ID

43948

Beschrijving

A Phase 1/2a Study of the 2S,4R Enantiomer of Ketoconazole in Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00302224

Link

https://clinicaltrials.gov/show/NCT00302224

Trefwoorden

Versies (2)
  1. 03-07-17 03-07-17 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00302224

Engels

Eligibility Type 2 Diabetes NCT00302224

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female, age 18 to 70
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
2. females are non-lactating and using adequate contraception, in the opinion of the principal investigator and negative serum pregnancy test if of child bearing potential (intact uterus and pre-menopausal)
Beschrijving

Gender Breast Feeding Absent | Gender Contraceptive methods | Childbearing Potential Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0006147
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
3. diagnosis of type 2 diabetes mellitus (dm) for at least 6 months. type 2 diabetes may be untreated or may be treated with diet and exercise only and/or pharmacologic therapy as in inclusion criterion 4
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus Untreated | Diet therapy Exercise Only | Pharmacotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0332155
UMLS CUI [3,1]
C0012159
UMLS CUI [3,2]
C0015259
UMLS CUI [3,3]
C0205171
UMLS CUI [4]
C0013216
4. pharmacologic treatment for type 2 dm may include the following and must be stable for > 3 months glucophage (metformin) (< maximum dose of 2550 mg) or glucophage xr (< maximum dose of 2000 mg)
Beschrijving

Pharmacotherapy Stable Non-Insulin-Dependent Diabetes Mellitus | Glucophage Less Than Dose Maximum | Metformin Less Than Dose Maximum | Glucophage XR Less Than Dose Maximum

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0011860
UMLS CUI [2,1]
C0591573
UMLS CUI [2,2]
C0439092
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0806909
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0439092
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0806909
UMLS CUI [4,1]
C0939699
UMLS CUI [4,2]
C0439092
UMLS CUI [4,3]
C0178602
UMLS CUI [4,4]
C0806909
5. hba1c level of 6.5 to 10.9%
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
6. fasting c-peptide level of greater than or equal to 0.8 nmol/l (2.4 ng/ml)
Beschrijving

fasting C-peptide level

Datatype

boolean

Alias
UMLS CUI [1]
C2208720
7. acth stimulation test results with any cortisol level (baseline, 30 or 60 minutes) of >18 µg/dl
Beschrijving

Cosyntropin test | Cortisol level

Datatype

boolean

Alias
UMLS CUI [1]
C0201971
UMLS CUI [2]
C0428396
8. normal thyroid stimulating hormone
Beschrijving

Thyroid stimulating hormone normal

Datatype

boolean

Alias
UMLS CUI [1]
C0858305
9.12-lead electrocardiogram (ecg) shows no acute ischemia or clinically significant abnormality
Beschrijving

Ischemia Absent 12 lead ECG | Abnormality Absent 12 lead ECG

Datatype

boolean

Alias
UMLS CUI [1,1]
C0022116
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0430456
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0430456
10.bmi of 26 to 40 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
11.subjects with a history of hypertension may be on a stable anti-hypertensive regimen (except those drugs stated under exclusion criterion 7) for > 2 months
Beschrijving

Antihypertensive therapy Stable Hypertensive disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0585941
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0020538
12.ability to comprehend and a willingness to provide informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of any atherosclerotic disorder (myocardial infarction, angina, cerebrovascular accident, peripheral vascular disease or congestive heart failure secondary to ischemic myocardial injury) that would, in the estimation of the investigator, make it unsafe to stop all lipid lowering drugs during the course of the study
Beschrijving

Atherosclerosis | Myocardial Infarction | Angina Pectoris | Cerebrovascular accident | Peripheral Vascular Diseases | Congestive heart failure Secondary to Ischemic cardiomyopathy | Antilipemic agent To be stopped

Datatype

boolean

Alias
UMLS CUI [1]
C0004153
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0038454
UMLS CUI [5]
C0085096
UMLS CUI [6,1]
C0018802
UMLS CUI [6,2]
C0175668
UMLS CUI [6,3]
C0349782
UMLS CUI [7,1]
C0086440
UMLS CUI [7,2]
C1272691
2. known hypersensitivity or idiosyncratic reaction related to ketoconazole or other imidazole compounds
Beschrijving

Ketoconazole allergy | Idiosyncratic reaction Ketoconazole | Hypersensitivity Imidazole Compound | Idiosyncratic reaction Imidazole Compound

