ID

38746

Description

Study of RO6807952 in Patients With Diabetes Mellitus Type 2; ODM derived from: https://clinicaltrials.gov/show/NCT01516476

Link

https://clinicaltrials.gov/show/NCT01516476

Keywords

Versions (2)
  1. 10/31/19 10/31/19 -
  2. 10/31/19 10/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01516476

English

Eligibility Diabetes Mellitus, Type 2 NCT01516476

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients >/= 18 and </=70 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
diagnosis of diabetes mellitus, type 2 for at least 3 months
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
treated with a stable dose of metformin
Description

Metformin Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
hemoglobin a1c >/=7.0% and </=10.5% at screening
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
fasting plasma glucose </=240 mg/dl at screening
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
body mass index >/=27 kg/m2 and </=42 kg/m2 at screening
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
willing and able to maintain existing diet and exercise habits throughout the study
Description

Maintenance Dietary Habits | Maintenance Exercise Habits

Data type

boolean

Alias
UMLS CUI [1,1]
C0024501
UMLS CUI [1,2]
C0086152
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0015259
UMLS CUI [2,3]
C0018464
c-peptide >1.5 ng/ml at screening
Description

C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of significant liver or kidney disease
Description

Liver disease | Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
history of uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
history of significant cardiovascular disease
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
history of significant diabetic complications
Description

Complications of Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0342257
history of significant gastrointestinal conditions
Description

Gastrointestinal condition Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C4062441
UMLS CUI [1,2]
C0750502
history of weight loss surgery or procedures involving the gastrointestinal tract
Description

Bariatric Surgery | Procedures Involving Gastrointestinal tract

Data type

boolean

Alias
UMLS CUI [1]
C1456587
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0017189
history of chronic or acute pancreatitis
Description

Pancreatitis, Chronic | Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0030305
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01516476

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients >/= 18 and </=70 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of diabetes mellitus, type 2 for at least 3 months
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metformin Dose Stable
Item
treated with a stable dose of metformin
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hemoglobin a1c >/=7.0% and </=10.5% at screening
boolean
C0474680 (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 >/=27 kg/m2 and </=42 kg/m2 at screening
boolean
C1305855 (UMLS CUI [1])
Maintenance Dietary Habits | Maintenance Exercise Habits
Item
willing and able to maintain existing diet and exercise habits throughout the study
boolean
C0024501 (UMLS CUI [1,1])
C0086152 (UMLS CUI [1,2])
C0024501 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0018464 (UMLS CUI [2,3])
C-peptide measurement
Item
c-peptide >1.5 ng/ml at screening
boolean
C0202100 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver disease | Kidney Disease
Item
history of significant liver or kidney disease
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Uncontrolled hypertension
Item
history of uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Cardiovascular Disease
Item
history of significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Complications of Diabetes Mellitus
Item
history of significant diabetic complications
boolean
C0342257 (UMLS CUI [1])
Gastrointestinal condition Significant
Item
history of significant gastrointestinal conditions
boolean
C4062441 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Bariatric Surgery | Procedures Involving Gastrointestinal tract
Item
history of weight loss surgery or procedures involving the gastrointestinal tract
boolean
C1456587 (UMLS CUI [1])
C0184661 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0017189 (UMLS CUI [2,3])
Pancreatitis, Chronic | Pancreatitis
Item
history of chronic or acute pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0030305 (UMLS CUI [2])
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