ID

25673

Beskrivning

Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00998335

Länk

https://clinicaltrials.gov/show/NCT00998335

Nyckelord

Versioner (1)
  1. 2017-09-09 2017-09-09 -
Uppladdad den

9 september 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00998335

Engelsk

Eligibility Type 2 Diabetes NCT00998335

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
to participate patients must:
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
1. be able to communicate meaningfully with the investigator and be legally competent to provide written informed consent.
Beskrivning

Able to communicate Investigator | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2364293
UMLS CUI [1,2]
C0035173
UMLS CUI [2]
C0021430
2. 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.
Beskrivning

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

Datatyp

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
3. age range of 18 to 70 years (inclusive).
Beskrivning

Age

Datatyp

boolean

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

Pharmaceutical Preparations chronic Dose Stable | Therapeutic procedure Double-Blind Method

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0013072
5. all participants must have the following laboratory values:
Beskrivning

Laboratory Results Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1514873
hemoglobin ≥ 12 g/dl in males or ≥ 11 g/dl in females
Beskrivning

Hemoglobin measurement | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
serum creatinine ≤ 1.5 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
ast (sgot) ≤ 2.5 times upper limit of normal
Beskrivning

Aspartate aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
alt (sgpt) ≤ 2.5 times upper limit of normal
Beskrivning

Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201836
alkaline phosphatase ≤ 2.5 times upper limit of normal
Beskrivning

Alkaline phosphatase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201850
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Criteria Present

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0150312
1. individuals with type 1 diabetes or type 2 diabetes and a fpg ≥ 300 mg/dl.
Beskrivning

Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Associated with Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0583513
2. subjects on sulfonylureas, metformin and/or tzds unless the dose has been stable for at least 2 months prior to study entry.
Beskrivning

Sulfonylureas | Metformin | Thiazolidinediones | Exception Dose Stable

Datatyp

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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0012802
UMLS CUI [2]
C0016860
UMLS CUI [3]
C0001645
UMLS CUI [4,1]
C0810090
UMLS CUI [4,2]
C0178665
UMLS CUI [4,3]
C0441889
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C0178602
UMLS CUI [5,4]
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]
C0205360
UMLS CUI [7,3]
C0683607
UMLS CUI [8]
C3540777
4. past (within 1 year) or current history of alcohol abuse.
Beskrivning

Alcohol abuse

Datatyp

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).
Beskrivning

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

Datatyp

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 Type 2 Diabetes NCT00998335

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status
Item
to participate patients must:
boolean
C2348568 (UMLS CUI [1])
Able to communicate Investigator | Informed Consent
Item
1. 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])
C0021430 (UMLS CUI [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
2. 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
3. age range of 18 to 70 years (inclusive).
boolean
C0001779 (UMLS CUI [1])
Pharmaceutical Preparations chronic Dose Stable | Therapeutic procedure Double-Blind Method
Item
4. patients must have been on a stable dose of allowed chronic medications for two 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])
C0087111 (UMLS CUI [2,1])
C0013072 (UMLS CUI [2,2])
Laboratory Results Required
Item
5. all participants must have the following laboratory values:
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Hemoglobin measurement | Gender
Item
hemoglobin ≥ 12 g/dl in males or ≥ 11 g/dl in females
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement
Item
ast (sgot) ≤ 2.5 times upper limit of normal
boolean
C0201899 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
alt (sgpt) ≤ 2.5 times upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Alkaline phosphatase measurement
Item
alkaline phosphatase ≤ 2.5 times upper limit of normal
boolean
C0201850 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Present
Item
patients will be excluded if any of the following criteria are present:
boolean
C0243161 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Diabetes Mellitus, Insulin-Dependent | Non-Insulin-Dependent Diabetes Mellitus Associated with Plasma fasting glucose measurement
Item
1. individuals with type 1 diabetes or type 2 diabetes and a fpg ≥ 300 mg/dl.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0583513 (UMLS CUI [2,3])
Sulfonylureas | Metformin | Thiazolidinediones | Exception Dose Stable
Item
2. subjects on sulfonylureas, metformin and/or tzds unless the dose has been stable for at least 2 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 | Adverse effects of medical drugs Glucose tolerance Level | Exception Pharmaceutical Preparations Dose Stable | Estrogens Dose Stable allowed | Hormone replacement therapy Stable 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])
C0810090 (UMLS CUI [4,1])
C0178665 (UMLS CUI [4,2])
C0441889 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C0178602 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
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])
C0205360 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
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 disease | 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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