Datatype

boolean

Alias
UMLS CUI [1]
C0571275
UMLS CUI [2,1]
C0745213
UMLS CUI [2,2]
C0022625
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0020923
UMLS CUI [3,3]
C1706082
UMLS CUI [4,1]
C0745213
UMLS CUI [4,2]
C0020923
UMLS CUI [4,3]
C1706082
3. history of malignancy (except basal cell carcinoma) within the 3 years before the initial dose of the study medication
Beschrijving

Malignant Neoplasms | Basal cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
4. excessive alcohol intake or drug abuse using the diagnostic and statistical manual of mental disorders, 4th edition (dsm iv), criteria
Beschrijving

Alcohol intake above recommended sensible limits | Drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0560219
UMLS CUI [2]
C0013146
5. any other clinically significant medical condition, as determined by the investigator. these clinically significant medical conditions include proliferative diabetic retinopathy and neuropathic symptoms that limit activities of daily living
Beschrijving

Medical condition Limiting Activities of Daily Living | Proliferative diabetic retinopathy | Neuropathy Symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0001288
UMLS CUI [2]
C0154830
UMLS CUI [3,1]
C0442874
UMLS CUI [3,2]
C1457887
6. participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
7. concomitant therapy with the following: any antacid or ulcer medication, weight loss medications, oral or injected hypoglycemics (metformin is allowed) or insulin, steroids, cyclosporine, tacrolimus, midazolam, digoxin, coumarin derivatives, phenytoin, rifampin, loratadine, hiv protease inhibitors, spironolactone, thiazide diuretics, calcium channel blockers and erythromycin. subjects taking lipid lowering medications may be enrolled if investigator determines that subject does not have any conditions that preclude this cessation and subject is willing to stop such medications 21 days prior to study visit 1 through study visit 3 (day 16)
Beschrijving

Antacids | Anti-Ulcer Agent | Weight-Loss Agents | Oral hypoglycemic | Hypoglycemic Agents Injection | Metformin | Insulin | Steroids | Cyclosporine | Tacrolimus | Midazolam | Digoxin | Coumarins | Phenytoin | Rifampin | Loratadine | HIV Protease Inhibitors | Spironolactone | Thiazide Diuretics | Calcium Channel Blockers | Erythromycin | Antilipemic agent To be stopped

Datatype

boolean

Alias
UMLS CUI [1]
C0003138
UMLS CUI [2]
C0003216
UMLS CUI [3]
C0376606
UMLS CUI [4]
C0359086
UMLS CUI [5,1]
C0020616
UMLS CUI [5,2]
C1828121
UMLS CUI [6]
C0025598
UMLS CUI [7]
C0021641
UMLS CUI [8]
C0038317
UMLS CUI [9]
C0010592
UMLS CUI [10]
C0085149
UMLS CUI [11]
C0026056
UMLS CUI [12]
C0012265
UMLS CUI [13]
C0010207
UMLS CUI [14]
C0031507
UMLS CUI [15]
C0035608
UMLS CUI [16]
C0065180
UMLS CUI [17]
C0162714
UMLS CUI [18]
C0037982
UMLS CUI [19]
C0012802
UMLS CUI [20]
C0006684
UMLS CUI [21]
C0014806
UMLS CUI [22,1]
C0086440
UMLS CUI [22,2]
C1272691
8. history of hiv
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
9. positive hepatitis b (hbsag) or positive hepatitis c (hepatitis c antibody) test during screening
Beschrijving

Hepatitis B positive | Hepatitis B surface antigen positive | Hepatitis C positive | Hepatitis C antibody positive

Datatype

boolean

Alias
UMLS CUI [1]
C0856706
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
UMLS CUI [4]
C0281863
10. wbc count <4000/µl or >14,000/µl
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
11. hemoglobin <12.0 gm/dl in females and <14.0 gm/dl in males
Beschrijving

Hemoglobin measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
12. any single hepatic enzyme (alt, ast, ap and total bilirubin) is greater than the upper limit of the normal reference range used by the central laboratory
Beschrijving

Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0235996
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151849
UMLS CUI [5]
C0741494
13. creatinine > 1.5 times the upper limit of normal
Beschrijving

Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0700225
14. known hypersensitivity to cosyntropin (acth) or any component of the formulation (mannitol or sodium chloride)
Beschrijving

Hypersensitivity Cosyntropin | Hypersensitivity ACTH | Hypersensitivity ACTH Component | Mannitol allergy | Hypersensitivity Sodium Chloride

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0010192
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0001655
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0001655
UMLS CUI [3,3]
C1705248
UMLS CUI [4]
C0571922
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0037494
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Similar models

