ID

20689

Descripción

Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00396071

Link

https://clinicaltrials.gov/show/NCT00396071

Palabras clave

Versiones (1)
  1. 11/3/17 11/3/17 -
Subido en

11 de marzo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00396071

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT00396071

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
Descripción

Non-Insulin-Dependent Diabetes Mellitus disease length | Metformin Dose Stable U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0456683
agreement to maintain the same dose of metformin throughout the study
Descripción

Metformin Dose Maintenance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0024501
body mass index (bmi) in the range of 22-35 kg/m2
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
hba1c in the range of 7.0 to 9.0%
Descripción

Glycosylated hemoglobin A Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
fpg <200 mg/dl (11.1 mmol/l)
Descripción

Plasma fasting glucose measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583513
agreement to maintain prior diet and exercise habits during the full course of the study
Descripción

Dietary Habits Maintenance | exercise habits Maintenance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0086152
UMLS CUI [1,2]
C0024501
UMLS CUI [2,1]
C2220423
UMLS CUI [2,2]
C0024501
ability to comply with all study requirements and signed informed consent to participate in the study
Descripción

Protocol Compliance | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of type 1 diabetes
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
a history of acute metabolic diabetic complications
Descripción

Complications Diabetic Metabolic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0311400
evidence of significant diabetic complications
Descripción

Complications of Diabetes Mellitus Evidence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0332120
insulin treatment for longer than 10 days within the past 6 months
Descripción

Insulin regime

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0557978
treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
Descripción

Antidiabetics Oral | Metformin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0025598
other protocol-defined inclusion/exclusion criteria may apply
Descripción

Clinical Trial Eligibility Criteria Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00396071

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus disease length | Metformin Dose Stable U/day
Item
patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Metformin Dose Maintenance
Item
agreement to maintain the same dose of metformin throughout the study
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0024501 (UMLS CUI [1,3])
Body mass index
Item
body mass index (bmi) in the range of 22-35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
hba1c in the range of 7.0 to 9.0%
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fpg <200 mg/dl (11.1 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Dietary Habits Maintenance | exercise habits Maintenance
Item
agreement to maintain prior diet and exercise habits during the full course of the study
boolean
C0086152 (UMLS CUI [1,1])
C0024501 (UMLS CUI [1,2])
C2220423 (UMLS CUI [2,1])
C0024501 (UMLS CUI [2,2])
Protocol Compliance | Informed Consent
Item
ability to comply with all study requirements and signed informed consent to participate in the study
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Complications Diabetic Metabolic
Item
a history of acute metabolic diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
Complications of Diabetes Mellitus Evidence
Item
evidence of significant diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Insulin regime
Item
insulin treatment for longer than 10 days within the past 6 months
boolean
C0557978 (UMLS CUI [1])
Antidiabetics Oral | Metformin
Item
treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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