ID

32749

Description

Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4); ODM derived from: https://clinicaltrials.gov/show/NCT00676338

Link

https://clinicaltrials.gov/show/NCT00676338

Keywords

Versions (1)
  1. 11/14/18 11/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00676338

English

Eligibility Type 2 Diabetes Mellitus NCT00676338

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes and are treated with diet and exercise alone.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
at least 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hba1c between 7.1% and 11.0%, inclusive.
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) of 23 kg/m2 to 45 kg/m2, inclusive.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
Description

Stable body weight | Variability Percentage Timespan

Data type

boolean

Alias
UMLS CUI [1]
C0517386
UMLS CUI [2,1]
C2827666
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0872291
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
ave history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
Description

Heart Disease | Myocardial Infarction | Cardiac Arrhythmia | Angina, Unstable | Congestive heart failure Moderate | Congestive heart failure Severe | Coronary Artery Bypass Surgery | Angioplasty

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0205081
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C0205082
UMLS CUI [7]
C0010055
UMLS CUI [8]
C0162577
have a history of renal transplantation or are currently receiving renal dialysis
Description

Kidney Transplantation | Dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Description

Malignant Neoplasms | Malignant Neoplasm Untreated | Cancer Remission | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of prostate

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0687702
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0154088
have history of severe gi disorder (e.g., gastroparesis)
Description

Gastrointestinal Disease Severe | Gastroparesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0152020
have a history of acute or chronic pancreatitis.
Description

Pancreatitis | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2]
C0149521
have active proliferative retinopathy.
Description

Proliferative retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0339467
have been treated with drugs that promote weight loss (e.g., xenical®[orlistat], meridia® [sibutramine], acomplia® [rimonabant], acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
Description

Weight-Loss Agents | Xenical | orlistat | Meridia | sibutramine | Acomplia | rimonabant | Phenylpropanolamine

Data type

boolean

Alias
UMLS CUI [1]
C0376606
UMLS CUI [2]
C0732649
UMLS CUI [3]
C0076275
UMLS CUI [4]
C0635898
UMLS CUI [5]
C0074493
UMLS CUI [6]
C2002731
UMLS CUI [7]
C1142933
UMLS CUI [8]
C0031495
have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
Description

Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C0935929
have had an organ transplant.
Description

Organ Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0029216
have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
Description

Study Subject Participation Status | Investigational New Drug Completed | Investigational New Drug Discontinued | Patient withdrawn from trial | exenatide

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1444662
UMLS CUI [4]
C0422727
UMLS CUI [5]
C0167117
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Description

Pharmaceutical Preparation Approval Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205540
UMLS CUI [1,3]
C0332268
are currently enrolled in any other clinical study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00676338

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise
Item
have type 2 diabetes and are treated with diet and exercise alone.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
hba1c between 7.1% and 11.0%, inclusive.
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) of 23 kg/m2 to 45 kg/m2, inclusive.
boolean
C1305855 (UMLS CUI [1])
Stable body weight | Variability Percentage Timespan
Item
have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
boolean
C0517386 (UMLS CUI [1])
C2827666 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Heart Disease | Myocardial Infarction | Cardiac Arrhythmia | Angina, Unstable | Congestive heart failure Moderate | Congestive heart failure Severe | Coronary Artery Bypass Surgery | Angioplasty
Item
ave history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty
boolean
C0018799 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C0018802 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0010055 (UMLS CUI [7])
C0162577 (UMLS CUI [8])
Kidney Transplantation | Dialysis
Item
have a history of renal transplantation or are currently receiving renal dialysis
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Malignant Neoplasms | Malignant Neoplasm Untreated | Cancer Remission | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Carcinoma in situ of prostate
Item
have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
boolean
C0006826 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0687702 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0154088 (UMLS CUI [7,2])
Gastrointestinal Disease Severe | Gastroparesis
Item
have history of severe gi disorder (e.g., gastroparesis)
boolean
C0017178 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0152020 (UMLS CUI [2])
Pancreatitis | Pancreatitis, Chronic
Item
have a history of acute or chronic pancreatitis.
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Proliferative retinopathy
Item
have active proliferative retinopathy.
boolean
C0339467 (UMLS CUI [1])
Weight-Loss Agents | Xenical | orlistat | Meridia | sibutramine | Acomplia | rimonabant | Phenylpropanolamine
Item
have been treated with drugs that promote weight loss (e.g., xenical®[orlistat], meridia® [sibutramine], acomplia® [rimonabant], acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
boolean
C0376606 (UMLS CUI [1])
C0732649 (UMLS CUI [2])
C0076275 (UMLS CUI [3])
C0635898 (UMLS CUI [4])
C0074493 (UMLS CUI [5])
C2002731 (UMLS CUI [6])
C1142933 (UMLS CUI [7])
C0031495 (UMLS CUI [8])
Antidiabetics
Item
have been treated with any antidiabetic agent for more than 7 days within 3 months prior to screening.
boolean
C0935929 (UMLS CUI [1])
Organ Transplantation
Item
have had an organ transplant.
boolean
C0029216 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drug Completed | Investigational New Drug Discontinued | Patient withdrawn from trial | exenatide
Item
have previously completed or discontinued study drug in this study, withdrawn from this study or any other study investigating exenatide once weekly.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0422727 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
Pharmaceutical Preparation Approval Lacking
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C0013227 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Study Subject Participation Status
Item
are currently enrolled in any other clinical study.
boolean
C2348568 (UMLS CUI [1])
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