ID

23425

Description

Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone; ODM derived from: https://clinicaltrials.gov/show/NCT00402909

Link

https://clinicaltrials.gov/show/NCT00402909

Keywords

Versions (1)
  1. 7/4/17 7/4/17 -
Uploaded on

July 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00402909

English

Eligibility Type 2 Diabetes NCT00402909

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male/female, age 18-78 inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
Description

Diabetes Mellitus, Non-Insulin-Dependent | Glargine Dose Stable | Metformin Dose Stable | Thiazolidinediones Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0907402
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1257987
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
hba1c 7.0-8.5% inclusive
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
fasting plasma glucose <240 mg/dl at screening
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
body mass index 22-41 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other investigational drugs within 30 days of screening
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
Description

Antidiabetics | Metformin | Glargine | Thiazolidinediones

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0907402
UMLS CUI [4]
C1257987
history of type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
abnormal kidney function
Description

Abnormal renal function

Data type

boolean

Alias
UMLS CUI [1]
C0151746
history of acute diabetic complications
Description

Complications of Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0342257
congestive heart failure requiring treatment
Description

Congestive heart failure Treatment required for

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0332121
myocardial infarction, coronary artery surgery, stroke within 6 months of screening
Description

Myocardial Infarction | Coronary Artery Bypass Surgery | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0038454
liver disease, liver enzymes more than 3 times upper limit of normal
Description

Liver diseases | Elevated liver enzymes

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0235996
fasting triglycerides >700 mg/dl within past 12 weeks
Description

Serum fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0582824
acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data
Description

Communicable Diseases Affecting Blood Glucose | Communicable Diseases Interfere with Interpretation research data | Condition Affecting Blood Glucose | Condition Interferes with Interpretation research data

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005802
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0681873
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0005802
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0459471
UMLS CUI [4,4]
C0681873
treatment with corticosteroids
Description

Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
blood donation within past 12 weeks
Description

Blood Donation

Data type

boolean

Alias
UMLS CUI [1]
C0005794
other protocol-defined inclusion/exclusion criterial may apply.
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Type 2 Diabetes NCT00402909

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male/female, age 18-78 inclusive
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Glargine Dose Stable | Metformin Dose Stable | Thiazolidinediones Dose Stable
Item
type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
boolean
C0011860 (UMLS CUI [1])
C0907402 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1257987 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Glycosylated hemoglobin A
Item
hba1c 7.0-8.5% inclusive
boolean
C0019018 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose <240 mg/dl at screening
boolean
C0583513 (UMLS CUI [1])
Body mass index
Item
body mass index 22-41 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
other investigational drugs within 30 days of screening
boolean
C0013230 (UMLS CUI [1])
Antidiabetics | Metformin | Glargine | Thiazolidinediones
Item
treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
boolean
C0935929 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0907402 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Abnormal renal function
Item
abnormal kidney function
boolean
C0151746 (UMLS CUI [1])
Complications of Diabetes Mellitus
Item
history of acute diabetic complications
boolean
C0342257 (UMLS CUI [1])
Congestive heart failure Treatment required for
Item
congestive heart failure requiring treatment
boolean
C0018802 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Myocardial Infarction | Coronary Artery Bypass Surgery | Cerebrovascular accident
Item
myocardial infarction, coronary artery surgery, stroke within 6 months of screening
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
Liver diseases | Elevated liver enzymes
Item
liver disease, liver enzymes more than 3 times upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
Serum fasting triglyceride measurement
Item
fasting triglycerides >700 mg/dl within past 12 weeks
boolean
C0582824 (UMLS CUI [1])
Communicable Diseases Affecting Blood Glucose | Communicable Diseases Interfere with Interpretation research data | Condition Affecting Blood Glucose | Condition Interferes with Interpretation research data
Item
acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data
boolean
C0009450 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005802 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0681873 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005802 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0459471 (UMLS CUI [4,3])
C0681873 (UMLS CUI [4,4])
Adrenal Cortex Hormones
Item
treatment with corticosteroids
boolean
C0001617 (UMLS CUI [1])
Blood Donation
Item
blood donation within past 12 weeks
boolean
C0005794 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criterial may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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