ID

33727

Description

The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification; ODM derived from: https://clinicaltrials.gov/show/NCT01664247

Link

https://clinicaltrials.gov/show/NCT01664247

Keywords

Versions (1)
  1. 12/21/18 12/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 21, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01664247

English

Eligibility Diabetes NCT01664247

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01664247
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
insulin naïve
Description

Insulin Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0332197
ongoing treatment with metformin or metformin in combination with either sulphonylurea (su), glinides, dipeptidyl peptidase-iv (dpp-iv) inhibitors or exenatide (only twice daily (bid))
Description

Metformin | Combined Modality Therapy | Sulfonylurea | Glinide | Dipeptidyl-Peptidase IV Inhibitors | Exenatide Twice a day

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0038766
UMLS CUI [4]
C2266929
UMLS CUI [5]
C1827106
UMLS CUI [6,1]
C0167117
UMLS CUI [6,2]
C0585361
glycosylated haemoglobin (hba1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either su, glinides, dpp-iv inhibitors or exenatide (only bid)
Description

Hemoglobin A1c measurement | Metformin | Combined Modality Therapy | Sulfonylurea | Glinide | DPP-IV Inhibitors | Exenatide Twice a day

Data type

boolean

Alias
UMLS CUI [1]
C0474680
UMLS CUI [2]
C0025598
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0038766
UMLS CUI [5]
C2266929
UMLS CUI [6]
C1827106
UMLS CUI [7,1]
C0167117
UMLS CUI [7,2]
C0585361
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
Description

Hypoglycemic Agents | Exception Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
calcitonin equal to or above 50 pg/ml
Description

Calcitonin Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0006668
UMLS CUI [1,2]
C0178602
stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
Description

Cerebrovascular accident | Heart failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0010055
UMLS CUI [6]
C0162577
current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007137
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Similar models

Eligibility Diabetes NCT01664247

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01664247
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Insulin Absent
Item
insulin naïve
boolean
C0021641 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Metformin | Combined Modality Therapy | Sulfonylurea | Glinide | Dipeptidyl-Peptidase IV Inhibitors | Exenatide Twice a day
Item
ongoing treatment with metformin or metformin in combination with either sulphonylurea (su), glinides, dipeptidyl peptidase-iv (dpp-iv) inhibitors or exenatide (only twice daily (bid))
boolean
C0025598 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0038766 (UMLS CUI [3])
C2266929 (UMLS CUI [4])
C1827106 (UMLS CUI [5])
C0167117 (UMLS CUI [6,1])
C0585361 (UMLS CUI [6,2])
Hemoglobin A1c measurement | Metformin | Combined Modality Therapy | Sulfonylurea | Glinide | DPP-IV Inhibitors | Exenatide Twice a day
Item
glycosylated haemoglobin (hba1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either su, glinides, dpp-iv inhibitors or exenatide (only bid)
boolean
C0474680 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C2266929 (UMLS CUI [5])
C1827106 (UMLS CUI [6])
C0167117 (UMLS CUI [7,1])
C0585361 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Hypoglycemic Agents | Exception Inclusion criteria
Item
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
Calcitonin Dose
Item
calcitonin equal to or above 50 pg/ml
boolean
C0006668 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Cerebrovascular accident | Heart failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
boolean
C0038454 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
C0162577 (UMLS CUI [6])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma
Item
current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007137 (UMLS CUI [3,2])
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