ID

32670

Description

Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00434954

Link

https://clinicaltrials.gov/show/NCT00434954

Keywords

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

See clinicaltrials.gov

Uploaded on

November 11, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Type 2 Diabetes Mellitus NCT00434954

English

Eligibility Type 2 Diabetes Mellitus NCT00434954

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start
Description

Diet therapy | Exercise | Metformin Immediate Release Maximum Tolerated Dose Stable | Metformin Extended Release Maximum Tolerated Dose Stable | Combined Modality Therapy | Metformin | Sulfonylureas | Meglitinide

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C1708470
UMLS CUI [3,3]
C0752079
UMLS CUI [3,4]
C0205360
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C1707968
UMLS CUI [4,3]
C0752079
UMLS CUI [4,4]
C0205360
UMLS CUI [5]
C0009429
UMLS CUI [6]
C0025598
UMLS CUI [7]
C0038766
UMLS CUI [8]
C0065880
have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start
Description

Absence Thiazolidinediones chronic | Absence alpha-Glucosidase Inhibitors chronic | Absence Insulin Formulation chronic | Exception Emergency Situation

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1257987
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1299007
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C0524527
UMLS CUI [3,4]
C0205191
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0013956
have an hba1c between 6.5% and 10.0%, inclusive
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
have a body mass index (bmi) between 25 kg/m^2 and 40 kg/m^2, inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have type 1 diabetes or known latent autoimmune diabetes in adults
Description

Diabetes Mellitus, Insulin-Dependent | Latent Autoimmune Diabetes in Adults

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C1739108
are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start
Description

Systemic Glucocorticoids chronic | Exception Pharmaceutical Preparations Topical | Exception Inhalation Drug Administration | Systemic Glucocorticoids Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C3540777
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1710439
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001559
UMLS CUI [4,1]
C3540777
UMLS CUI [4,2]
C0332185
are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)
Description

Pharmacotherapy Gastrointestinal Disease | Pharmaceutical Preparations Affecting Gastrointestinal Motility | Metoclopramide | Cisapride | Macrolide Antibiotics chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0017178
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0017184
UMLS CUI [3]
C0025853
UMLS CUI [4]
C0072916
UMLS CUI [5,1]
C0003240
UMLS CUI [5,2]
C0205191
have used any prescription drug to promote weight loss within 3 months prior to study start
Description

Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1]
C0376606
have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry
Description

Pharmaceutical Preparation Without Approval

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0162696
have previously completed or withdrawn from this study or any other study investigating exenatide or glp-1 analogs
Description

Study Subject Participation Status | exenatide | GLP-1 analogues

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0167117
UMLS CUI [3]
C4301632
Back to the top of the page

Similar models

Eligibility Type 2 Diabetes Mellitus NCT00434954

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diet therapy | Exercise | Metformin Immediate Release Maximum Tolerated Dose Stable | Metformin Extended Release Maximum Tolerated Dose Stable | Combined Modality Therapy | Metformin | Sulfonylureas | Meglitinide
Item
have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0025598 (UMLS CUI [3,1])
C1708470 (UMLS CUI [3,2])
C0752079 (UMLS CUI [3,3])
C0205360 (UMLS CUI [3,4])
C0025598 (UMLS CUI [4,1])
C1707968 (UMLS CUI [4,2])
C0752079 (UMLS CUI [4,3])
C0205360 (UMLS CUI [4,4])
C0009429 (UMLS CUI [5])
C0025598 (UMLS CUI [6])
C0038766 (UMLS CUI [7])
C0065880 (UMLS CUI [8])
Absence Thiazolidinediones chronic | Absence alpha-Glucosidase Inhibitors chronic | Absence Insulin Formulation chronic | Exception Emergency Situation
Item
have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start
boolean
C0332197 (UMLS CUI [1,1])
C1257987 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1299007 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C0524527 (UMLS CUI [3,3])
C0205191 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0013956 (UMLS CUI [4,2])
Hemoglobin A1c measurement
Item
have an hba1c between 6.5% and 10.0%, inclusive
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
have a body mass index (bmi) between 25 kg/m^2 and 40 kg/m^2, inclusive
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Latent Autoimmune Diabetes in Adults
Item
have type 1 diabetes or known latent autoimmune diabetes in adults
boolean
C0011854 (UMLS CUI [1])
C1739108 (UMLS CUI [2])
Systemic Glucocorticoids chronic | Exception Pharmaceutical Preparations Topical | Exception Inhalation Drug Administration | Systemic Glucocorticoids Recently
Item
are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start
boolean
C3540777 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1710439 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0001559 (UMLS CUI [3,2])
C3540777 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
Pharmacotherapy Gastrointestinal Disease | Pharmaceutical Preparations Affecting Gastrointestinal Motility | Metoclopramide | Cisapride | Macrolide Antibiotics chronic
Item
are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)
boolean
C0013216 (UMLS CUI [1,1])
C0017178 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0017184 (UMLS CUI [2,3])
C0025853 (UMLS CUI [3])
C0072916 (UMLS CUI [4])
C0003240 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
Weight-Loss Agents
Item
have used any prescription drug to promote weight loss within 3 months prior to study start
boolean
C0376606 (UMLS CUI [1])
Pharmaceutical Preparation Without Approval
Item
have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry
boolean
C0013227 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0162696 (UMLS CUI [1,3])
Study Subject Participation Status | exenatide | GLP-1 analogues
Item
have previously completed or withdrawn from this study or any other study investigating exenatide or glp-1 analogs
boolean
C2348568 (UMLS CUI [1])
C0167117 (UMLS CUI [2])
C4301632 (UMLS CUI [3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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