ID

35764

Description

A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics; ODM derived from: https://clinicaltrials.gov/show/NCT02197520

Link

https://clinicaltrials.gov/show/NCT02197520

Keywords

Versions (1)
  1. 3/21/19 3/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02197520

English

Eligibility Diabetes Mellitus, Type 2 NCT02197520

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stable glycated hemoglobin (hba1c) less than (<) 10.0 percent (%)
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
stable dose of either 0.2 to 1.5 units per kilogram per day (u/kg/day) basal insulin or a total daily insulin dose l<2.0 units per kilogram (u/kg)
Description

Basal insulin Unit/kilogram/day | Insulin Daily Dose Unit/kilogram

Data type

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C1532634
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C2348070
UMLS CUI [2,3]
C1300561
c-peptide <0.3 nanomole per liter (nmol/l)
Description

Insulin C-peptide measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202100
stable body during the last 2 months
Description

Body Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C1268086
UMLS CUI [1,2]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
corrected qt interval (qtc) prolongation greater than (>) 500 milliseconds (ms) or have any other abnormality in the 12 lead
Description

Prolonged QTc interval | 12 lead ECG Abnormality

Data type

boolean

Alias
UMLS CUI [1]
C1560305
UMLS CUI [2,1]
C0430456
UMLS CUI [2,2]
C1704258
abnormal blood pressure
Description

Abnormal blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0005826
a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from type 1 diabetes mellitus (t1dm)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Description

Cardiovascular Diseases | Respiration Disorders | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Endocrine System Diseases | Exception Insulin-Dependent Diabetes Mellitus | Hematological Disease | Nervous system disorder | Disease Changing Drug absorption | Disease Changing Drug metabolism | Disease Changing Drug elimination | Disease Causing Investigational New Drugs At risk | Disease Interferes with Interpretation Research data

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0035204
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0014130
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0011854
UMLS CUI [8]
C0018939
UMLS CUI [9]
C0027765
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0392747
UMLS CUI [10,3]
C0678745
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0392747
UMLS CUI [11,3]
C0683140
UMLS CUI [12,1]
C0012634
UMLS CUI [12,2]
C0392747
UMLS CUI [12,3]
C0683141
UMLS CUI [13,1]
C0012634
UMLS CUI [13,2]
C0678227
UMLS CUI [13,3]
C0013230
UMLS CUI [13,4]
C1444641
UMLS CUI [14,1]
C0012634
UMLS CUI [14,2]
C0521102
UMLS CUI [14,3]
C0459471
UMLS CUI [14,4]
C0681873
currently treated with oral antidiabetic drugs (oads) (excluding metformin and dipeptidyl peptidase-4 (dpp4) inhibitors), or glucagon-like peptide-1 (glp-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect pg or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization
Description

Antidiabetics Oral | Exception Metformin | Exception DPP-4 Inhibitor | GLP-1 Receptor Agonist | Drugs, Non-Prescription | Prescription Drugs | Herbal medicine | Dietary Supplements | Pharmaceutical Preparations Affecting Plasma glucose sensitivity | Pharmaceutical Preparations Affecting Insulin sensitivity | Pharmaceutical Preparations Impact Awareness Hypoglycemia | Weight-Loss Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3537225
UMLS CUI [4]
C2917359
UMLS CUI [5]
C0013231
UMLS CUI [6]
C0304227
UMLS CUI [7]
C2240391
UMLS CUI [8]
C0242295
UMLS CUI [9,1]
C0013227
UMLS CUI [9,2]
C0392760
UMLS CUI [9,3]
C0455280
UMLS CUI [9,4]
C0020517
UMLS CUI [10,1]
C0013227
UMLS CUI [10,2]
C0392760
UMLS CUI [10,3]
C0021641
UMLS CUI [10,4]
C0020517
UMLS CUI [11,1]
C0013227
UMLS CUI [11,2]
C4049986
UMLS CUI [11,3]
C0004448
UMLS CUI [11,4]
C0020615
UMLS CUI [12]
C0376606
fasting triglycerides (tgs) >400 milligrams per deciliter (mg/dl) (4.52 millimoles per liter (mmol/l))
Description

