7 mmol/l or treatment for dyslipidemia
boolean
C0020557 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
Hypertensive disease | Blood pressure determination | Antihypertensive Agents
Item
hypertension: ≥ 130/85 mm hg blood pressure or treatment with antihypertensive medication.
boolean
C0020538 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
C0003364 (UMLS CUI [3])
Glomerular Filtration Rate | Dialysis Absent
Item
patients must have a glomerular filtration rate (gfr) of ≥ 60 ml/min, and no history of dialysis.
boolean
C0017654 (UMLS CUI [1])
C0011946 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Insulin | Thiazolidinediones | Hypoglycemic Agents | Exception Metformin | Exception Sulfonylurea
Item
patients having received insulin, thiazolidinediones (tzds) or non-thiazolidinedione hypoglycemic agents other than metformin or sulfonylurea agents within three months prior to screening
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C0020616 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
Heart Disease | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Congestive heart failure New York Heart Association Classification | Myocardial Ischemia Severe
Item
has had, within the last 6 months, evidence of significant heart disease or stroke, including myocardial infarction, unstable angina, coronary bypass and/or percutaneous transluminal coronary angioplasty (ptca), congestive heart failure (new york heart association class iii-iv), or severe ischemic disease
boolean
C0018799 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C2936173 (UMLS CUI [6])
C0018802 (UMLS CUI [7,1])
C1275491 (UMLS CUI [7,2])
C0151744 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
Red blood cell count raised | Thalassemia | Anemia
Item
patients who have an increased red blood cell (rbc) turn-over or thalassemia or anemia
boolean
C0427458 (UMLS CUI [1])
C0039730 (UMLS CUI [2])
C0002871 (UMLS CUI [3])
HIV Infection | Hepatitis B | Hepatitis C
Item
known hiv or history of viral hepatitis type b or c.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Diabetes type Any | Exception Non-Insulin-Dependent Diabetes Mellitus
Item
any type of diabetes other than type 2 diabetes
boolean
C1320657 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0011860 (UMLS CUI [2,2])
Elevated liver enzymes
Item
significant hepatic enzyme elevation
boolean
C0235996 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of > 40kg/m2
boolean
C1305855 (UMLS CUI [1])
Adrenal Cortex Hormones Oral | Adrenal Cortex Hormones Injectable | Condition Requirement Adrenal Cortex Hormones
Item
current or previous use of oral or injectable corticosteroids, or conditions that require the use of corticosteroids, during the three months prior to screening
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0086466 (UMLS CUI [2,2])
C0348080 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0001617 (UMLS CUI [3,3])
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