ID

38965

Description

A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01880736

Link

https://clinicaltrials.gov/show/NCT01880736

Keywords

Versions (1)
  1. 11/16/19 11/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01880736

English

Eligibility Diabetes NCT01880736

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01880736
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
current treatment with iglar (insulin glargine) with or without oads (oral antidiabetic drug). all antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of oads should have been stable in this period of time. - please note that a maximum of 3 oads are allowed during this trial: metformin, sulphonylurea (su)/glinides, dipeptidyl peptidase 4 (dpp-iv) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
Description

Insulin Glargine | Antidiabetics Oral Dose Stable | Antidiabetics Oral Absent | Metformin | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | pioglitazone

Data type

boolean

Alias
UMLS CUI [1]
C0907402
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C0025598
UMLS CUI [5]
C0038766
UMLS CUI [6]
C2266929
UMLS CUI [7]
C2917254
UMLS CUI [8]
C1299007
UMLS CUI [9]
C0071097
diagnosis of t2dm (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (screening visit)
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
hba1c 7.0-9.5% (both inclusive) by central laboratory analysis
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) equal to or below 35 kg/m^2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
Description

Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease At risk Protocol Compliance | Disease Severe At risk Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C1113679
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0525058
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C1444641
UMLS CUI [4,4]
C0525058
stroke; decompensated 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 the last 26 weeks prior to visit 1 (screening visit)
Description

Cerebrovascular accident | Decompensated cardiac 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]
C0581377
UMLS CUI [2,2]
C1275491
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0010055
UMLS CUI [6]
C0162577
impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dl for males and higher than or equal to 1.3 mg/dl for females
Description

Renal Insufficiency | Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
Description

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

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]
C0553723
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation
Description

Hypoglycemic Agents | Exception Inclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1512693
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Similar models

Eligibility Diabetes NCT01880736

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01880736
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Insulin Glargine | Antidiabetics Oral Dose Stable | Antidiabetics Oral Absent | Metformin | Sulfonylurea | Glinide | Dipeptidyl Peptidase 4 Inhibitors | alpha-Glucosidase Inhibitors | pioglitazone
Item
current treatment with iglar (insulin glargine) with or without oads (oral antidiabetic drug). all antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of oads should have been stable in this period of time. - please note that a maximum of 3 oads are allowed during this trial: metformin, sulphonylurea (su)/glinides, dipeptidyl peptidase 4 (dpp-iv) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
boolean
C0907402 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0025598 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C2266929 (UMLS CUI [6])
C2917254 (UMLS CUI [7])
C1299007 (UMLS CUI [8])
C0071097 (UMLS CUI [9])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
diagnosis of t2dm (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (screening visit)
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Hemoglobin A1c measurement
Item
hba1c 7.0-9.5% (both inclusive) by central laboratory analysis
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) equal to or below 35 kg/m^2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic disease At risk Patient safety | Disease Severe At risk Patient safety | Chronic disease At risk Protocol Compliance | Disease Severe At risk Protocol Compliance
Item
any chronic disorder or severe disease which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
boolean
C0008679 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
C0008679 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
Cerebrovascular accident | Decompensated cardiac failure New York Heart Association Classification | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Angioplasty
Item
stroke; decompensated 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 the last 26 weeks prior to visit 1 (screening visit)
boolean
C0038454 (UMLS CUI [1])
C0581377 (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])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dl for males and higher than or equal to 1.3 mg/dl for females
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Hypoglycemic Agents | Exception Inclusion criteria
Item
treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation
boolean
C0020616 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1512693 (UMLS CUI [2,2])
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