ID

32718

Description

A Placebo Controlled Safety and Efficacy Study of INT131 Besylate in Type 2 Diabetes, With an Active Comparator; ODM derived from: https://clinicaltrials.gov/show/NCT00631007

Link

https://clinicaltrials.gov/show/NCT00631007

Keywords

Versions (1)
  1. 11/13/18 11/13/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 13, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00631007

English

Eligibility Type 2 Diabetes Mellitus NCT00631007

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
Description

Diabetes Mellitus, Non-Insulin-Dependent | Sulfonylureas Dose Stable | Metformin Dose Stable | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0038766
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4]
C0009429
males and females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
Description

Age | Female infertility | Gender Barrier Contraception Double

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021361
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0004764
UMLS CUI [3,3]
C0205173
hba1c must be ≥7.5% and ≤10% at screening
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
fasting plasma glucose must be <240 mg/dl at screening
Description

Plasma fasting glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583513
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of type 1 diabetes
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
history of diabetic ketoacidosis
Description

Diabetic Ketoacidosis

Data type

boolean

Alias
UMLS CUI [1]
C0011880
nyha class iii or iv cardiac status or hospitalization for congestive heart failure within 6 weeks prior to visit 1
Description

Cardiac Status New York Heart Association Classification | Hospitalization Due to Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0018802
treatment with any non-peroxisome proliferator-activated receptor (non-ppar) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
Description

Antidiabetics Investigational | Antidiabetics Approved | Exception Peroxisome Proliferator-Activated Receptors | Exception Metformin | Exception Sulfonylureas

Data type

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1517586
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0205540
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0166418
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0025598
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0038766
treatment with rosiglitazone, pioglitazone, or any ppar investigational antidiabetic agent within 6 month prior to screening
Description

rosiglitazone | pioglitazone | Antidiabetics Investigational PPAR

Data type

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0071097
UMLS CUI [3,1]
C0935929
UMLS CUI [3,2]
C1517586
UMLS CUI [3,3]
C0166418
body mass index >45 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
fasting triglycerides >500 mg/dl
Description

Serum fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0582824
uncontrolled hypertension (sitting systolic blood pressure >160 mmhg and/or sitting diastolic blood pressure >100 mmhg
Description

Uncontrolled hypertension | Sitting systolic blood pressure | Sitting diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C1319893
UMLS CUI [3]
C1319894
presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
Description

Complications of Diabetes Mellitus Complicating Study Subject Participation Status | Patient need for Medication New

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C1522701
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0205314
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00631007

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Sulfonylureas Dose Stable | Metformin Dose Stable | Combined Modality Therapy
Item
diagnosis of type 2 diabetes and on either sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy for at least 3 months at stable dose
boolean
C0011860 (UMLS CUI [1])
C0038766 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0009429 (UMLS CUI [4])
Age | Female infertility | Gender Barrier Contraception Double
Item
males and females (of non-childbearing potential or who are using dual barrier methods of contraception) between 30 and 75 years of age
boolean
C0001779 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
Hemoglobin A1c measurement
Item
hba1c must be ≥7.5% and ≤10% at screening
boolean
C0474680 (UMLS CUI [1])
Plasma fasting glucose measurement
Item
fasting plasma glucose must be <240 mg/dl at screening
boolean
C0583513 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
history of type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Diabetic Ketoacidosis
Item
history of diabetic ketoacidosis
boolean
C0011880 (UMLS CUI [1])
Cardiac Status New York Heart Association Classification | Hospitalization Due to Congestive heart failure
Item
nyha class iii or iv cardiac status or hospitalization for congestive heart failure within 6 weeks prior to visit 1
boolean
C1999091 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0018802 (UMLS CUI [2,3])
Antidiabetics Investigational | Antidiabetics Approved | Exception Peroxisome Proliferator-Activated Receptors | Exception Metformin | Exception Sulfonylureas
Item
treatment with any non-peroxisome proliferator-activated receptor (non-ppar) antidiabetic agent, investigational or approved, other than metformin or permitted sulfonylureas within 3 months prior to screening
boolean
C0935929 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0935929 (UMLS CUI [2,1])
C0205540 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0166418 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0025598 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0038766 (UMLS CUI [5,2])
rosiglitazone | pioglitazone | Antidiabetics Investigational PPAR
Item
treatment with rosiglitazone, pioglitazone, or any ppar investigational antidiabetic agent within 6 month prior to screening
boolean
C0289313 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
C0935929 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0166418 (UMLS CUI [3,3])
Body mass index
Item
body mass index >45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Serum fasting triglyceride measurement
Item
fasting triglycerides >500 mg/dl
boolean
C0582824 (UMLS CUI [1])
Uncontrolled hypertension | Sitting systolic blood pressure | Sitting diastolic blood pressure
Item
uncontrolled hypertension (sitting systolic blood pressure >160 mmhg and/or sitting diastolic blood pressure >100 mmhg
boolean
C1868885 (UMLS CUI [1])
C1319893 (UMLS CUI [2])
C1319894 (UMLS CUI [3])
Complications of Diabetes Mellitus Complicating Study Subject Participation Status | Patient need for Medication New
Item
presence of diabetic complications, which in the opinion of the investigator, would complicate the subject's participation in the study (i.e., require initiation of new medication)
boolean
C0342257 (UMLS CUI [1,1])
C1522701 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])
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