ID

24031

Description

Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin; ODM derived from: https://clinicaltrials.gov/show/NCT00494884

Link

https://clinicaltrials.gov/show/NCT00494884

Keywords

Versions (1)
  1. 7/23/17 7/23/17 -
Uploaded on

July 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00494884

English

Eligibility Diabetes Mellitus, Type 2 NCT00494884

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male, non-fertile female or female of childbearing potential using a medically approved birth control method
Description

Gender | Female infertility | Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0021361
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
Description

Metformin Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
agreement to maintain the same dose of metformin throughout the study
Description

Metformin Dose Same Maintenance

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0445247
UMLS CUI [1,4]
C0024501
age in the range of 18-85 years inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
hba1c in the range of 6.5 - 8.0% (inclusive) at visit 1
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
agreement to maintain prior diet and exercise habits during the full course of the study
Description

Diet Maintenance | Exercise habits Maintenance

Data type

boolean

Alias
UMLS CUI [1,1]
C0012155
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.
Description

Protocol Compliance | Informed Consent

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or lactating female
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
a history of:
Description

Medical History

Data type

boolean

Alias
UMLS CUI [1]
C0262926
type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. cushing's syndrome and acromegaly.
Description

Insulin-Dependent Diabetes Mellitus Due to Injury of pancreas | Secondary diabetes mellitus | Cushing Syndrome | Acromegaly

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0273163
UMLS CUI [2]
C0271640
UMLS CUI [3]
C0010481
UMLS CUI [4]
C0001206
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
Description

Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar state | Coma

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0311400
UMLS CUI [2]
C0220982
UMLS CUI [3]
C0236013
UMLS CUI [4]
C0009421
any of the following significant laboratory abnormalities:
Description

Laboratory test result abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0438215
alt, ast greater than 2 times the upper limit of the normal range at visit 1.
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
direct bilirubin greater than the upper limit of the normal range at visit 1.
Description

Direct bilirubin increased

Data type

boolean

Alias
UMLS CUI [1]
C0740434
serum creatinine levels equal to or greater than 1.5 mg/dl (132 umol/l) males, equal to or greater than 1.4 mg/dl (123 umol/l) females, or a history of abnormal creatinine clearance at visit 1.
Description

Creatinine measurement, serum | Gender | Creatinine clearance Abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
UMLS CUI [3,1]
C0812399
UMLS CUI [3,2]
C0205161
clinically significant tsh values outside of normal range at visit 1.
Description

Thyroid stimulating hormone Abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0040160
UMLS CUI [1,2]
C0205161
clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
Description

Laboratory test result abnormal | Hyperglycemia Excluded | Hyperinsulinism Excluded | Glycosuria Excluded | Antidiabetics Oral | Metformin Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C0020456
UMLS CUI [2,2]
C2828389
UMLS CUI [3,1]
C0020459
UMLS CUI [3,2]
C2828389
UMLS CUI [4,1]
C0017979
UMLS CUI [4,2]
C2828389
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C1527415
UMLS CUI [6,1]
C0025598
UMLS CUI [6,2]
C2828389
other protocol-defined inclusion/exclusion criteria may apply
Description

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

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

Eligibility Diabetes Mellitus, Type 2 NCT00494884

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Female infertility | Childbearing Potential Contraceptive methods
Item
male, non-fertile female or female of childbearing potential using a medically approved birth control method
boolean
C0079399 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Metformin Dose Stable
Item
patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Metformin Dose Same Maintenance
Item
agreement to maintain the same dose of metformin throughout the study
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0024501 (UMLS CUI [1,4])
Age
Item
age in the range of 18-85 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Glycosylated hemoglobin A
Item
hba1c in the range of 6.5 - 8.0% (inclusive) at visit 1
boolean
C0019018 (UMLS CUI [1])
Diet Maintenance | Exercise habits Maintenance
Item
agreement to maintain prior diet and exercise habits during the full course of the study
boolean
C0012155 (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)
Pregnancy | Breast Feeding
Item
pregnant or lactating female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical History
Item
a history of:
boolean
C0262926 (UMLS CUI [1])
Insulin-Dependent Diabetes Mellitus Due to Injury of pancreas | Secondary diabetes mellitus | Cushing Syndrome | Acromegaly
Item
type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. cushing's syndrome and acromegaly.
boolean
C0011854 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0273163 (UMLS CUI [1,3])
C0271640 (UMLS CUI [2])
C0010481 (UMLS CUI [3])
C0001206 (UMLS CUI [4])
Complications of Diabetes Mellitus Metabolic | Ketoacidosis | Hyperosmolar state | Coma
Item
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
boolean
C0342257 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0220982 (UMLS CUI [2])
C0236013 (UMLS CUI [3])
C0009421 (UMLS CUI [4])
Laboratory test result abnormal
Item
any of the following significant laboratory abnormalities:
boolean
C0438215 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
alt, ast greater than 2 times the upper limit of the normal range at visit 1.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Direct bilirubin increased
Item
direct bilirubin greater than the upper limit of the normal range at visit 1.
boolean
C0740434 (UMLS CUI [1])
Creatinine measurement, serum | Gender | Creatinine clearance Abnormal
Item
serum creatinine levels equal to or greater than 1.5 mg/dl (132 umol/l) males, equal to or greater than 1.4 mg/dl (123 umol/l) females, or a history of abnormal creatinine clearance at visit 1.
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0812399 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
Thyroid stimulating hormone Abnormal
Item
clinically significant tsh values outside of normal range at visit 1.
boolean
C0040160 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Laboratory test result abnormal | Hyperglycemia Excluded | Hyperinsulinism Excluded | Glycosuria Excluded | Antidiabetics Oral | Metformin Excluded
Item
clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
boolean
C0438215 (UMLS CUI [1])
C0020456 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0020459 (UMLS CUI [3,1])
C2828389 (UMLS CUI [3,2])
C0017979 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C1527415 (UMLS CUI [5,2])
C0025598 (UMLS CUI [6,1])
C2828389 (UMLS CUI [6,2])
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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