ID

32791

Description

MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2); ODM derived from: https://clinicaltrials.gov/show/NCT00722371

Link

https://clinicaltrials.gov/show/NCT00722371

Keywords

Versions (1)
  1. 11/15/18 11/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00722371

English

Eligibility Type 2 Diabetes Mellitus NCT00722371

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is highly unlikely to conceive
Description

Pregnancy Very unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C3841878
patient meets one of the 3 categories is naïve to all antihyperglycemic agent (aha) therapies, or is non-naïve based upon the patient's current diet, medical regimen and screening a1c patient is currently not on aha with a screening a1c >=7.5 % and =<11.0
Description

Hypoglycemic Agents Therapy naive | Diet therapy | Therapy | Hemoglobin A1c measurement | Hypoglycemic Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0919936
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0087111
UMLS CUI [4]
C0474680
UMLS CUI [5,1]
C0020616
UMLS CUI [5,2]
C0332197
% patient is currently on either metformin pr sulfonylurea monotherapy with a screening a1c >=7.0 % and =<9.0 %
Description

Metformin | Sulfonylurea | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
UMLS CUI [3]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has a history of type 1 diabetes mellitus or history of ketoacidosis or has c=peptide value of =<0.8 ng/ml
Description

Diabetes Mellitus, Insulin-Dependent | Ketoacidosis | C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0220982
UMLS CUI [3]
C0202100
patient has previously been treated with insulin, thiazolidinedione (tzd) (rosiglitazone or pioglitazone), any dipeptidyl peptidase-4 (dpp-4) inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any dpp-4 inhibitor or incretin mimetic
Description

Insulin | Thiazolidinediones | rosiglitazone | pioglitazone | Dipeptidyl-Peptidase IV Inhibitors | sitagliptin | vildagliptin | alogliptin | exenatide | Study Subject Participation Status | Incretin mimetic product

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2]
C1257987
UMLS CUI [3]
C0289313
UMLS CUI [4]
C0071097
UMLS CUI [5]
C1827106
UMLS CUI [6]
C1565750
UMLS CUI [7]
C1570906
UMLS CUI [8]
C1958126
UMLS CUI [9]
C0167117
UMLS CUI [10]
C2348568
UMLS CUI [11]
C1562104
patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
Description

Weight Reduction Program | Weight-Loss Agents | orlistat | sibutramine

Data type

boolean

Alias
UMLS CUI [1]
C3179079
UMLS CUI [2]
C0376606
UMLS CUI [3]
C0076275
UMLS CUI [4]
C0074493
patient has undergone surgery within the prior 30 days 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
patient has a medical history of active liver disease including chronic active hepatitis b or c or symptomatic gallbladder disease including primary biliary cirrhosis
Description

Liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic | Gall Bladder Disease Symptomatic | Primary biliary cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
UMLS CUI [4,1]
C0016977
UMLS CUI [4,2]
C0231220
UMLS CUI [5]
C0008312
patient has received treatment with an investigational product within 12 weeks prior to visit 1
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00722371

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pregnancy Very unlikely
Item
patient is highly unlikely to conceive
boolean
C0032961 (UMLS CUI [1,1])
C3841878 (UMLS CUI [1,2])
Hypoglycemic Agents Therapy naive | Diet therapy | Therapy | Hemoglobin A1c measurement | Hypoglycemic Agents Absent
Item
patient meets one of the 3 categories is naïve to all antihyperglycemic agent (aha) therapies, or is non-naïve based upon the patient's current diet, medical regimen and screening a1c patient is currently not on aha with a screening a1c >=7.5 % and =<11.0
boolean
C0020616 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0012159 (UMLS CUI [2])
C0087111 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
C0020616 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Metformin | Sulfonylurea | Hemoglobin A1c measurement
Item
% patient is currently on either metformin pr sulfonylurea monotherapy with a screening a1c >=7.0 % and =<9.0 %
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Ketoacidosis | C-peptide measurement
Item
patient has a history of type 1 diabetes mellitus or history of ketoacidosis or has c=peptide value of =<0.8 ng/ml
boolean
C0011854 (UMLS CUI [1])
C0220982 (UMLS CUI [2])
C0202100 (UMLS CUI [3])
Insulin | Thiazolidinediones | rosiglitazone | pioglitazone | Dipeptidyl-Peptidase IV Inhibitors | sitagliptin | vildagliptin | alogliptin | exenatide | Study Subject Participation Status | Incretin mimetic product
Item
patient has previously been treated with insulin, thiazolidinedione (tzd) (rosiglitazone or pioglitazone), any dipeptidyl peptidase-4 (dpp-4) inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any dpp-4 inhibitor or incretin mimetic
boolean
C0021641 (UMLS CUI [1])
C1257987 (UMLS CUI [2])
C0289313 (UMLS CUI [3])
C0071097 (UMLS CUI [4])
C1827106 (UMLS CUI [5])
C1565750 (UMLS CUI [6])
C1570906 (UMLS CUI [7])
C1958126 (UMLS CUI [8])
C0167117 (UMLS CUI [9])
C2348568 (UMLS CUI [10])
C1562104 (UMLS CUI [11])
Weight Reduction Program | Weight-Loss Agents | orlistat | sibutramine
Item
patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
boolean
C3179079 (UMLS CUI [1])
C0376606 (UMLS CUI [2])
C0076275 (UMLS CUI [3])
C0074493 (UMLS CUI [4])
Operative Surgical Procedures | Major surgery Planned
Item
patient has undergone surgery within the prior 30 days or has major surgery planned during the study
boolean
C0543467 (UMLS CUI [1])
C0679637 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Liver disease | Hepatitis B, Chronic | Hepatitis C, Chronic | Gall Bladder Disease Symptomatic | Primary biliary cirrhosis
Item
patient has a medical history of active liver disease including chronic active hepatitis b or c or symptomatic gallbladder disease including primary biliary cirrhosis
boolean
C0023895 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
C0016977 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0008312 (UMLS CUI [5])
Investigational New Drugs
Item
patient has received treatment with an investigational product within 12 weeks prior to visit 1
boolean
C0013230 (UMLS CUI [1])
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