ID

38746

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01516476

Nyckelord

  1. 2019-10-31 2019-10-31 -
  2. 2019-10-31 2019-10-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 oktober 2019

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Diabetes Mellitus, Type 2 NCT01516476

Eligibility Diabetes Mellitus, Type 2 NCT01516476

Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Adult | Age

Datatyp

boolean

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

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

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

Metformin Dose Stable

Datatyp

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
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

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

Plasma fasting glucose measurement

Datatyp

boolean

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

Body mass index

Datatyp

boolean

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

Maintenance Dietary Habits | Maintenance Exercise Habits

Datatyp

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
Beskrivning

C-peptide measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202100
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Liver disease | Kidney Disease

Datatyp

boolean

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

Uncontrolled hypertension

Datatyp

boolean

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

Cardiovascular Disease

Datatyp

boolean

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

Complications of Diabetes Mellitus

Datatyp

boolean

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

Gastrointestinal condition Significant

Datatyp

boolean

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

Bariatric Surgery | Procedures Involving Gastrointestinal tract

Datatyp

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
Beskrivning

Pancreatitis, Chronic | Pancreatitis

Datatyp

boolean

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

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01516476

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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