ID

31066

Description

Adding Exenatide to Insulin Therapy for Patients With Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01006889

Link

https://clinicaltrials.gov/show/NCT01006889

Keywords

Versions (1)
  1. 7/16/18 7/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 16, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Nonalcoholic Fatty Liver Disease NCT01006889

English

Eligibility Nonalcoholic Fatty Liver Disease NCT01006889

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
to enter the study subjects must meet the following criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. have been on intensified insulin therapy with insulin detemir (levemir) and premeal insulin aspart (novolog®) for the previous 6 months.
Description

Insulin regime intense | Insulin detemir | Levemir | Insulin Aspart pre-meal | NovoLog

Data type

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0522510
UMLS CUI [2]
C0537270
UMLS CUI [3]
C1314782
UMLS CUI [4,1]
C1708521
UMLS CUI [4,2]
C1546096
UMLS CUI [5]
C0939412
2. be able to communicate meaningfully with the investigator and be legally competent to provide written informed consent.
Description

Able to communicate Investigator | Legal competency Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2,1]
C0680554
UMLS CUI [2,2]
C0021430
3. female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). female patients who have undergone a hysterectomy are eligible for participation in the study. female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
Description

Gender Breast Feeding Absent | Postmenopausal state | Gender Contraceptive methods | Contraceptives, Oral | Hormone implant | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Gender Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0848131
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0042241
UMLS CUI [8]
C0087145
UMLS CUI [9]
C0221829
UMLS CUI [10]
C0015787
UMLS CUI [11]
C0589114
UMLS CUI [12]
C0278321
UMLS CUI [13]
C0020699
UMLS CUI [14,1]
C0079399
UMLS CUI [14,2]
C0427780
4. age range of 18 to 70 years (inclusive).
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. patients must have been on a stable dose of allowed chronic medications for 6 months prior to entering the double-blind treatment period.
Description

Pharmaceutical Preparations chronic Dose Stable | Double-Blind Method

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2]
C0013072
6. all participants must have the following laboratory values:
Description

Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C1254595
hemoglobin ≥12 g/dl in males or ≥11 g/dl in females serum creatinine ≤1.5 mg/dl ast (sgot) and alt (sgpt) ≤2.5 times upper limit of normal alkaline phosphatase ≤2.5 times upper limit of normal
Description

Hemoglobin measurement | Gender | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0201899
UMLS CUI [5]
C0201836
UMLS CUI [6]
C0201850
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded if any of the following criteria are present:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. individuals with type 1 diabetes or type 2 diabetes and a fpg ≥ 300 mg/dl; poor compliance with insulin therapy.
Description

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Plasma fasting glucose measurement | Insulin regime Poor compliance

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0583513
UMLS CUI [4,1]
C0557978
UMLS CUI [4,2]
C0032646
2. subjects on sulfonylureas, metformin and/or tzds unless the dose has been stable for at least 6 months prior to study entry.
Description

Sulfonylureas | Metformin | Thiazolidinediones | Exception Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1257987
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
3. patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. patients taking systemic glucocorticoids will be excluded.
Description

Thiazide Diuretics | Furosemide | Adrenergic beta-Antagonists | Pharmaceutical Preparations chronic Adverse effects Glucose tolerance | Exception Dose Stable | Estrogens Dose Stable allowed | Hormone replacement therapy allowed | Glucocorticoids, Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0012802
UMLS CUI [2]
C0016860
UMLS CUI [3]
C0001645
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0205191
UMLS CUI [4,3]
C0879626
UMLS CUI [4,4]
C0178665
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C0014939
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [6,4]
C0683607
UMLS CUI [7,1]
C0282402
UMLS CUI [7,2]
C0683607
UMLS CUI [8]
C3540777
4. past (within 1 year) or current history of alcohol abuse.
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
5. patients will be excluded if there is a history of clinically significant heart disease (new york heart classification greater than grade ii), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
Description

Heart Disease New York Heart Association Classification | Peripheral Vascular Disease | Claudication | Lung diseases | Dyspnea on exertion | Abnormal breath sounds Auscultation | Kidney Failure, Chronic | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0085096
UMLS CUI [3]
C1456822
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0231807
UMLS CUI [6,1]
C0231856
UMLS CUI [6,2]
C0004339
UMLS CUI [7]
C0022661
UMLS CUI [8]
C0201976
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Similar models

