ID

29107

Description

Multiple Dose Escalation Trial Of PF-04603629 Given To Subjects With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00637338

Link

https://clinicaltrials.gov/show/NCT00637338

Keywords

Versions (1)
  1. 2/25/18 2/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 25, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00637338

English

Eligibility Diabetes Mellitus, Type 2 NCT00637338

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with type 2 diabetes mellitus who are not taking any treatment or are taking metformin (with no change in the treatment, including dose, over the past 2 months). subjects previously treated with a sulfonylurea in combination with metformin may be eligible if switched over to metformin only for a minimum of 4 weeks before dosing.
Description

Diabetes Mellitus, Non-Insulin-Dependent | Therapeutic procedure Absent | Metformin Dose unchanged | Sulfonylurea

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0442739
UMLS CUI [4]
C0038766
male and/or female subjects (females will be women of non-childbearing potential) between the ages of 18 and 70 years, inclusive.
Description

Age | Gender Childbearing Potential Absent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0332197
body mass index (bmi) of approximately 22 to 40 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
fasting c-peptide test result must be >0.4 nmol/l.
Description

Fasting C-peptide level

Data type

boolean

Alias
UMLS CUI [1]
C2208720
hba1c ≥7% and ≤11%. if the subject requires to be washed off a sulfonylurea, the hba1c limits will be ≥7% and ≤9.5%.
Description

Glucohemoglobin measurement | Relationship Sulfonylurea Washout

Data type

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0038766
UMLS CUI [2,3]
C1710661
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
screening fasting blood glucose, ≤60 or ≥270 mg/dl. one repeat screening fasting blood glucose will be allowed.
Description

Fasting blood glucose measurement | Fasting blood glucose measurement Repeat Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0428568
UMLS CUI [2,1]
C0428568
UMLS CUI [2,2]
C0205341
UMLS CUI [2,3]
C1265611
previous treatment with an approved or investigational glp-1 mimetic.
Description

GLP-1 Mimetics Approved | GLP-1 Mimetics Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C3273809
UMLS CUI [1,2]
C0205540
UMLS CUI [2,1]
C3273809
UMLS CUI [2,2]
C1517586
have a known allergy to yeast, yeast-derived or yeast containing products.
Description

Allergy to yeast | Hypersensitivity Product Yeast Derived | Hypersensitivity Product Containing Yeast

Data type

boolean

Alias
UMLS CUI [1]
C3875439
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1514468
UMLS CUI [2,3]
C0036025
UMLS CUI [2,4]
C1441547
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1514468
UMLS CUI [3,3]
C0332256
UMLS CUI [3,4]
C0036025
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00637338

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Therapeutic procedure Absent | Metformin Dose unchanged | Sulfonylurea
Item
patients with type 2 diabetes mellitus who are not taking any treatment or are taking metformin (with no change in the treatment, including dose, over the past 2 months). subjects previously treated with a sulfonylurea in combination with metformin may be eligible if switched over to metformin only for a minimum of 4 weeks before dosing.
boolean
C0011860 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
C0038766 (UMLS CUI [4])
Age | Gender Childbearing Potential Absent
Item
male and/or female subjects (females will be women of non-childbearing potential) between the ages of 18 and 70 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Body mass index
Item
body mass index (bmi) of approximately 22 to 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Fasting C-peptide level
Item
fasting c-peptide test result must be >0.4 nmol/l.
boolean
C2208720 (UMLS CUI [1])
Glucohemoglobin measurement | Relationship Sulfonylurea Washout
Item
hba1c ≥7% and ≤11%. if the subject requires to be washed off a sulfonylurea, the hba1c limits will be ≥7% and ≤9.5%.
boolean
C0202054 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C0038766 (UMLS CUI [2,2])
C1710661 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Fasting blood glucose measurement | Fasting blood glucose measurement Repeat Quantity
Item
screening fasting blood glucose, ≤60 or ≥270 mg/dl. one repeat screening fasting blood glucose will be allowed.
boolean
C0428568 (UMLS CUI [1])
C0428568 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
GLP-1 Mimetics Approved | GLP-1 Mimetics Investigational
Item
previous treatment with an approved or investigational glp-1 mimetic.
boolean
C3273809 (UMLS CUI [1,1])
C0205540 (UMLS CUI [1,2])
C3273809 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
Allergy to yeast | Hypersensitivity Product Yeast Derived | Hypersensitivity Product Containing Yeast
Item
have a known allergy to yeast, yeast-derived or yeast containing products.
boolean
C3875439 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C1514468 (UMLS CUI [2,2])
C0036025 (UMLS CUI [2,3])
C1441547 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C1514468 (UMLS CUI [3,2])
C0332256 (UMLS CUI [3,3])
C0036025 (UMLS CUI [3,4])
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