Eligibility Type 2 Diabetes NCT00302224

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female, age 18 to 70
boolean
C0001779 (UMLS CUI [1])
Gender Breast Feeding Absent | Gender Contraceptive methods | Childbearing Potential Serum pregnancy test negative
Item
2. females are non-lactating and using adequate contraception, in the opinion of the principal investigator and negative serum pregnancy test if of child bearing potential (intact uterus and pre-menopausal)
boolean
C0079399 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
Non-Insulin-Dependent Diabetes Mellitus disease length | Non-Insulin-Dependent Diabetes Mellitus Untreated | Diet therapy Exercise Only | Pharmacotherapy
Item
3. diagnosis of type 2 diabetes mellitus (dm) for at least 6 months. type 2 diabetes may be untreated or may be treated with diet and exercise only and/or pharmacologic therapy as in inclusion criterion 4
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0012159 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
C0013216 (UMLS CUI [4])
Pharmacotherapy Stable Non-Insulin-Dependent Diabetes Mellitus | Glucophage Less Than Dose Maximum | Metformin Less Than Dose Maximum | Glucophage XR Less Than Dose Maximum
Item
4. pharmacologic treatment for type 2 dm may include the following and must be stable for > 3 months glucophage (metformin) (< maximum dose of 2550 mg) or glucophage xr (< maximum dose of 2000 mg)
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0011860 (UMLS CUI [1,3])
C0591573 (UMLS CUI [2,1])
C0439092 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0806909 (UMLS CUI [2,4])
C0025598 (UMLS CUI [3,1])
C0439092 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0806909 (UMLS CUI [3,4])
C0939699 (UMLS CUI [4,1])
C0439092 (UMLS CUI [4,2])
C0178602 (UMLS CUI [4,3])
C0806909 (UMLS CUI [4,4])
Glycosylated hemoglobin A
Item
5. hba1c level of 6.5 to 10.9%
boolean
C0019018 (UMLS CUI [1])
fasting C-peptide level
Item
6. fasting c-peptide level of greater than or equal to 0.8 nmol/l (2.4 ng/ml)
boolean
C2208720 (UMLS CUI [1])
Cosyntropin test | Cortisol level
Item
7. acth stimulation test results with any cortisol level (baseline, 30 or 60 minutes) of >18 µg/dl
boolean
C0201971 (UMLS CUI [1])
C0428396 (UMLS CUI [2])
Thyroid stimulating hormone normal
Item
8. normal thyroid stimulating hormone
boolean
C0858305 (UMLS CUI [1])
Ischemia Absent 12 lead ECG | Abnormality Absent 12 lead ECG
Item
9.12-lead electrocardiogram (ecg) shows no acute ischemia or clinically significant abnormality
boolean
C0022116 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0430456 (UMLS CUI [2,3])
Body mass index
Item
10.bmi of 26 to 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Antihypertensive therapy Stable Hypertensive disease
Item
11.subjects with a history of hypertension may be on a stable anti-hypertensive regimen (except those drugs stated under exclusion criterion 7) for > 2 months
boolean
C0585941 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,3])
Informed Consent
Item
12.ability to comprehend and a willingness to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Atherosclerosis | Myocardial Infarction | Angina Pectoris | Cerebrovascular accident | Peripheral Vascular Diseases | Congestive heart failure Secondary to Ischemic cardiomyopathy | Antilipemic agent To be stopped
Item
1. history of any atherosclerotic disorder (myocardial infarction, angina, cerebrovascular accident, peripheral vascular disease or congestive heart failure secondary to ischemic myocardial injury) that would, in the estimation of the investigator, make it unsafe to stop all lipid lowering drugs during the course of the study
boolean
C0004153 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
C0085096 (UMLS CUI [5])
C0018802 (UMLS CUI [6,1])
C0175668 (UMLS CUI [6,2])
C0349782 (UMLS CUI [6,3])
C0086440 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
Ketoconazole allergy | Idiosyncratic reaction Ketoconazole | Hypersensitivity Imidazole Compound | Idiosyncratic reaction Imidazole Compound
Item
2. known hypersensitivity or idiosyncratic reaction related to ketoconazole or other imidazole compounds
boolean
C0571275 (UMLS CUI [1])
C0745213 (UMLS CUI [2,1])
C0022625 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0020923 (UMLS CUI [3,2])
C1706082 (UMLS CUI [3,3])
C0745213 (UMLS CUI [4,1])
C0020923 (UMLS CUI [4,2])
C1706082 (UMLS CUI [4,3])
Malignant Neoplasms | Basal cell carcinoma
Item
3. history of malignancy (except basal cell carcinoma) within the 3 years before the initial dose of the study medication
