ID

38794

Description

A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise; ODM derived from: https://clinicaltrials.gov/show/NCT01809327

Lien

https://clinicaltrials.gov/show/NCT01809327

Mots-clés

Versions (1)
  1. 04/11/2019 04/11/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 novembre 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01809327

Anglais

Eligibility Diabetes Mellitus, Type 2 NCT01809327

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
Description

Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control Diet | Poor glycemic control Exercise

Type de données

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0342299
UMLS CUI [2,2]
C0012155
UMLS CUI [3,1]
C0342299
UMLS CUI [3,2]
C0015259
not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (hba1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
Description

Hypoglycemic Agents Absent | Hemoglobin A1c measurement Blood glucose determination by fingerstick

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0474680
UMLS CUI [2,2]
C2022094
have a screening visit hba1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
Description

Hemoglobin A1c measurement Laboratory test finding

Type de données

boolean

Alias
UMLS CUI [1,1]
C0474680
UMLS CUI [1,2]
C0587081
must have a fasting plasma glucose of less than or equal to 300 mg/dl (16.7 mmol/l) prior to randomization
Description

Plasma fasting glucose measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0583513
must have a fasting fingerstick glucose of greater than 120 mg/dl (6.7 mmol/l) performed at home or at the study center prior to randomization
Description

Fasting Blood glucose determination by fingerstick

Type de données

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C2022094
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Description

Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent | Pancreas Transplantation | Beta cell Transplantation | Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy

Type de données

boolean

Alias
UMLS CUI [1]
C0011880
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0030275
UMLS CUI [4,1]
C0030281
UMLS CUI [4,2]
C0040732
UMLS CUI [5,1]
C0011849
UMLS CUI [5,2]
C0175668
UMLS CUI [5,3]
C0030305
UMLS CUI [6,1]
C0011849
UMLS CUI [6,2]
C0175668
UMLS CUI [6,3]
C0030279
fasting c-peptide less than 0.70 ng/ml (0.23 nmol/l) in participants for whom the investigator cannot reasonably exclude t1dm based upon clinical evaluation
Description

Fasting C-peptide level | Insulin-Dependent Diabetes Mellitus Possible Clinical Evaluation

Type de données

boolean

Alias
UMLS CUI [1]
C2208720
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C0332149
UMLS CUI [2,3]
C4084924
repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dl (16.7 mmol/l) prior to randomization, despite reinforcement of diet and exercise counseling
Description

Fasting blood glucose measurement Self Monitoring Quantity | Diet counseling | Exercise counseling

Type de données

boolean

Alias
UMLS CUI [1,1]
C0428568
UMLS CUI [1,2]
C0588436
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0204932
UMLS CUI [3]
C0375886
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
Description

Congenital glucose-galactose malabsorption | Renal Glycosuria Primary

Type de données

boolean

Alias
UMLS CUI [1]
C0268186
UMLS CUI [2,1]
C0017980
UMLS CUI [2,2]
C0205225
has history of, or currently active, illness considered to be clinically significant by the investigator or any other illness that the investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Description

Illness Clinical Significance | Illness Study Subject Participation Status Excluded | Illness Interferes with Interpretation Research results

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0459471
UMLS CUI [3,4]
C0683954
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01809327

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Poor glycemic control Diet | Poor glycemic control Exercise
Item
must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
boolean
C0011860 (UMLS CUI [1])
C0342299 (UMLS CUI [2,1])
C0012155 (UMLS CUI [2,2])
C0342299 (UMLS CUI [3,1])
C0015259 (UMLS CUI [3,2])
Hypoglycemic Agents Absent | Hemoglobin A1c measurement Blood glucose determination by fingerstick
Item
not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (hba1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
boolean
C0020616 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2,1])
C2022094 (UMLS CUI [2,2])
Hemoglobin A1c measurement Laboratory test finding
Item
have a screening visit hba1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
boolean
C0474680 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Plasma fasting glucose measurement
Item
must have a fasting plasma glucose of less than or equal to 300 mg/dl (16.7 mmol/l) prior to randomization
boolean
C0583513 (UMLS CUI [1])
Fasting Blood glucose determination by fingerstick
Item
must have a fasting fingerstick glucose of greater than 120 mg/dl (6.7 mmol/l) performed at home or at the study center prior to randomization
boolean
C0015663 (UMLS CUI [1,1])
C2022094 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetic Ketoacidosis | Diabetes Mellitus, Insulin-Dependent | Pancreas Transplantation | Beta cell Transplantation | Diabetes Mellitus Secondary to Pancreatitis | Diabetes Mellitus Secondary to Pancreatectomy
Item
history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
boolean
C0011880 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0030275 (UMLS CUI [3])
C0030281 (UMLS CUI [4,1])
C0040732 (UMLS CUI [4,2])
C0011849 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])
C0030305 (UMLS CUI [5,3])
C0011849 (UMLS CUI [6,1])
C0175668 (UMLS CUI [6,2])
C0030279 (UMLS CUI [6,3])
Fasting C-peptide level | Insulin-Dependent Diabetes Mellitus Possible Clinical Evaluation
Item
fasting c-peptide less than 0.70 ng/ml (0.23 nmol/l) in participants for whom the investigator cannot reasonably exclude t1dm based upon clinical evaluation
boolean
C2208720 (UMLS CUI [1])
C0011854 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C4084924 (UMLS CUI [2,3])
Fasting blood glucose measurement Self Monitoring Quantity | Diet counseling | Exercise counseling
Item
repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dl (16.7 mmol/l) prior to randomization, despite reinforcement of diet and exercise counseling
boolean
C0428568 (UMLS CUI [1,1])
C0588436 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0204932 (UMLS CUI [2])
C0375886 (UMLS CUI [3])
Congenital glucose-galactose malabsorption | Renal Glycosuria Primary
Item
history of hereditary glucose-galactose malabsorption or primary renal glucosuria
boolean
C0268186 (UMLS CUI [1])
C0017980 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
Illness Clinical Significance | Illness Study Subject Participation Status Excluded | Illness Interferes with Interpretation Research results
Item
has history of, or currently active, illness considered to be clinically significant by the investigator or any other illness that the investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0221423 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0459471 (UMLS CUI [3,3])
C0683954 (UMLS CUI [3,4])
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