ID

32900

Description

Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128); ODM derived from: https://clinicaltrials.gov/show/NCT00885352

Link

https://clinicaltrials.gov/show/NCT00885352

Keywords

Versions (1)
  1. 11/19/18 11/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00885352

English

Eligibility Type 2 Diabetes Mellitus NCT00885352

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has type 2 diabetes and is at least 18 years of age and no older than 78 years of age
Description

Diabetes Mellitus, Non-Insulin-Dependent | Age

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0001779
is male or is a female who is unlikely to conceive children
Description

Gender | Pregnancy Unlikely

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0750558
is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and metformin or metformin and a sulfonylurea agent
Description

PPAR-gamma Agonist Dose Stable | Metformin Dose Stable | Sulfonylurea Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C2917405
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0038766
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
has type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
has taken a dipeptidyl peptidase (dpp-4) inhibitor or a glucagon-like peptide-1 (glp-1) analogue
Description

Dipeptidyl-Peptidase IV Inhibitors | GLP-1 analogues

Data type

boolean

Alias
UMLS CUI [1]
C1827106
UMLS CUI [2]
C4301632
is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening
Description

Weight Reduction Program | Maintenance Phase Absent | Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1]
C3179079
UMLS CUI [2,1]
C0024501
UMLS CUI [2,2]
C0205390
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0376606
has had surgery within 30 days of screening or has major surgery planned during the study
Description

Operative Surgical Procedures | Major surgery Planned

Data type

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C1301732
is on or is likely to require treatment with corticosteroids for more than 2 weeks
Description

Adrenal Cortex Hormones | Requirement Probably Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0750492
UMLS CUI [2,3]
C0001617
has a history of active liver disease, including hepatitis b or c, cirrhosis, or gallbladder disease
Description

Liver disease | Hepatitis B | Hepatitis C | Liver Cirrhosis | Gall Bladder Disease

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0023890
UMLS CUI [5]
C0016977
is human immunodeficiency virus (hiv) positive
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening
Description

Congestive heart failure | New or Worsening Symptom Coronary heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2,1]
C3898139
UMLS CUI [2,2]
C0010068
has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening
Description

Acute Coronary Syndrome | Coronary artery Intervention | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2,1]
C0205042
UMLS CUI [2,2]
C0184661
UMLS CUI [3]
C0038454
has severe active peripheral vascular disease
Description

Peripheral Vascular Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205082
has a history of cancer or blood disorder
Description

Malignant Neoplasms | Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0018939
is pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00885352

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Age
Item
has type 2 diabetes and is at least 18 years of age and no older than 78 years of age
boolean
C0011860 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Pregnancy Unlikely
Item
is male or is a female who is unlikely to conceive children
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750558 (UMLS CUI [2,2])
PPAR-gamma Agonist Dose Stable | Metformin Dose Stable | Sulfonylurea Dose Stable
Item
is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and metformin or metformin and a sulfonylurea agent
boolean
C2917405 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0038766 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
has type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Dipeptidyl-Peptidase IV Inhibitors | GLP-1 analogues
Item
has taken a dipeptidyl peptidase (dpp-4) inhibitor or a glucagon-like peptide-1 (glp-1) analogue
boolean
C1827106 (UMLS CUI [1])
C4301632 (UMLS CUI [2])
Weight Reduction Program | Maintenance Phase Absent | Weight-Loss Agents
Item
is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening
boolean
C3179079 (UMLS CUI [1])
C0024501 (UMLS CUI [2,1])
C0205390 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0376606 (UMLS CUI [3])
Operative Surgical Procedures | Major surgery Planned
Item
has had surgery within 30 days of screening or has major surgery planned during the study
boolean
C0543467 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Adrenal Cortex Hormones | Requirement Probably Adrenal Cortex Hormones
Item
is on or is likely to require treatment with corticosteroids for more than 2 weeks
boolean
C0001617 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0750492 (UMLS CUI [2,2])
C0001617 (UMLS CUI [2,3])
Liver disease | Hepatitis B | Hepatitis C | Liver Cirrhosis | Gall Bladder Disease
Item
has a history of active liver disease, including hepatitis b or c, cirrhosis, or gallbladder disease
boolean
C0023895 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
C0016977 (UMLS CUI [5])
HIV Seropositivity
Item
is human immunodeficiency virus (hiv) positive
boolean
C0019699 (UMLS CUI [1])
Congestive heart failure | New or Worsening Symptom Coronary heart disease
Item
has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening
boolean
C0018802 (UMLS CUI [1])
C3898139 (UMLS CUI [2,1])
C0010068 (UMLS CUI [2,2])
Acute Coronary Syndrome | Coronary artery Intervention | Cerebrovascular accident
Item
has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening
boolean
C0948089 (UMLS CUI [1])
C0205042 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])
C0038454 (UMLS CUI [3])
Peripheral Vascular Disease Severe
Item
has severe active peripheral vascular disease
boolean
C0085096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Malignant Neoplasms | Hematological Disease
Item
has a history of cancer or blood disorder
boolean
C0006826 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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