ID

29240

Descrição

The Effect of Insulin Detemir in Combination With Liraglutide and Metformin Compared to Liraglutide and Metformin in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00856986

Link

https://clinicaltrials.gov/show/NCT00856986

Palavras-chave

Versões (1)
  1. 10/03/2018 10/03/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

10 de março de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetes NCT00856986

Inglês

Eligibility Diabetes NCT00856986

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00856986
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the investigator
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Insulin naive | Metformin Dose Stable U/day | Sulfonylurea Dose Stable | Allowed Insulin regime short-term Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0919936
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0456683
UMLS CUI [4,1]
C0038766
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0683607
UMLS CUI [5,2]
C0557978
UMLS CUI [5,3]
C0443303
UMLS CUI [5,4]
C0009488
hba1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
Descrição

Glucohemoglobin measurement | Metformin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2]
C0025598
hba1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea
Descrição

Glucohemoglobin measurement | Metformin | Combined Modality Therapy | Sulfonylurea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0038766
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the investigator)
Descrição

Insulin regime | Exception Therapeutic procedure short-term Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0443303
UMLS CUI [2,4]
C0009488
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
Descrição

Hypoglycemic Agents | Exception Inclusion criteria

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C1512693
recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
Descrição

Recurrent severe hypoglycemia | Loss of hypoglycemic warning

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0342316
UMLS CUI [2]
C0342317
impaired kidney function
Descrição

Renal Insufficiency

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1565489
impaired liver function
Descrição

Liver Dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0086565
uncontrolled treated/untreated hypertension
Descrição

Uncontrolled hypertension Treated | Uncontrolled hypertension untreated

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
cancer or any clinically significant disease or disorder as judged by the investigator
Descrição

Malignant Neoplasms | Disease Clinical Significance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2826293
previous participation in the run-in phase of this trial. re-screening is allowed once
Descrição

Study Subject Participation Status Run-in Period

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3274438
history of chronic pancreatitis or idiopathic pancreatitis
Descrição

Pancreatitis, Chronic | Idiopathic pancreatitis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149521
UMLS CUI [2]
C0747198
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Similar models

Eligibility Diabetes NCT00856986

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT00856986
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Insulin naive | Metformin Dose Stable U/day | Sulfonylurea Dose Stable | Allowed Insulin regime short-term Comorbidity
Item
subjects diagnosed with type 2 diabetes, insulin naïve and treated with metformin as monotherapy for at least 3 months prior to screening, at a stable dose of at least 1500 mg/day or metformin (at least 1500 mg/day) and a sulfonylurea (less than or equal to half of the maximum approved dose), both at a stable dose for at least 3 months prior to screening. previous short-term insulin treatment in connection with intercurrent illness is allowed at the discretion of the investigator
boolean
C0011860 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
C0038766 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0683607 (UMLS CUI [5,1])
C0557978 (UMLS CUI [5,2])
C0443303 (UMLS CUI [5,3])
C0009488 (UMLS CUI [5,4])
Glucohemoglobin measurement | Metformin
Item
hba1c 7.0-10.0% (both inclusive) for subjects on metformin monotherapy
boolean
C0202054 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Glucohemoglobin measurement | Metformin | Combined Modality Therapy | Sulfonylurea
Item
hba1c 7.0-8.5% (both inclusive) for subjects on metformin in combination with a sulphonylurea
boolean
C0202054 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Insulin regime | Exception Therapeutic procedure short-term Comorbidity
Item
previous treatment with insulin (except for short-term treatment in connection with intercurrent illness at the discretion of the investigator)
boolean
C0557978 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0443303 (UMLS CUI [2,3])
C0009488 (UMLS CUI [2,4])
Hypoglycemic Agents | Exception Inclusion criteria
Item
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 3 months prior to screening
boolean
C0020616 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Recurrent severe hypoglycemia | Loss of hypoglycemic warning
Item
recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator
boolean
C0342316 (UMLS CUI [1])
C0342317 (UMLS CUI [2])
Renal Insufficiency
Item
impaired kidney function
boolean
C1565489 (UMLS CUI [1])
Liver Dysfunction
Item
impaired liver function
boolean
C0086565 (UMLS CUI [1])
Uncontrolled hypertension Treated | Uncontrolled hypertension untreated
Item
uncontrolled treated/untreated hypertension
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Malignant Neoplasms | Disease Clinical Significance
Item
cancer or any clinically significant disease or disorder as judged by the investigator
boolean
C0006826 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Study Subject Participation Status Run-in Period
Item
previous participation in the run-in phase of this trial. re-screening is allowed once
boolean
C2348568 (UMLS CUI [1,1])
C3274438 (UMLS CUI [1,2])
Pancreatitis, Chronic | Idiopathic pancreatitis
Item
history of chronic pancreatitis or idiopathic pancreatitis
boolean
C0149521 (UMLS CUI [1])
C0747198 (UMLS CUI [2])
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