ID

34757

Description

A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c; ODM derived from: https://clinicaltrials.gov/show/NCT01785771

Link

https://clinicaltrials.gov/show/NCT01785771

Keywords

  1. 1/27/19 1/27/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 27, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Type 2 Diabetes NCT01785771

Eligibility Type 2 Diabetes NCT01785771

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women age 18 to 80 years with type 2 diabetes
Description

Age | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
on stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, tzd or combination of these drugs
Description

Diet therapy | Exercise | Combined Modality Therapy | Metformin Dose Stable | Sulfonylurea Dose Stable | Thiazolidinediones Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C0012159
UMLS CUI [2]
C0015259
UMLS CUI [3]
C0009429
UMLS CUI [4,1]
C0025598
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0038766
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C1257987
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
hba1c >10.0% and ≤12.0%
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with any glp-1 receptor agonist
Description

GLP-1 Receptor Agonist

Data type

boolean

Alias
UMLS CUI [1]
C2917359
history of hypersensitivity to exenatide or liraglutide
Description

Hypersensitivity Exenatide | Hypersensitivity Liraglutide

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0167117
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1456408
fpg >300 mg/dl
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
history of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
Description

Medullary carcinoma of thyroid | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type

Data type

boolean

Alias
UMLS CUI [1]
C0238462
UMLS CUI [2,1]
C0027662
UMLS CUI [2,2]
C0332307
UMLS CUI [3,1]
C4039247
UMLS CUI [3,2]
C0332307
taking dpp-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
Description

Dipeptidyl-Peptidase IV Inhibitors | Incretin mimetic product | alpha-Glucosidase Inhibitors | Meglitinide | Insulin

Data type

boolean

Alias
UMLS CUI [1]
C1827106
UMLS CUI [2]
C1562104
UMLS CUI [3]
C1299007
UMLS CUI [4]
C0065880
UMLS CUI [5]
C0021641
history of pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305

Similar models

Eligibility Type 2 Diabetes NCT01785771

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diabetes Mellitus, Non-Insulin-Dependent
Item
men or women age 18 to 80 years with type 2 diabetes
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Diet therapy | Exercise | Combined Modality Therapy | Metformin Dose Stable | Sulfonylurea Dose Stable | Thiazolidinediones Dose Stable
Item
on stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, tzd or combination of these drugs
boolean
C0012159 (UMLS CUI [1])
C0015259 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0025598 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0038766 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C1257987 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
Hemoglobin A1c measurement
Item
hba1c >10.0% and ≤12.0%
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
GLP-1 Receptor Agonist
Item
prior treatment with any glp-1 receptor agonist
boolean
C2917359 (UMLS CUI [1])
Hypersensitivity Exenatide | Hypersensitivity Liraglutide
Item
history of hypersensitivity to exenatide or liraglutide
boolean
C0020517 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1456408 (UMLS CUI [2,2])
Plasma fasting glucose measurement
Item
fpg >300 mg/dl
boolean
C0583513 (UMLS CUI [1])
Medullary carcinoma of thyroid | Multiple Endocrine Neoplasia Type | Family history of multiple endocrine neoplasia Type
Item
history of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
boolean
C0238462 (UMLS CUI [1])
C0027662 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C4039247 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Dipeptidyl-Peptidase IV Inhibitors | Incretin mimetic product | alpha-Glucosidase Inhibitors | Meglitinide | Insulin
Item
taking dpp-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
boolean
C1827106 (UMLS CUI [1])
C1562104 (UMLS CUI [2])
C1299007 (UMLS CUI [3])
C0065880 (UMLS CUI [4])
C0021641 (UMLS CUI [5])
Pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])

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