ID

38775

Beschreibung

A Monotherapy Study to Evaluate the Efficacy and Safety of 2 Dose Levels of Albiglutide in Japanese Subjects With Type 2 Diabetes Mellitus (T2DM); ODM derived from: https://clinicaltrials.gov/show/NCT01733758

Link

https://clinicaltrials.gov/show/NCT01733758

Stichworte

Versionen (1)
  1. 03.11.19 03.11.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

3. November 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01733758

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT01733758

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with diagnosis of type 2 diabetes mellitus, treated with diet and exercise or a stable dose of 1 oad at screening
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Antidiabetics Oral Quantity | Antidiabetics Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
body mass index (bmi) 17 to 40 kg/ m^2 inclusive
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
subjects who are oad naïve, hba1c between 7.0% and 10.0% at screening and at visit 2; for subjects who enter the study with 1 oad, hba1c between 6.5% and 9.5% at screening and hba1c between 7.0% and 10.0% at visit 2
Beschreibung

Antidiabetics Oral Absent | Hemoglobin A1c measurement | Antidiabetics Oral Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0332197
UMLS CUI [2]
C0474680
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1265611
creatinine clearance >30 ml/min (calculated using the cockcroft-gault formula)
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes mellitus •female subject is pregnant, lactating, or <6 weeks postpartum•
Beschreibung

Diabetes Mellitus, Insulin-Dependent | Pregnancy | Breast Feeding | Postpartum Period

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C0086839
clinically significant cardiovascular and/or cerebrovascular disease
Beschreibung

Cardiovascular Disease | Cerebrovascular Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0007820
current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
Beschreibung

Gall Bladder Disease Symptomatic | Sign or Symptom Pancreatitis | Pancreatitis, Chronic | Pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0016977
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0030305
UMLS CUI [3]
C0149521
UMLS CUI [4]
C0030305
serum amylase >=3 ×uln and/or serum lipase >=2 × uln and/or subject is experiencing any symptoms possibly related to pancreatitis
Beschreibung

Serum amylase raised | Serum lipase raised | Symptoms Relationship Pancreatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0476327
UMLS CUI [2]
C3670924
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0030305
prior use of a tzd or glp-1r agonist within 4 months before screening
Beschreibung

Thiazolidinediones | GLP-1R Agonist

Datentyp

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2,1]
C0378073
UMLS CUI [2,2]
C2987634
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT01733758

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Antidiabetics Oral Quantity | Antidiabetics Dose Stable
Item
subjects with diagnosis of type 2 diabetes mellitus, treated with diet and exercise or a stable dose of 1 oad at screening
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0935929 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
Body mass index
Item
body mass index (bmi) 17 to 40 kg/ m^2 inclusive
boolean
C1305855 (UMLS CUI [1])
Antidiabetics Oral Absent | Hemoglobin A1c measurement | Antidiabetics Oral Quantity
Item
subjects who are oad naïve, hba1c between 7.0% and 10.0% at screening and at visit 2; for subjects who enter the study with 1 oad, hba1c between 6.5% and 9.5% at screening and hba1c between 7.0% and 10.0% at visit 2
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0474680 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance >30 ml/min (calculated using the cockcroft-gault formula)
boolean
C2711451 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Pregnancy | Breast Feeding | Postpartum Period
Item
history of type 1 diabetes mellitus •female subject is pregnant, lactating, or <6 weeks postpartum•
boolean
C0011854 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0086839 (UMLS CUI [4])
Cardiovascular Disease | Cerebrovascular Disorder
Item
clinically significant cardiovascular and/or cerebrovascular disease
boolean
C0007222 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
Gall Bladder Disease Symptomatic | Sign or Symptom Pancreatitis | Pancreatitis, Chronic | Pancreatitis
Item
current ongoing symptomatic biliary disease, clinical signs or symptoms of pancreatitis, or a history of chronic or acute pancreatitis, as determined by the investigator
boolean
C0016977 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0030305 (UMLS CUI [2,2])
C0149521 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
Serum amylase raised | Serum lipase raised | Symptoms Relationship Pancreatitis
Item
serum amylase >=3 ×uln and/or serum lipase >=2 × uln and/or subject is experiencing any symptoms possibly related to pancreatitis
boolean
C0476327 (UMLS CUI [1])
C3670924 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0030305 (UMLS CUI [3,3])
Thiazolidinediones | GLP-1R Agonist
Item
prior use of a tzd or glp-1r agonist within 4 months before screening
boolean
C1257987 (UMLS CUI [1])
C0378073 (UMLS CUI [2,1])
C2987634 (UMLS CUI [2,2])
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