ID

32791

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00722371

Nyckelord

Versioner (1)
  1. 2018-11-15 2018-11-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 november 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Type 2 Diabetes Mellitus NCT00722371

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00722371

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is highly unlikely to conceive
Beskrivning

Pregnancy Very unlikely

Datatyp

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
Beskrivning

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

Datatyp

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 %
Beskrivning

Metformin | Sulfonylurea | Hemoglobin A1c measurement

Datatyp

boolean

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

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Operative Surgical Procedures | Major surgery Planned

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
Tillbaka till toppen

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00722371

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial