ID

29156

Description

A Study for Patients With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00804986

Link

https://clinicaltrials.gov/show/NCT00804986

Keywords

Versions (1)
  1. 3/2/18 3/2/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 2, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00804986

English

Eligibility Diabetes Mellitus, Type 2 NCT00804986

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
Description

Diet therapy | Exercise | Combined Modality Therapy | Metformin U/day

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3]
C0009429
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0456683
have a glycosylated fraction of hemoglobin a (hba1c) value of 7.0% - 10.0% at screening
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
Description

Childbearing Potential Pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1265611
have a body mass index (bmi) between 25 and 40 kilograms per square meters kg/m^2) at screening
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
stable weight during the 3 months prior to screening.
Description

Stable body weight Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0517386
UMLS CUI [1,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use any antidiabetic agent other than metformin during the 2 months prior to screening.
Description

Antidiabetics | Exception Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
Description

Gastrointestinal Disease Impact Gastric Emptying | Gastrointestinal Disease Impact Gastric motility | Bariatric Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0017127
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0232572
UMLS CUI [3]
C1456587
are currently taking prescription or over-the counter medications to promote weight loss.
Description

Weight-Loss Agents | Non-Prescription Drugs Weight loss

Data type

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C1262477
have been previously diagnosed with pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
women who are breastfeeding.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
have a history of myocardial infarction, unstable angina, coronary artery bypass graft (cabg), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
Description

Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Transient Ischemic Attack | Cerebrovascular accident | CONGESTIVE HEART FAILURE DECOMPENSATED

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0010055
UMLS CUI [4]
C1532338
UMLS CUI [5]
C0007787
UMLS CUI [6]
C0038454
UMLS CUI [7]
C0742746
have poorly controlled hypertension
Description

Poor hypertension control

Data type

boolean

Alias
UMLS CUI [1]
C0421190
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00804986

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
boolean
C0011860 (UMLS CUI [1])
Diet therapy | Exercise | Combined Modality Therapy | Metformin U/day
Item
treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
Glucohemoglobin measurement
Item
have a glycosylated fraction of hemoglobin a (hba1c) value of 7.0% - 10.0% at screening
boolean
C0202054 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Sexual Abstinence | Childbearing Potential Contraceptive methods Quantity
Item
women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Body mass index
Item
have a body mass index (bmi) between 25 and 40 kilograms per square meters kg/m^2) at screening
boolean
C1305855 (UMLS CUI [1])
Stable body weight Duration
Item
stable weight during the 3 months prior to screening.
boolean
C0517386 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Antidiabetics | Exception Metformin
Item
use any antidiabetic agent other than metformin during the 2 months prior to screening.
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
Gastrointestinal Disease Impact Gastric Emptying | Gastrointestinal Disease Impact Gastric motility | Bariatric Surgery
Item
have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
boolean
C0017178 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0017127 (UMLS CUI [1,3])
C0017178 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0232572 (UMLS CUI [2,3])
C1456587 (UMLS CUI [3])
Weight-Loss Agents | Non-Prescription Drugs Weight loss
Item
are currently taking prescription or over-the counter medications to promote weight loss.
boolean
C0376606 (UMLS CUI [1])
C0013231 (UMLS CUI [2,1])
C1262477 (UMLS CUI [2,2])
Pancreatitis
Item
have been previously diagnosed with pancreatitis
boolean
C0030305 (UMLS CUI [1])
Breast Feeding
Item
women who are breastfeeding.
boolean
C0006147 (UMLS CUI [1])
Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Transient Ischemic Attack | Cerebrovascular accident | CONGESTIVE HEART FAILURE DECOMPENSATED
Item
have a history of myocardial infarction, unstable angina, coronary artery bypass graft (cabg), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
C0038454 (UMLS CUI [6])
C0742746 (UMLS CUI [7])
Poor hypertension control
Item
have poorly controlled hypertension
boolean
C0421190 (UMLS CUI [1])
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