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
Alcohol intake above recommended sensible limits | Drug abuse
Item
4. excessive alcohol intake or drug abuse using the diagnostic and statistical manual of mental disorders, 4th edition (dsm iv), criteria
boolean
C0560219 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Medical condition Limiting Activities of Daily Living | Proliferative diabetic retinopathy | Neuropathy Symptoms
Item
5. any other clinically significant medical condition, as determined by the investigator. these clinically significant medical conditions include proliferative diabetic retinopathy and neuropathic symptoms that limit activities of daily living
boolean
C3843040 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0001288 (UMLS CUI [1,3])
C0154830 (UMLS CUI [2])
C0442874 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
Study Subject Participation Status | Investigational New Drugs
Item
6. participation in another clinical trial and/or treatment received with any investigational agent within one month before the initial dose of study medication
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Antacids | Anti-Ulcer Agent | Weight-Loss Agents | Oral hypoglycemic | Hypoglycemic Agents Injection | Metformin | Insulin | Steroids | Cyclosporine | Tacrolimus | Midazolam | Digoxin | Coumarins | Phenytoin | Rifampin | Loratadine | HIV Protease Inhibitors | Spironolactone | Thiazide Diuretics | Calcium Channel Blockers | Erythromycin | Antilipemic agent To be stopped
Item
7. concomitant therapy with the following: any antacid or ulcer medication, weight loss medications, oral or injected hypoglycemics (metformin is allowed) or insulin, steroids, cyclosporine, tacrolimus, midazolam, digoxin, coumarin derivatives, phenytoin, rifampin, loratadine, hiv protease inhibitors, spironolactone, thiazide diuretics, calcium channel blockers and erythromycin. subjects taking lipid lowering medications may be enrolled if investigator determines that subject does not have any conditions that preclude this cessation and subject is willing to stop such medications 21 days prior to study visit 1 through study visit 3 (day 16)
boolean
C0003138 (UMLS CUI [1])
C0003216 (UMLS CUI [2])
C0376606 (UMLS CUI [3])
C0359086 (UMLS CUI [4])
C0020616 (UMLS CUI [5,1])
C1828121 (UMLS CUI [5,2])
C0025598 (UMLS CUI [6])
C0021641 (UMLS CUI [7])
C0038317 (UMLS CUI [8])
C0010592 (UMLS CUI [9])
C0085149 (UMLS CUI [10])
C0026056 (UMLS CUI [11])
C0012265 (UMLS CUI [12])
C0010207 (UMLS CUI [13])
C0031507 (UMLS CUI [14])
C0035608 (UMLS CUI [15])
C0065180 (UMLS CUI [16])
C0162714 (UMLS CUI [17])
C0037982 (UMLS CUI [18])
C0012802 (UMLS CUI [19])
C0006684 (UMLS CUI [20])
C0014806 (UMLS CUI [21])
C0086440 (UMLS CUI [22,1])
C1272691 (UMLS CUI [22,2])
HIV Infection
Item
8. history of hiv
boolean
C0019693 (UMLS CUI [1])
Hepatitis B positive | Hepatitis B surface antigen positive | Hepatitis C positive | Hepatitis C antibody positive
Item
9. positive hepatitis b (hbsag) or positive hepatitis c (hepatitis c antibody) test during screening
boolean
C0856706 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
C0281863 (UMLS CUI [4])
White Blood Cell Count procedure
Item
10. wbc count <4000/µl or >14,000/µl
boolean
C0023508 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
11. hemoglobin <12.0 gm/dl in females and <14.0 gm/dl in males
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Elevated liver enzymes | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised | Elevated total bilirubin
Item
12. any single hepatic enzyme (alt, ast, ap and total bilirubin) is greater than the upper limit of the normal reference range used by the central laboratory
boolean
C0235996 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
C0741494 (UMLS CUI [5])
Serum creatinine raised
Item
13. creatinine > 1.5 times the upper limit of normal
boolean
C0700225 (UMLS CUI [1])
Hypersensitivity Cosyntropin | Hypersensitivity ACTH | Hypersensitivity ACTH Component | Mannitol allergy | Hypersensitivity Sodium Chloride
Item
14. known hypersensitivity to cosyntropin (acth) or any component of the formulation (mannitol or sodium chloride)
boolean
C0020517 (UMLS CUI [1,1])
C0010192 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0001655 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0001655 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C0571922 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0037494 (UMLS CUI [5,2])
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