ID

35758

Beschreibung

A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02111096

Link

https://clinicaltrials.gov/show/NCT02111096

Stichworte

Versionen (1)
  1. 20.03.19 20.03.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. März 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02111096

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT02111096

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
have been treated with a stable dose of metformin for at least 3 months and have been treated with an optimally effective and stable dose of an sulfonylurea for at least 6 months prior to screening.
Beschreibung

Metformin Dose Stable | Sulfonylurea Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
hba1c value between 7.0% and 10.0%, inclusive.
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) between 20 and 45 kilograms/square meter (kg/m^2), inclusive.
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known type 1 diabetes mellitus.
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
more than 1 episode of severe hypoglycemia within 6 months prior to screening.
Beschreibung

Hypoglycaemic episode Severe Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1265611
two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
Beschreibung

Emergency department visit Quantity | Hospitalization Quantity | Etiology GLUCOSE CONTROL Poor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586082
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0726398
UMLS CUI [3,3]
C0542537
severe gastrointestinal disease that may significantly impact gastric emptying or motility or having undergone gastric bypass or gastric banding surgery.
Beschreibung

Gastrointestinal Disease Severe Impact Gastric Emptying | Gastrointestinal Disease Severe Impact Gastric motility | Gastric Bypass | Gastric banding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4049986
UMLS CUI [1,4]
C0017127
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C4049986
UMLS CUI [2,4]
C0232572
UMLS CUI [3]
C0017125
UMLS CUI [4]
C1960832
previous history or active diagnosis of pancreatitis.
Beschreibung

Pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
positive hepatitis b surface antigen or hepatitis c antibody.
Beschreibung

Hepatitis B surface antigen positive | Hepatitis C antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
clinical signs or symptoms of liver disease, or hepatic aminotransferases (aminotransferase or alanine aminotransferase) greater than 2.0× upper limit of normal (uln) or elevated alkaline phosphatase (greater than uln) unrelated to bone metabolic disease.
Beschreibung

Sign or Symptom Liver disease | Transaminases Hepatic Increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Independent of Metabolic Bone Disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0023895
UMLS CUI [2,1]
C0002594
UMLS CUI [2,2]
C0205054
UMLS CUI [2,3]
C0205217
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0151849
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0005944
elevated total bilirubin level (greater than uln), clinically suspicious signs/symptoms of cirrhosis or history of cirrhosis.
Beschreibung

Elevated total bilirubin | Sign or Symptom Suspicious Liver Cirrhosis | History of Liver Cirrhosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0741494
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0750493
UMLS CUI [2,3]
C0023890
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C0023890
current diagnosis, personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia (men), or von hippel-lindau.
Beschreibung

Neuroendocrine Tumors | History of Neuroendocrine Tumors | Family history of multiple endocrine neoplasia Type Any | Von Hippel-Lindau Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0206754
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0206754
UMLS CUI [3,1]
C4039247
UMLS CUI [3,2]
C0332307
UMLS CUI [3,3]
C1552551
UMLS CUI [4]
C0019562
contraindications for magnetic resonance imaging.
Beschreibung

Contraindication Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C0024485
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT02111096

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Metformin Dose Stable | Sulfonylurea Dose Stable
Item
have been treated with a stable dose of metformin for at least 3 months and have been treated with an optimally effective and stable dose of an sulfonylurea for at least 6 months prior to screening.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Hemoglobin A1c measurement
Item
hba1c value between 7.0% and 10.0%, inclusive.
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 20 and 45 kilograms/square meter (kg/m^2), inclusive.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
known type 1 diabetes mellitus.
boolean
C0011854 (UMLS CUI [1])
Hypoglycaemic episode Severe Quantity
Item
more than 1 episode of severe hypoglycemia within 6 months prior to screening.
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Emergency department visit Quantity | Hospitalization Quantity | Etiology GLUCOSE CONTROL Poor
Item
two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
boolean
C0586082 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0726398 (UMLS CUI [3,2])
C0542537 (UMLS CUI [3,3])
Gastrointestinal Disease Severe Impact Gastric Emptying | Gastrointestinal Disease Severe Impact Gastric motility | Gastric Bypass | Gastric banding
Item
severe gastrointestinal disease that may significantly impact gastric emptying or motility or having undergone gastric bypass or gastric banding surgery.
boolean
C0017178 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4049986 (UMLS CUI [1,3])
C0017127 (UMLS CUI [1,4])
C0017178 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4049986 (UMLS CUI [2,3])
C0232572 (UMLS CUI [2,4])
C0017125 (UMLS CUI [3])
C1960832 (UMLS CUI [4])
Pancreatitis
Item
previous history or active diagnosis of pancreatitis.
boolean
C0030305 (UMLS CUI [1])
Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
positive hepatitis b surface antigen or hepatitis c antibody.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
Sign or Symptom Liver disease | Transaminases Hepatic Increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Independent of Metabolic Bone Disorder
Item
clinical signs or symptoms of liver disease, or hepatic aminotransferases (aminotransferase or alanine aminotransferase) greater than 2.0× upper limit of normal (uln) or elevated alkaline phosphatase (greater than uln) unrelated to bone metabolic disease.
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0002594 (UMLS CUI [2,1])
C0205054 (UMLS CUI [2,2])
C0205217 (UMLS CUI [2,3])
C0151905 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
C0332291 (UMLS CUI [5,1])
C0005944 (UMLS CUI [5,2])
Elevated total bilirubin | Sign or Symptom Suspicious Liver Cirrhosis | History of Liver Cirrhosis
Item
elevated total bilirubin level (greater than uln), clinically suspicious signs/symptoms of cirrhosis or history of cirrhosis.
boolean
C0741494 (UMLS CUI [1])
C3540840 (UMLS CUI [2,1])
C0750493 (UMLS CUI [2,2])
C0023890 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0023890 (UMLS CUI [3,2])
Neuroendocrine Tumors | History of Neuroendocrine Tumors | Family history of multiple endocrine neoplasia Type Any | Von Hippel-Lindau Syndrome
Item
current diagnosis, personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia (men), or von hippel-lindau.
boolean
C0206754 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0206754 (UMLS CUI [2,2])
C4039247 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
C1552551 (UMLS CUI [3,3])
C0019562 (UMLS CUI [4])
Contraindication Magnetic Resonance Imaging
Item
contraindications for magnetic resonance imaging.
boolean
C0522473 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
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