ID

23245

Beschreibung

Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea; ODM derived from: https://clinicaltrials.gov/show/NCT00327626

Link

https://clinicaltrials.gov/show/NCT00327626

Stichworte

Versionen (1)
  1. 30.06.17 30.06.17 -
Hochgeladen am

30. Juni 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00327626

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00327626

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female (post-menopausal and/or surgically sterile)
Beschreibung

Gender | Postmenopausal state | Female Sterilization

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3]
C0015787
aged 18 to 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
diagnosed with type 2 diabetes mellitus of eight years or less in duration
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
being treated with oad at stable maximum doses [defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin] for at least three months prior to screening
Beschreibung

Oral antibiotic therapy Dose Maximum Stable | Glyburide U/day | Glipizide U/day | Metformin U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0559681
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0806909
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0017628
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0017642
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0456683
having fasting plasma glucose levels of 150-270 mg/dl and hba1c levels of 7.5-11.0%
Beschreibung

Plasma fasting glucose measurement | Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0019018
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
greater than 3 severe hypoglycemic episodes within six months of screen
Beschreibung

Hypoglycaemic episode Severe Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1265611
pregnant, breastfeeding, or intends to become pregnant
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or alt greater than the upper limit of normal
Beschreibung

Sign or Symptom Liver diseases | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0023895
UMLS CUI [2]
C0019158
UMLS CUI [3]
C0019189
UMLS CUI [4]
C0151905
positive hepatitis b surface antigen, hepatitis c antibody, or hiv test
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0019699
patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin > 200 mg/day
Beschreibung

Kidney Transplantation | Dialysis | Microalbuminuria | Urine albumin level

Datentyp

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3]
C0730345
UMLS CUI [4]
C0587185
history of insulin use within three months of screen
Beschreibung

Insulin use

Datentyp

boolean

Alias
UMLS CUI [1]
C0240016
history of diabetic ketoacidosis
Beschreibung

Diabetic Ketoacidosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011880
treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
Beschreibung

Thiazolidinediones | rosiglitazone

Datentyp

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C0289313
history of lactic acidosis while on metformin therapy
Beschreibung

Acidosis, Lactic | Metformin

Datentyp

boolean

Alias
UMLS CUI [1]
C0001125
UMLS CUI [2]
C0025598
complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
Beschreibung

Complications of Diabetes Mellitus | Neuropathy | Kidney Diseases | Retinal Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2]
C0442874
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0035309
clinically significant and currently active diseases
Beschreibung

Disease Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2826293
clinical significant abnormalities in medical history, physical examination, or laboratory examination
Beschreibung

Abnormality Medical History | Abnormality Physical Examination | Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0031809
UMLS CUI [3]
C0438215
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00327626

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Postmenopausal state | Female Sterilization
Item
male or female (post-menopausal and/or surgically sterile)
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Age
Item
aged 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
diagnosed with type 2 diabetes mellitus of eight years or less in duration
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Oral antibiotic therapy Dose Maximum Stable | Glyburide U/day | Glipizide U/day | Metformin U/day
Item
being treated with oad at stable maximum doses [defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin] for at least three months prior to screening
boolean
C0559681 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0017628 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0017642 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
Plasma fasting glucose measurement | Glycosylated hemoglobin A
Item
having fasting plasma glucose levels of 150-270 mg/dl and hba1c levels of 7.5-11.0%
boolean
C0583513 (UMLS CUI [1])
C0019018 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Hypoglycaemic episode Severe Quantity
Item
greater than 3 severe hypoglycemic episodes within six months of screen
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant, breastfeeding, or intends to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Sign or Symptom Liver diseases | Hepatitis | Hepatitis, Chronic | Alanine aminotransferase increased
Item
clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or alt greater than the upper limit of normal
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0019158 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV Seropositivity
Item
positive hepatitis b surface antigen, hepatitis c antibody, or hiv test
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Kidney Transplantation | Dialysis | Microalbuminuria | Urine albumin level
Item
patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin > 200 mg/day
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0730345 (UMLS CUI [3])
C0587185 (UMLS CUI [4])
Insulin use
Item
history of insulin use within three months of screen
boolean
C0240016 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Thiazolidinediones | rosiglitazone
Item
treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
boolean
C1257987 (UMLS CUI [1])
C0289313 (UMLS CUI [2])
Acidosis, Lactic | Metformin
Item
history of lactic acidosis while on metformin therapy
boolean
C0001125 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Complications of Diabetes Mellitus | Neuropathy | Kidney Diseases | Retinal Diseases
Item
complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
boolean
C0342257 (UMLS CUI [1])
C0442874 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0035309 (UMLS CUI [4])
Disease Clinical Significance
Item
clinically significant and currently active diseases
boolean
C0012634 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Abnormality Medical History | Abnormality Physical Examination | Laboratory test result abnormal
Item
clinical significant abnormalities in medical history, physical examination, or laboratory examination
boolean
C1704258 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C0438215 (UMLS CUI [3])
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