ID

16108

Description

A Comparison of Exenatide and Insulin Glargine on Glycemic Variability in Type 2 Diabetes Patients Inadequately Controlled With Metformin Monotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT02325960

Link

https://clinicaltrials.gov/show/NCT02325960

Keywords

Versions (1)
  1. 6/29/16 6/29/16 -
Uploaded on

June 29, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT02325960

English

Eligibility Type 2 Diabetes NCT02325960

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of informed consent prior to any study specific procedures
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
Description

Diabetes Mellitus, Non-Insulin-Dependent | Metformin Maximum Dosage Stable

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0806909
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
3. male or female age ≧ 18 years and ≦70 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. hba1c ≧7.0 and ≦10%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
5. bmi ≧ 24 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known or suspected allergy to trial products or related products.
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Related Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0013227
2. impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 133 umol/l).
Description

Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
3. acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock.
Description

Disease Causing Tissue hypoxia | Respiratory Failure | Shock

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C4061096
UMLS CUI [2]
C1145670
UMLS CUI [3]
C0036974
4. abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism.
Description

Liver Dysfunction | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement | Acute alcoholic intoxication | Alcoholic Intoxication, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201913
UMLS CUI [5]
C0394996
UMLS CUI [6]
C0001973
5. subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (mi), arrhythmias or conduction delays on ecg, unstable angina, or decompensated heart failure (new york heart association-class ⅲ and ⅳ).
Description

Cardiovascular Diseases Clinical Significance | Myocardial Infarction | Cardiac Arrhythmia | Electrocardiography Conduction delay | Angina, Unstable | Decompensated cardiac failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0003811
UMLS CUI [4,1]
C1623258
UMLS CUI [4,2]
C1398354
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0581377
6. proliferative retinopathy or muscular oedema requiring acute treatment.
Description

Proliferative retinopathy Requirement Therapeutic procedure | Muscular edema Requirement Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C4021979
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0087111
7. pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
Description

Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0558080
UMLS CUI [5]
C0015787
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C0004764
8. treatment with systemic corticosteroids within the past two months prior to screening.
Description

Therapeutic procedure systemic steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2825233
9. type 1 diabetes mellitus.
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
10. receipt of any investigational drug within 1 month prior to this trial.
Description

Investigational New Drugs Use

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524063
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Similar models

Eligibility Type 2 Diabetes NCT02325960

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
1. provision of informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin Maximum Dosage Stable
Item
2. type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C0806909 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Age
Item
3. male or female age ≧ 18 years and ≦70 years old
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
4. hba1c ≧7.0 and ≦10%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
5. bmi ≧ 24 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Related Pharmaceutical Preparations
Item
1. known or suspected allergy to trial products or related products.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
Renal Insufficiency | Creatinine measurement, serum
Item
2. impaired renal function defined as serum-creatinine ≥ 1.5 mg/dl (≥ 133 umol/l).
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Disease Causing Tissue hypoxia | Respiratory Failure | Shock
Item
3. acute or chronic disease which may cause tissue hypoxia such as respiratory failure or shock.
boolean
C0012634 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C4061096 (UMLS CUI [1,3])
C1145670 (UMLS CUI [2])
C0036974 (UMLS CUI [3])
Liver Dysfunction | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Bilirubin, total measurement | Acute alcoholic intoxication | Alcoholic Intoxication, Chronic
Item
4. abnormal liver function, alanine transaminase or aspartate aminotransferase ≥ 3 fold normal upper limit, total bilirubin ≥ 2 normal upper limit, acute alcohol intoxication, alcoholism.
boolean
C0086565 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201913 (UMLS CUI [4])
C0394996 (UMLS CUI [5])
C0001973 (UMLS CUI [6])
Cardiovascular Diseases Clinical Significance | Myocardial Infarction | Cardiac Arrhythmia | Electrocardiography Conduction delay | Angina, Unstable | Decompensated cardiac failure
Item
5. subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (mi), arrhythmias or conduction delays on ecg, unstable angina, or decompensated heart failure (new york heart association-class ⅲ and ⅳ).
boolean
C0007222 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C1623258 (UMLS CUI [4,1])
C1398354 (UMLS CUI [4,2])
C0002965 (UMLS CUI [5])
C0581377 (UMLS CUI [6])
Proliferative retinopathy Requirement Therapeutic procedure | Muscular edema Requirement Therapeutic procedure
Item
6. proliferative retinopathy or muscular oedema requiring acute treatment.
boolean
C0339467 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C4021979 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
Pregnancy | Pregnancy test positive | Breast Feeding | Contraceptive methods Unwilling | Female Sterilization | Intrauterine Devices | Contraceptives, Oral | Contraception, Barrier
Item
7. pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0015787 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C0004764 (UMLS CUI [8])
Therapeutic procedure systemic steroids
Item
8. treatment with systemic corticosteroids within the past two months prior to screening.
boolean
C0087111 (UMLS CUI [1,1])
C2825233 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent
Item
9. type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Investigational New Drugs Use
Item
10. receipt of any investigational drug within 1 month prior to this trial.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
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