ID

37414

Description

Effect of Dapagliflozin on 24-hour Blood Glucose in T2DM Patients Inadequately Controlled With Either Metformin Or Insulin; ODM derived from: https://clinicaltrials.gov/show/NCT02429258

Link

https://clinicaltrials.gov/show/NCT02429258

Keywords

Versions (1)
  1. 7/24/19 7/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type II Diabetes NCT02429258

English

Eligibility Type II Diabetes NCT02429258

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus (t2dm)
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose of insulin > or = to 30 units/day and up to 2oad medications for at least 8 weeks
Description

Metformin Dose Stable U/day | Insulin Dose Stable U/day | Antidiabetics Oral Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0456683
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0456683
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C1265611
hemoglobin a1c (hba1c) 7.5% to 10.5% at screening
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
body mass index (bmi) < or = to 45 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
for patients who enter the study taking a stable dose of metformin, history of taking oad medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening
Description

Metformin Dose Stable | Antidiabetics Oral | Exception Metformin | Insulin regime

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025598
UMLS CUI [4]
C0557978
for patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 oad medications for 8 weeks prior to screening.
Description

Insulin | Therapy Except Insulin | Therapy Except Antidiabetics Oral

Data type

boolean

Alias
UMLS CUI [1]
C0021641
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0021641
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0935929
UMLS CUI [3,4]
C1527415
use of sulfonylureas during the 8 weeks prior to screening
Description

Sulfonylureas

Data type

boolean

Alias
UMLS CUI [1]
C0038766
prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (sglt-2) inhibitor
Description

Exposure to Dapagliflozin | Exposure to SGLT2 Inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2353951
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C3273807
ingestion of any medication know to affect glucose metabolism for >7 consecutive days during the 3 months prior to screening
Description

Pharmaceutical Preparations Affecting Glucose metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596620
ingestion of prescription or over the counter weight loss medication during 3 months prior to screening
Description

Weight-Loss Agents prescribed | Weight-Loss Agents Non-Prescription

Data type

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C0278329
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
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Similar models

Eligibility Type II Diabetes NCT02429258

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes mellitus (t2dm)
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Stable U/day | Insulin Dose Stable U/day | Antidiabetics Oral Quantity
Item
treated with either stable dose of metformin alone > or = to 1500mg/day or stable dose of insulin > or = to 30 units/day and up to 2oad medications for at least 8 weeks
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0021641 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
C0935929 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Hemoglobin A1c measurement
Item
hemoglobin a1c (hba1c) 7.5% to 10.5% at screening
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) < or = to 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metformin Dose Stable | Antidiabetics Oral | Exception Metformin | Insulin regime
Item
for patients who enter the study taking a stable dose of metformin, history of taking oad medications other than metformin during the 8 weeks prior to screening or have been on insulin therapy within 1 year of screening
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
C0557978 (UMLS CUI [4])
Insulin | Therapy Except Insulin | Therapy Except Antidiabetics Oral
Item
for patients who enter the study taking insulin, history of taking any other therapy outside of the stable insulin and up to 2 oad medications for 8 weeks prior to screening.
boolean
C0021641 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0935929 (UMLS CUI [3,3])
C1527415 (UMLS CUI [3,4])
Sulfonylureas
Item
use of sulfonylureas during the 8 weeks prior to screening
boolean
C0038766 (UMLS CUI [1])
Exposure to Dapagliflozin | Exposure to SGLT2 Inhibitor
Item
prior exposure to dapagliflozin or any sodium-glucose co-transporter 2 (sglt-2) inhibitor
boolean
C0332157 (UMLS CUI [1,1])
C2353951 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C3273807 (UMLS CUI [2,2])
Pharmaceutical Preparations Affecting Glucose metabolism
Item
ingestion of any medication know to affect glucose metabolism for >7 consecutive days during the 3 months prior to screening
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
Weight-Loss Agents prescribed | Weight-Loss Agents Non-Prescription
Item
ingestion of prescription or over the counter weight loss medication during 3 months prior to screening
boolean
C0376606 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
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