ID

33037

Beskrivning

Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s); ODM derived from: https://clinicaltrials.gov/show/NCT00577824

Länk

https://clinicaltrials.gov/show/NCT00577824

Nyckelord

Versioner (1)
  1. 2018-11-24 2018-11-24 -
Rättsinnehavare

See clinicaltrials.gov

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24 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00577824

Engelsk

Eligibility Type 2 Diabetes NCT00577824

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed with type 2 diabetes.
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
has been treated by sulfonylurea (su) alone, su and biguanide, or su and thiazolidinedione for at least 90 days prior to study start. in a patient receiving su alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. the patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
Beskrivning

Sulfonylurea | Biguanides | Thiazolidinediones | Sulfonylurea Dose Maximum Maintenance | Sulfonylurea Dose Maximum Approved | alpha-Glucosidase Inhibitors To be stopped | Acarbose To be stopped | Voglibose To be stopped | Miglitol To be stopped | Meglitinide Derivative To be stopped | Mitiglinide To be stopped | Nateglinide To be stopped

Datatyp

boolean

Alias
UMLS CUI [1]
C0038766
UMLS CUI [2]
C0005382
UMLS CUI [3]
C1257987
UMLS CUI [4,1]
C0038766
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0806909
UMLS CUI [4,4]
C0024501
UMLS CUI [5,1]
C0038766
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0806909
UMLS CUI [5,4]
C0205540
UMLS CUI [6,1]
C1299007
UMLS CUI [6,2]
C1272691
UMLS CUI [7,1]
C0050393
UMLS CUI [7,2]
C1272691
UMLS CUI [8,1]
C0532578
UMLS CUI [8,2]
C1272691
UMLS CUI [9,1]
C0066535
UMLS CUI [9,2]
C1272691
UMLS CUI [10,1]
C0065880
UMLS CUI [10,2]
C1527240
UMLS CUI [10,3]
C1272691
UMLS CUI [11,1]
C0906166
UMLS CUI [11,2]
C1272691
UMLS CUI [12,1]
C0903898
UMLS CUI [12,2]
C1272691
have hba1c 7.0% to 10% at study start.
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
have a body weight >=50 kg.
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Beskrivning

Off-Label Treatment

Datatyp

boolean

Alias
UMLS CUI [1]
C1096117
have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (glp-1) analogs within the last 90 days.
Beskrivning

Study Subject Participation Status | exenatide | GLP-1 analogues

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0167117
UMLS CUI [3]
C4301632
have been treated with any exogenous insulin within 90 days before study start.
Beskrivning

Insulin Exogenous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0205228
have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
Beskrivning

Pharmaceutical Preparations Affecting Gastrointestinal Motility

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0017184
the combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.
Beskrivning

Combined Modality Therapy | Sulfonylurea | Biguanides | Thiazolidinediones

Datatyp

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C0038766
UMLS CUI [3]
C0005382
UMLS CUI [4]
C1257987
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Similar models

Eligibility Type 2 Diabetes NCT00577824

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed with type 2 diabetes.
boolean
C0011860 (UMLS CUI [1])
Sulfonylurea | Biguanides | Thiazolidinediones | Sulfonylurea Dose Maximum Maintenance | Sulfonylurea Dose Maximum Approved | alpha-Glucosidase Inhibitors To be stopped | Acarbose To be stopped | Voglibose To be stopped | Miglitol To be stopped | Meglitinide Derivative To be stopped | Mitiglinide To be stopped | Nateglinide To be stopped
Item
has been treated by sulfonylurea (su) alone, su and biguanide, or su and thiazolidinedione for at least 90 days prior to study start. in a patient receiving su alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. the patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
boolean
C0038766 (UMLS CUI [1])
C0005382 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0038766 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0806909 (UMLS CUI [4,3])
C0024501 (UMLS CUI [4,4])
C0038766 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0806909 (UMLS CUI [5,3])
C0205540 (UMLS CUI [5,4])
C1299007 (UMLS CUI [6,1])
C1272691 (UMLS CUI [6,2])
C0050393 (UMLS CUI [7,1])
C1272691 (UMLS CUI [7,2])
C0532578 (UMLS CUI [8,1])
C1272691 (UMLS CUI [8,2])
C0066535 (UMLS CUI [9,1])
C1272691 (UMLS CUI [9,2])
C0065880 (UMLS CUI [10,1])
C1527240 (UMLS CUI [10,2])
C1272691 (UMLS CUI [10,3])
C0906166 (UMLS CUI [11,1])
C1272691 (UMLS CUI [11,2])
C0903898 (UMLS CUI [12,1])
C1272691 (UMLS CUI [12,2])
Hemoglobin A1c measurement
Item
have hba1c 7.0% to 10% at study start.
boolean
C0474680 (UMLS CUI [1])
Body Weight
Item
have a body weight >=50 kg.
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Off-Label Treatment
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
boolean
C1096117 (UMLS CUI [1])
Study Subject Participation Status | exenatide | GLP-1 analogues
Item
have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (glp-1) analogs within the last 90 days.
boolean
C2348568 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C4301632 (UMLS CUI [3])
Insulin Exogenous
Item
have been treated with any exogenous insulin within 90 days before study start.
boolean
C0021641 (UMLS CUI [1,1])
C0205228 (UMLS CUI [1,2])
Pharmaceutical Preparations Affecting Gastrointestinal Motility
Item
have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017184 (UMLS CUI [1,3])
Combined Modality Therapy | Sulfonylurea | Biguanides | Thiazolidinediones
Item
the combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.
boolean
C0009429 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C0005382 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
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