Serum fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0582824
have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization
Description

CORTICOSTEROIDS FOR SYSTEMIC USE | Glucocorticoids Systemic | Adrenal Cortex Hormones by Inhalation | Glucocorticoids by Inhalation | Exception Topical agents | Exception Pharmaceutical Preparations Intraarticular | Exception Pharmaceutical Preparations Intraocular

Data type

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0205373
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0205535
UMLS CUI [4,1]
C0017710
UMLS CUI [4,2]
C0205535
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1710439
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C1522204
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0013227
UMLS CUI [7,3]
C1522223
currently receive insulin by pump or insulin degludec
Description

Insulin Receive Pump | Insulin degludec

Data type

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0182537
UMLS CUI [2]
C3491971
poorly controlled diabetes or known to have poor awareness of hypoglycemia
Description

Poorly controlled diabetes mellitus | Awareness Poor Hypoglycemia

Data type

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2,1]
C0004448
UMLS CUI [2,2]
C0542537
UMLS CUI [2,3]
C0020615
history of gastroparesis or gastrointestinal malabsorption
Description

Gastroparesis | Malabsorption gastrointestinal

Data type

boolean

Alias
UMLS CUI [1]
C0152020
UMLS CUI [2,1]
C3714745
UMLS CUI [2,2]
C0521362
require treatment with any drug other than insulin to treat diabetes
Description

Requirement Pharmacotherapy Diabetes Mellitus | Exception Insulin

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C0011849
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
previous history of proliferative retinopathy
Description

Proliferative retinopathy

Data type

boolean

Alias
UMLS CUI [1]
C0339467
excessive consumers of xanthines
Description

Consumer Excessive Xanthines

Data type

boolean

Alias
UMLS CUI [1,1]
C1707496
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0043318
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02197520

