ID

25588

Beschreibung

Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-686117 in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00508287

Link

https://clinicaltrials.gov/show/NCT00508287

Stichworte

Versionen (1)
  1. 07.09.17 07.09.17 -
Hochgeladen am

7. September 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00508287

Englisch

Eligibility Type 2 Diabetes NCT00508287

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Thiazolidinediones | Sulfonylurea | Combined Modality Therapy | Diet therapy Without Pharmaceutical Preparations

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1257987
UMLS CUI [4]
C0038766
UMLS CUI [5]
C0009429
UMLS CUI [6,1]
C0012159
UMLS CUI [6,2]
C0332288
UMLS CUI [6,3]
C0013227
fasting plasma glucose: 126 - 240 mg/dl
Beschreibung

Plasma fasting glucose measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
hemoglobin a1c: 6 - 10%
Beschreibung

Glycosylated hemoglobin A

Datentyp

boolean

Alias
UMLS CUI [1]
C0019018
estimated crcl ≥ 60 ml/min
Beschreibung

Creatinine clearance measurement Estimated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0373595
UMLS CUI [1,2]
C0750572
alt ≤ 1.5 x uln and total bilirubin ≤ 2 x uln
Beschreibung

Alanine aminotransferase measurement | Serum total bilirubin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C1278039
stable and well controlled hypertension and/or dyslipidemia
Beschreibung

Hypertensive disease Stable | Hypertension controlled well | Dyslipidemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0745117
UMLS CUI [2,2]
C0205170
UMLS CUI [3]
C0242339
concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks
Beschreibung

Pharmaceutical Preparations Hypertensive disease | Pharmaceutical Preparations Dyslipidemia | Thyroid hormone replacement therapy | Aspirin Low Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0020538
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0242339
UMLS CUI [3]
C2242640
UMLS CUI [4,1]
C2608320
UMLS CUI [4,2]
C0205360
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of childbearing potential
Beschreibung

Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
symptomatic diabetes with polyuria and/or polydipsia
Beschreibung

Diabetes Mellitus Symptomatic | Polyuria | Polydipsia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0032617
UMLS CUI [3]
C0085602
history of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
Beschreibung

Diabetic Ketoacidosis | Hyperglycaemic hyperosmolar nonketotic syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C1504377
history of renal disease including diabetic nephropathy
Beschreibung

Kidney Disease | Diabetic Nephropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0011881
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Ähnliche Modelle

Eligibility Type 2 Diabetes NCT00508287

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Thiazolidinediones | Sulfonylurea | Combined Modality Therapy | Diet therapy Without Pharmaceutical Preparations
Item
diagnosis of type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve)
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C0009429 (UMLS CUI [5])
C0012159 (UMLS CUI [6,1])
C0332288 (UMLS CUI [6,2])
C0013227 (UMLS CUI [6,3])
Plasma fasting glucose measurement
Item
fasting plasma glucose: 126 - 240 mg/dl
boolean
C0583513 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hemoglobin a1c: 6 - 10%
boolean
C0019018 (UMLS CUI [1])
Creatinine clearance measurement Estimated
Item
estimated crcl ≥ 60 ml/min
boolean
C0373595 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Alanine aminotransferase measurement | Serum total bilirubin measurement
Item
alt ≤ 1.5 x uln and total bilirubin ≤ 2 x uln
boolean
C0201836 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Hypertensive disease Stable | Hypertension controlled well | Dyslipidemia
Item
stable and well controlled hypertension and/or dyslipidemia
boolean
C0020538 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0745117 (UMLS CUI [2,1])
C0205170 (UMLS CUI [2,2])
C0242339 (UMLS CUI [3])
Pharmaceutical Preparations Hypertensive disease | Pharmaceutical Preparations Dyslipidemia | Thyroid hormone replacement therapy | Aspirin Low Dose Stable
Item
concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks
boolean
C0013227 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0242339 (UMLS CUI [2,2])
C2242640 (UMLS CUI [3])
C2608320 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential
Item
women of childbearing potential
boolean
C3831118 (UMLS CUI [1])
Diabetes Mellitus Symptomatic | Polyuria | Polydipsia
Item
symptomatic diabetes with polyuria and/or polydipsia
boolean
C0011849 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0032617 (UMLS CUI [2])
C0085602 (UMLS CUI [3])
Diabetic Ketoacidosis | Hyperglycaemic hyperosmolar nonketotic syndrome
Item
history of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
boolean
C0011880 (UMLS CUI [1])
C1504377 (UMLS CUI [2])
Kidney Disease | Diabetic Nephropathy
Item
history of renal disease including diabetic nephropathy
boolean
C0022658 (UMLS CUI [1])
C0011881 (UMLS CUI [2])
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