ID

29189

Description

Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in North India and A Study to Evaluate the Efficacy of Sitagliptin (DPP-4 Inhibitor) in a Sub-group of the Study Population; ODM derived from: https://clinicaltrials.gov/show/NCT00964184

Link

https://clinicaltrials.gov/show/NCT00964184

Keywords

Versions (1)
  1. 3/5/18 3/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00964184

English

Eligibility Diabetes Mellitus, Type 2 NCT00964184

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
young (18 to 40 years) patients with diabetes (not on insulin therapy) during the past 6 months and having bmi <25 kg/m2.
Description

Age | Diabetes | Insulin regime Absent | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011847
UMLS CUI [3,1]
C0557978
UMLS CUI [3,2]
C0332197
UMLS CUI [4]
C1305855
drug naïve patients
Description

Patients Therapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0919936
patients on mono-therapy with metformin (< 1g/day).
Description

Metformin U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0456683
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
type 2 diabetes on any other oral hypoglycemic agent other than metformin
Description

Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Except Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0359086
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0025598
pregnancy or lactation
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
insulin or sulfonylurea treatment within the past 3 months
Description

Insulin | Sulfonylurea

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C0038766
has received any investigational drug with the past 60 days
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
history of prior allergy or hypersensitivity to any drug (unless approved by investigator)
Description

Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0013182
hba1c < 7.5% or > 8.5%.
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
unstable glycemic control, requiring addition of 2nd oral agent/insulin or frequent up-titration of dose of metformin.
Description

Glycaemia control Unstable | Requirement Oral medication second | Requirement Insulin second | Metformin Agent Dose Increased

Data type

boolean

Alias
UMLS CUI [1,1]
C3267174
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0175795
UMLS CUI [2,3]
C0205436
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C0205436
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C2348005
any patient on insulin.
Description

Insulin

Data type

boolean

Alias
UMLS CUI [1]
C0021641
females of child bearing potential who are not using adequate contraception during the study period.
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
insulin dependent or history of ketoacidosis requiring hospitalization
Description

Insulin Dependence | Ketoacidosis Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0439857
UMLS CUI [2,1]
C0220982
UMLS CUI [2,2]
C1708385
acute infections
Description

Communicable Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0009450
advanced end-organ damage (cld, crf etc.)
Description

End organ damage Advanced | Chronic liver disease | Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0743496
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0341439
UMLS CUI [3]
C0022661
diabetes with clinically significant or advanced end-organ damage
Description

Diabetes | End organ damage | End organ damage Advanced

Data type

boolean

Alias
UMLS CUI [1]
C0011847
UMLS CUI [2]
C0743496
UMLS CUI [3,1]
C0743496
UMLS CUI [3,2]
C0205179
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00964184

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes | Insulin regime Absent | Body mass index
Item
young (18 to 40 years) patients with diabetes (not on insulin therapy) during the past 6 months and having bmi <25 kg/m2.
boolean
C0001779 (UMLS CUI [1])
C0011847 (UMLS CUI [2])
C0557978 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1305855 (UMLS CUI [4])
Patients Therapy naive
Item
drug naïve patients
boolean
C0030705 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Metformin U/day
Item
patients on mono-therapy with metformin (< 1g/day).
boolean
C0025598 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Oral hypoglycemic Except Metformin
Item
type 2 diabetes on any other oral hypoglycemic agent other than metformin
boolean
C0011860 (UMLS CUI [1])
C0359086 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0025598 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Insulin | Sulfonylurea
Item
insulin or sulfonylurea treatment within the past 3 months
boolean
C0021641 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
Investigational New Drugs
Item
has received any investigational drug with the past 60 days
boolean
C0013230 (UMLS CUI [1])
Drug Allergy
Item
history of prior allergy or hypersensitivity to any drug (unless approved by investigator)
boolean
C0013182 (UMLS CUI [1])
Glucohemoglobin measurement
Item
hba1c < 7.5% or > 8.5%.
boolean
C0202054 (UMLS CUI [1])
Glycaemia control Unstable | Requirement Oral medication second | Requirement Insulin second | Metformin Agent Dose Increased
Item
unstable glycemic control, requiring addition of 2nd oral agent/insulin or frequent up-titration of dose of metformin.
boolean
C3267174 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0175795 (UMLS CUI [2,2])
C0205436 (UMLS CUI [2,3])
C1514873 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0205436 (UMLS CUI [3,3])
C0025598 (UMLS CUI [4,1])
C2348005 (UMLS CUI [4,2])
Insulin
Item
any patient on insulin.
boolean
C0021641 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Absent
Item
females of child bearing potential who are not using adequate contraception during the study period.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Insulin Dependence | Ketoacidosis Hospitalization Required
Item
insulin dependent or history of ketoacidosis requiring hospitalization
boolean
C0021641 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0220982 (UMLS CUI [2,1])
C1708385 (UMLS CUI [2,2])
Communicable Diseases
Item
acute infections
boolean
C0009450 (UMLS CUI [1])
End organ damage Advanced | Chronic liver disease | Kidney Failure, Chronic
Item
advanced end-organ damage (cld, crf etc.)
boolean
C0743496 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0341439 (UMLS CUI [2])
C0022661 (UMLS CUI [3])
Diabetes | End organ damage | End organ damage Advanced
Item
diabetes with clinically significant or advanced end-organ damage
boolean
C0011847 (UMLS CUI [1])
C0743496 (UMLS CUI [2])
C0743496 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
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