ID

35755

Beschrijving

Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM); ODM derived from: https://clinicaltrials.gov/show/NCT02009488

Link

https://clinicaltrials.gov/show/NCT02009488

Trefwoorden

Versies (1)
  1. 20-03-19 20-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

20 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02009488

Engels

Eligibility Diabetes Mellitus, Type 2 NCT02009488

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have a diagnosis of t2dm for at least 3 months and be on either metformin monotherapy at a stable dose of >=1,000 mg per day or on combination therapy of metformin >=1,000 mg per day and a dpp-4 inhibitor at stable daily doses for at least 12 weeks prior to screening with an hba1c of >=7.0% and <= 9.5% at screening
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length | Metformin Dose Stable U/day | Combined Modality Therapy | Dipeptidyl Peptidase-4 Inhibitor Dose Stable Daily | Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0456683
UMLS CUI [3]
C0009429
UMLS CUI [4,1]
C3537225
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [4,4]
C0332173
UMLS CUI [5]
C0474680
fasting plasma glucose >=120 mg/dl and <=240 mg/dl at the week -4 visit
Beschrijving

Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0583513
fasting fingerstick glucose >=120 mg/dl and <=240 mg/dl performed at clinical research center on day -14
Beschrijving

Fasting fingerstick blood glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C2317664
must be medically stable on the basis of clinical laboratory tests performed at screening
Beschrijving

Stable status Medical Laboratory Procedures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0022885
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or
Beschrijving

Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent | Pancreas Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0030275
β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Beschrijving

Pancreatic beta cell Transplantation | Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030281
UMLS CUI [1,2]
C0040732
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0030305
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0030279
has claustrophobia or anxiety, related to previous negative experiences with magnetic resonance imaging procedures which cannot be managed with an anxiolytic drug
Beschrijving

Claustrophobia | Anxiety Relationship Magnetic Resonance Imaging | Anti-Anxiety Agents Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2,1]
C0003467
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C0040616
UMLS CUI [3,2]
C1272705
has a history of brittle or labile glycemic control, with widely varying glucose measurements
Beschrijving

Brittle diabetes | Poor glycemic control | Glucose measurement variant

Datatype

boolean

Alias
UMLS CUI [1]
C0342302
UMLS CUI [2]
C0342299
UMLS CUI [3,1]
C0337438
UMLS CUI [3,2]
C0205419
has proliferative diabetic retinopathy (based on an eye examination within one year prior to screening), currently receiving or requiring treatment
Beschrijving

Proliferative diabetic retinopathy Eye examination | Therapeutic procedure Proliferative diabetic retinopathy | Treatment required for Proliferative diabetic retinopathy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0154830
UMLS CUI [1,2]
C0200149
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0154830
UMLS CUI [3,1]
C0332121
UMLS CUI [3,2]
C0154830
has a history of 1 or more severe hypoglycemic episodes within 6 months before screening
Beschrijving

Hypoglycaemic episode Severe Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0745153
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1265611
has history of hereditary glucose-galactose malabsorption or primary renal glucosuria.
Beschrijving

Glucose-galactose malabsorption Hereditary | Renal Glycosuria Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0268186
UMLS CUI [1,2]
C0439660
UMLS CUI [2,1]
C0017980
UMLS CUI [2,2]
C0205225
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02009488

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length | Metformin Dose Stable U/day | Combined Modality Therapy | Dipeptidyl Peptidase-4 Inhibitor Dose Stable Daily | Hemoglobin A1c measurement
Item
must have a diagnosis of t2dm for at least 3 months and be on either metformin monotherapy at a stable dose of >=1,000 mg per day or on combination therapy of metformin >=1,000 mg per day and a dpp-4 inhibitor at stable daily doses for at least 12 weeks prior to screening with an hba1c of >=7.0% and <= 9.5% at screening
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0025598 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
C0009429 (UMLS CUI [3])
C3537225 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0332173 (UMLS CUI [4,4])
C0474680 (UMLS CUI [5])
Plasma fasting glucose measurement
Item
fasting plasma glucose >=120 mg/dl and <=240 mg/dl at the week -4 visit
boolean
C0583513 (UMLS CUI [1])
Fasting fingerstick blood glucose measurement
Item
fasting fingerstick glucose >=120 mg/dl and <=240 mg/dl performed at clinical research center on day -14
boolean
C2317664 (UMLS CUI [1])
Stable status Medical Laboratory Procedures
Item
must be medically stable on the basis of clinical laboratory tests performed at screening
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent | Pancreas Transplantation
Item
has a history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or
boolean
C0011880 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0030275 (UMLS CUI [3])
Pancreatic beta cell Transplantation | Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy
Item
β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
boolean
C0030281 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0030305 (UMLS CUI [2,3])
C0011849 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0030279 (UMLS CUI [3,3])
Claustrophobia | Anxiety Relationship Magnetic Resonance Imaging | Anti-Anxiety Agents Unsuccessful
Item
has claustrophobia or anxiety, related to previous negative experiences with magnetic resonance imaging procedures which cannot be managed with an anxiolytic drug
boolean
C0008909 (UMLS CUI [1])
C0003467 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0040616 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
Brittle diabetes | Poor glycemic control | Glucose measurement variant
Item
has a history of brittle or labile glycemic control, with widely varying glucose measurements
boolean
C0342302 (UMLS CUI [1])
C0342299 (UMLS CUI [2])
C0337438 (UMLS CUI [3,1])
C0205419 (UMLS CUI [3,2])
Proliferative diabetic retinopathy Eye examination | Therapeutic procedure Proliferative diabetic retinopathy | Treatment required for Proliferative diabetic retinopathy
Item
has proliferative diabetic retinopathy (based on an eye examination within one year prior to screening), currently receiving or requiring treatment
boolean
C0154830 (UMLS CUI [1,1])
C0200149 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0154830 (UMLS CUI [2,2])
C0332121 (UMLS CUI [3,1])
C0154830 (UMLS CUI [3,2])
Hypoglycaemic episode Severe Quantity
Item
has a history of 1 or more severe hypoglycemic episodes within 6 months before screening
boolean
C0745153 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Glucose-galactose malabsorption Hereditary | Renal Glycosuria Primary
Item
has history of hereditary glucose-galactose malabsorption or primary renal glucosuria.
boolean
C0268186 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
C0017980 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
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