Eligibility Nonalcoholic Fatty Liver Disease NCT01006889

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
to enter the study subjects must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Insulin regime intense | Insulin detemir | Levemir | Insulin Aspart pre-meal | NovoLog
Item
1. have been on intensified insulin therapy with insulin detemir (levemir) and premeal insulin aspart (novolog®) for the previous 6 months.
boolean
C0557978 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C0537270 (UMLS CUI [2])
C1314782 (UMLS CUI [3])
C1708521 (UMLS CUI [4,1])
C1546096 (UMLS CUI [4,2])
C0939412 (UMLS CUI [5])
Able to communicate Investigator | Legal competency Informed Consent
Item
2. be able to communicate meaningfully with the investigator and be legally competent to provide written informed consent.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0680554 (UMLS CUI [2,1])
C0021430 (UMLS CUI [2,2])
Gender Breast Feeding Absent | Postmenopausal state | Gender Contraceptive methods | Contraceptives, Oral | Hormone implant | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Female Condoms | Female Sterilization | Bilateral tubal ligation | Bilateral oophorectomy | Hysterectomy | Gender Pregnancy test negative
Item
3. female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). female patients who have undergone a hysterectomy are eligible for participation in the study. female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4])
C0848131 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0221829 (UMLS CUI [9])
C0015787 (UMLS CUI [10])
C0589114 (UMLS CUI [11])
C0278321 (UMLS CUI [12])
C0020699 (UMLS CUI [13])
C0079399 (UMLS CUI [14,1])
C0427780 (UMLS CUI [14,2])
Age
Item
4. age range of 18 to 70 years (inclusive).
boolean
C0001779 (UMLS CUI [1])
Pharmaceutical Preparations chronic Dose Stable | Double-Blind Method
Item
5. patients must have been on a stable dose of allowed chronic medications for 6 months prior to entering the double-blind treatment period.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0013072 (UMLS CUI [2])
Laboratory Results
Item
6. all participants must have the following laboratory values:
boolean
C1254595 (UMLS CUI [1])
Hemoglobin measurement | Gender | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
hemoglobin ≥12 g/dl in males or ≥11 g/dl in females serum creatinine ≤1.5 mg/dl ast (sgot) and alt (sgpt) ≤2.5 times upper limit of normal alkaline phosphatase ≤2.5 times upper limit of normal
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201836 (UMLS CUI [5])
C0201850 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will be excluded if any of the following criteria are present:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Plasma fasting glucose measurement | Insulin regime Poor compliance
Item
1. individuals with type 1 diabetes or type 2 diabetes and a fpg ≥ 300 mg/dl; poor compliance with insulin therapy.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0583513 (UMLS CUI [3])
C0557978 (UMLS CUI [4,1])
C0032646 (UMLS CUI [4,2])
Sulfonylureas | Metformin | Thiazolidinediones | Exception Dose Stable
Item
2. subjects on sulfonylureas, metformin and/or tzds unless the dose has been stable for at least 6 months prior to study entry.
boolean
C0038766 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Thiazide Diuretics | Furosemide | Adrenergic beta-Antagonists | Pharmaceutical Preparations chronic Adverse effects Glucose tolerance | Exception Dose Stable | Estrogens Dose Stable allowed | Hormone replacement therapy allowed | Glucocorticoids, Systemic
Item
3. patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. patients taking systemic glucocorticoids will be excluded.
boolean
C0012802 (UMLS CUI [1])
C0016860 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0879626 (UMLS CUI [4,3])
C0178665 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0014939 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0683607 (UMLS CUI [6,4])
C0282402 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C3540777 (UMLS CUI [8])
Alcohol abuse
Item
4. past (within 1 year) or current history of alcohol abuse.
boolean
C0085762 (UMLS CUI [1])
Heart Disease New York Heart Association Classification | Peripheral Vascular Disease | Claudication | Lung diseases | Dyspnea on exertion | Abnormal breath sounds Auscultation | Kidney Failure, Chronic | Creatinine measurement, serum
Item
5. patients will be excluded if there is a history of clinically significant heart disease (new york heart classification greater than grade ii), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0085096 (UMLS CUI [2])
C1456822 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0231807 (UMLS CUI [5])
C0231856 (UMLS CUI [6,1])
C0004339 (UMLS CUI [6,2])
C0022661 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
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