ID

20691

Description

Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone; ODM derived from: https://clinicaltrials.gov/show/NCT00396357

Link

https://clinicaltrials.gov/show/NCT00396357

Keywords

Versions (1)
  1. 3/11/17 3/11/17 -
Uploaded on

March 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00396357

English

Eligibility Diabetes Mellitus, Type 2 NCT00396357

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18-78 years inclusive
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes diagnosis at least 2 months prior to study entry
Description

Non-Insulin-Dependent Diabetes Mellitus disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
body mass index in the range of 22-45 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
hba1c in the range of 6.5 to 9% inclusive
Description

Glycosylated hemoglobin A Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0439165
fasting plasma glucose <270 mg/dl (15 mmol/l)
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
evidence of significant diabetic complications
Description

Complications of Diabetes Mellitus Evidence

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0332120
treatment with insulin or any other oral antidiabetic agents
Description

Insulin | Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
congestive heart failure requiring pharmacologic treatment
Description

Congestive heart failure Requirement Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)
Description

Renal dysfunction | Metformin Labeling criteria | Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C1947902
UMLS CUI [2,3]
C0243161
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399
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 NCT00396357

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18-78 years inclusive
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
type 2 diabetes diagnosis at least 2 months prior to study entry
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Body mass index
Item
body mass index in the range of 22-45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glycosylated hemoglobin A Percentage
Item
hba1c in the range of 6.5 to 9% inclusive
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
fasting plasma glucose <270 mg/dl (15 mmol/l)
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
a history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Complications of Diabetes Mellitus Evidence
Item
evidence of significant diabetic complications
boolean
C0342257 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Insulin | Antidiabetics Oral
Item
treatment with insulin or any other oral antidiabetic agents
boolean
C0021641 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
Congestive heart failure Requirement Pharmacotherapy
Item
congestive heart failure requiring pharmacologic treatment
boolean
C0018802 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
Renal dysfunction | Metformin Labeling criteria | Creatinine measurement, serum | Gender
Item
clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels >/= 1.5 mg/dl (males) and >/= 1.4 mg/dl (females)
boolean
C3279454 (UMLS CUI [1])
C0025598 (UMLS CUI [2,1])
C1947902 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
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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