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hemoglobin A1c measurement
Item
stable glycated hemoglobin (hba1c) less than (<) 10.0 percent (%)
boolean
C0474680 (UMLS CUI [1])
Basal insulin Unit/kilogram/day | Insulin Daily Dose Unit/kilogram
Item
stable dose of either 0.2 to 1.5 units per kilogram per day (u/kg/day) basal insulin or a total daily insulin dose l<2.0 units per kilogram (u/kg)
boolean
C0650607 (UMLS CUI [1,1])
C1532634 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C2348070 (UMLS CUI [2,2])
C1300561 (UMLS CUI [2,3])
Insulin C-peptide measurement
Item
c-peptide <0.3 nanomole per liter (nmol/l)
boolean
C0202100 (UMLS CUI [1])
Body Stable
Item
stable body during the last 2 months
boolean
C1268086 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prolonged QTc interval | 12 lead ECG Abnormality
Item
corrected qt interval (qtc) prolongation greater than (>) 500 milliseconds (ms) or have any other abnormality in the 12 lead
boolean
C1560305 (UMLS CUI [1])
C0430456 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
Abnormal blood pressure
Item
abnormal blood pressure
boolean
C0005826 (UMLS CUI [1])
Cardiovascular Diseases | Respiration Disorders | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Endocrine System Diseases | Exception Insulin-Dependent Diabetes Mellitus | Hematological Disease | Nervous system disorder | Disease Changing Drug absorption | Disease Changing Drug metabolism | Disease Changing Drug elimination | Disease Causing Investigational New Drugs At risk | Disease Interferes with Interpretation Research data
Item
a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from type 1 diabetes mellitus (t1dm)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
boolean
C0007222 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0011854 (UMLS CUI [7,2])
C0018939 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0012634 (UMLS CUI [10,1])
C0392747 (UMLS CUI [10,2])
C0678745 (UMLS CUI [10,3])
C0012634 (UMLS CUI [11,1])
C0392747 (UMLS CUI [11,2])
C0683140 (UMLS CUI [11,3])
C0012634 (UMLS CUI [12,1])
C0392747 (UMLS CUI [12,2])
C0683141 (UMLS CUI [12,3])
C0012634 (UMLS CUI [13,1])
C0678227 (UMLS CUI [13,2])
C0013230 (UMLS CUI [13,3])
C1444641 (UMLS CUI [13,4])
C0012634 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C0459471 (UMLS CUI [14,3])
C0681873 (UMLS CUI [14,4])
Antidiabetics Oral | Exception Metformin | Exception DPP-4 Inhibitor | GLP-1 Receptor Agonist | Drugs, Non-Prescription | Prescription Drugs | Herbal medicine | Dietary Supplements | Pharmaceutical Preparations Affecting Plasma glucose sensitivity | Pharmaceutical Preparations Affecting Insulin sensitivity | Pharmaceutical Preparations Impact Awareness Hypoglycemia | Weight-Loss Agents
Item
currently treated with oral antidiabetic drugs (oads) (excluding metformin and dipeptidyl peptidase-4 (dpp4) inhibitors), or glucagon-like peptide-1 (glp-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect pg or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3537225 (UMLS CUI [3,2])
C2917359 (UMLS CUI [4])
C0013231 (UMLS CUI [5])
C0304227 (UMLS CUI [6])
C2240391 (UMLS CUI [7])
C0242295 (UMLS CUI [8])
C0013227 (UMLS CUI [9,1])
C0392760 (UMLS CUI [9,2])
C0455280 (UMLS CUI [9,3])
C0020517 (UMLS CUI [9,4])
C0013227 (UMLS CUI [10,1])
C0392760 (UMLS CUI [10,2])
C0021641 (UMLS CUI [10,3])
C0020517 (UMLS CUI [10,4])
C0013227 (UMLS CUI [11,1])
C4049986 (UMLS CUI [11,2])
C0004448 (UMLS CUI [11,3])
C0020615 (UMLS CUI [11,4])
C0376606 (UMLS CUI [12])
Serum fasting triglyceride measurement
Item
fasting triglycerides (tgs) >400 milligrams per deciliter (mg/dl) (4.52 millimoles per liter (mmol/l))
boolean
C0582824 (UMLS CUI [1])
CORTICOSTEROIDS FOR SYSTEMIC USE | Glucocorticoids Systemic | Adrenal Cortex Hormones by Inhalation | Glucocorticoids by Inhalation | Exception Topical agents | Exception Pharmaceutical Preparations Intraarticular | Exception Pharmaceutical Preparations Intraocular
Item
have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization
boolean
C3653708 (UMLS CUI [1])
C0017710 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
C0017710 (UMLS CUI [4,1])
C0205535 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1710439 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C1522204 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0013227 (UMLS CUI [7,2])
C1522223 (UMLS CUI [7,3])
Insulin Receive Pump | Insulin degludec
Item
currently receive insulin by pump or insulin degludec
boolean
C0021641 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0182537 (UMLS CUI [1,3])
C3491971 (UMLS CUI [2])
Poorly controlled diabetes mellitus | Awareness Poor Hypoglycemia
Item
poorly controlled diabetes or known to have poor awareness of hypoglycemia
boolean
C0554876 (UMLS CUI [1])
C0004448 (UMLS CUI [2,1])
C0542537 (UMLS CUI [2,2])
C0020615 (UMLS CUI [2,3])
Gastroparesis | Malabsorption gastrointestinal
Item
history of gastroparesis or gastrointestinal malabsorption
boolean
C0152020 (UMLS CUI [1])
C3714745 (UMLS CUI [2,1])
C0521362 (UMLS CUI [2,2])
Requirement Pharmacotherapy Diabetes Mellitus | Exception Insulin
Item
require treatment with any drug other than insulin to treat diabetes
boolean
C1514873 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
Proliferative retinopathy
Item
previous history of proliferative retinopathy
boolean
C0339467 (UMLS CUI [1])
Consumer Excessive Xanthines
Item
excessive consumers of xanthines
boolean
C1707496 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0043318 (UMLS CUI [1,3])
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