ID

17259

Description

Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00332488

Link

https://clinicaltrials.gov/show/NCT00332488

Keywords

Versions (1)
  1. 9/2/16 9/2/16 -
Uploaded on

September 2, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00332488

English

Eligibility Diabetes Mellitus, Type 2 NCT00332488

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-smokers with clinical diagnosis of type 2 diabetes mellitus for >or= to 6 months
Description

Non-smoker | Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0011860
stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
Description

Metformin Stable status Quantity per day | Metformin Stable status Maximum Tolerated Dose | Pills Insulin Releasing

Data type

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
UMLS CUI [2,1]
C0025598
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0752079
UMLS CUI [3,1]
C0994475
UMLS CUI [3,2]
C0021641
UMLS CUI [3,3]
C1283071
fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
Description

Metformin | Sulfonylurea | Combination Product Acceptable

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
UMLS CUI [3,1]
C1880146
UMLS CUI [3,2]
C1879533
hba1c >or= to 7.5% and < or= to 11.0%
Description

Glycosylated hemoglobin A

Data type

boolean

Alias
UMLS CUI [1]
C0019018
bmi < or = to 40kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
fev1> or = to 70%, total lung capacity and > or =80% dlco > or= to 70%
Description

FEV1 | Total Lung Capacity | DLCO

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C0040509
UMLS CUI [3]
C1516251
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment with any type of anti-diabetic therapy, other than metformin &
Description

Antidiabetics | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C0025598
secretagogues within the preceding 12 weeks
Description

Pills Insulin Releasing

Data type

boolean

Alias
UMLS CUI [1,1]
C0994475
UMLS CUI [1,2]
C0021641
UMLS CUI [1,3]
C1283071
serum creatinine > 1.4mg/dl in female subjects and >1.5mg/dl in male subjects
Description

Creatinine measurement, serum | Gender

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
history of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
Description

Chronic Obstructive Airway Disease | Asthma | Pulmonary function tests Clinical Significance | Radiologic finding Clinical Significance

Data type

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0004096
UMLS CUI [3,1]
C0024119
UMLS CUI [3,2]
C2826293
UMLS CUI [4,1]
C1290916
UMLS CUI [4,2]
C2826293
evidence of serious complications of diabetes (e.g. autonomic neuropathy)
Description

Complications of Diabetes Mellitus Serious Evidence of | Autonomic neuropathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0342257
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332120
UMLS CUI [2]
C0259749
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00332488

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-smoker | Diabetes Mellitus, Non-Insulin-Dependent
Item
non-smokers with clinical diagnosis of type 2 diabetes mellitus for >or= to 6 months
boolean
C0337672 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Metformin Stable status Quantity per day | Metformin Stable status Maximum Tolerated Dose | Pills Insulin Releasing
Item
stable regimen of metformin for > or = to 1000mg/day or maximum tolerated dose) and a secretagogue < or = 1/2 the maximum manufacturer-recommended daily dose without any dose adjustments within the preceding 6 wks.
boolean
C0025598 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C0025598 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0752079 (UMLS CUI [2,3])
C0994475 (UMLS CUI [3,1])
C0021641 (UMLS CUI [3,2])
C1283071 (UMLS CUI [3,3])
Metformin | Sulfonylurea | Combination Product Acceptable
Item
fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1880146 (UMLS CUI [3,1])
C1879533 (UMLS CUI [3,2])
Glycosylated hemoglobin A
Item
hba1c >or= to 7.5% and < or= to 11.0%
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
bmi < or = to 40kg/m2.
boolean
C1305855 (UMLS CUI [1])
FEV1 | Total Lung Capacity | DLCO
Item
fev1> or = to 70%, total lung capacity and > or =80% dlco > or= to 70%
boolean
C0748133 (UMLS CUI [1])
C0040509 (UMLS CUI [2])
C1516251 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Antidiabetics | Metformin
Item
treatment with any type of anti-diabetic therapy, other than metformin &
boolean
C0935929 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Pills Insulin Releasing
Item
secretagogues within the preceding 12 weeks
boolean
C0994475 (UMLS CUI [1,1])
C0021641 (UMLS CUI [1,2])
C1283071 (UMLS CUI [1,3])
Creatinine measurement, serum | Gender
Item
serum creatinine > 1.4mg/dl in female subjects and >1.5mg/dl in male subjects
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Chronic Obstructive Airway Disease | Asthma | Pulmonary function tests Clinical Significance | Radiologic finding Clinical Significance
Item
history of chronic obstructive pulmonary disease, clinically proven asthma and/or any other clinically important pulmonary function testing and/or radiologic findings
boolean
C0024117 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0024119 (UMLS CUI [3,1])
C2826293 (UMLS CUI [3,2])
C1290916 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
Complications of Diabetes Mellitus Serious Evidence of | Autonomic neuropathy
Item
evidence of serious complications of diabetes (e.g. autonomic neuropathy)
boolean
C0342257 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C0259749 (UMLS CUI [2])
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