ID

29111

Beskrivning

A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00642538

Länk

https://clinicaltrials.gov/show/NCT00642538

Nyckelord

Versioner (1)
  1. 2018-02-26 2018-02-26 -
Rättsinnehavare

See clinicaltrials.gov

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26 februari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00642538

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00642538

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-smoking males and females between 18 and 70 years of age
Beskrivning

Non-smoker | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2]
C0001779
body mass index (bmi) of < 32 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, without any dose adjustments within the preceding 8 weeks. for subjects taking both metformin and sulfonylurea or meglitinide or alpha glucosidase inhibitor, one or both oral agents must be less than 1/2 the maximal allowable dose as cited in the product label.
Beskrivning

Diabetes mellitus management | Diet therapy Stable | Exercise Stable | Metformin | Sulfonylurea | Meglitinide | alpha-Glucosidase Inhibitors | Dose Adjustment Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0948092
UMLS CUI [2,1]
C0012159
UMLS CUI [2,2]
C0205360
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C0205360
UMLS CUI [4]
C0025598
UMLS CUI [5]
C0038766
UMLS CUI [6]
C0065880
UMLS CUI [7]
C1299007
UMLS CUI [8,1]
C2826232
UMLS CUI [8,2]
C0332197
hba1c = 6.2 to = 8.5%. fasting c-peptide = 0.5 ng/ml. on the last 3 days of the washout period (day -3, -2, and -1) subjects should have a fbg (finger stick) = 13.5 mmol/l.
Beskrivning

Glucohemoglobin measurement | Fasting C-peptide level | Fasting blood glucose measurement Washout Period Fingerstick

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2]
C2208720
UMLS CUI [3,1]
C0428568
UMLS CUI [3,2]
C1710661
UMLS CUI [3,3]
C2022094
normal pulmonary function and performance on pulmonary function tests
Beskrivning

Pulmonary function | Pulmonary function tests

Datatyp

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2]
C0024119
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
treatment with any type of anti-diabetic therapy other than metformin, sulfonylurea, meglitinide and alpha glucosidase inhibitors within the preceding 12 weeks [ie, thiazolidinediones (tzds), dipeptyl peptidase inhibitors (dpp-iv), symlin (pramlintide acetate) and or byetta (exenatide)].
Beskrivning

Antidiabetics | Exception Metformin | Exception Sulfonylurea | Exception Meglitinide | Exception alpha-Glucosidase Inhibitors | Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors | Symlin | pramlintide acetate | Byetta | exenatide

Datatyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0038766
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0065880
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1299007
UMLS CUI [6]
C1257987
UMLS CUI [7]
C1827106
UMLS CUI [8]
C1174780
UMLS CUI [9]
C1174779
UMLS CUI [10]
C1636686
UMLS CUI [11]
C0167117
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
exposure to any investigational medications or devices within the previous 90 days prior to trial entry or participation in another clinical trial while participating in this trial.
Beskrivning

Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C2346570
UMLS CUI [3]
C2348568
use of any prescription medication within 90 days prior to screening, other than allowed anti-diabetic therapy, that has not been approved by the pi and sponsor. the use of alpha blockers, antihypertensives, proton pump inhibitors and cholesterol medication as co-medications is allowed throughout the study.
Beskrivning

Prescription Drugs | Exception Antidiabetics | Adrenergic alpha-Antagonists allowed | Antihypertensive Agents allowed | Proton Pump Inhibitors allowed | Cholesterol lowering drugs allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0935929
UMLS CUI [3,1]
C0001641
UMLS CUI [3,2]
C0683607
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0683607
UMLS CUI [5,1]
C0358591
UMLS CUI [5,2]
C0683607
UMLS CUI [6,1]
C0003277
UMLS CUI [6,2]
C0683607
significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of 12% and 200 ml in either fvc or fev1).
Beskrivning

Improvement Spirometry, before and after bronchodilator | FVC Increase | FEV1 Increase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0545456
UMLS CUI [2,1]
C3714541
UMLS CUI [2,2]
C0442805
UMLS CUI [3,1]
C0849974
UMLS CUI [3,2]
C0442805
serum creatinine above upper limit of normal (uln) as defined by the laboratory
Beskrivning

Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C0700225
any other condition which, in the opinion of the pi, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial.
Beskrivning

Condition Study Subject Participation Status Inappropriate | Condition Validity Informed Consent Limited | Condition Study Subject Participation Status Impaired

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2349101
UMLS CUI [2,3]
C0021430
UMLS CUI [2,4]
C0439801
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0221099
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00642538

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-smoker | Age
Item
non-smoking males and females between 18 and 70 years of age
boolean
C0337672 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
body mass index (bmi) of < 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes mellitus management | Diet therapy Stable | Exercise Stable | Metformin | Sulfonylurea | Meglitinide | alpha-Glucosidase Inhibitors | Dose Adjustment Absent
Item
diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, without any dose adjustments within the preceding 8 weeks. for subjects taking both metformin and sulfonylurea or meglitinide or alpha glucosidase inhibitor, one or both oral agents must be less than 1/2 the maximal allowable dose as cited in the product label.
boolean
C0948092 (UMLS CUI [1])
C0012159 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4])
C0038766 (UMLS CUI [5])
C0065880 (UMLS CUI [6])
C1299007 (UMLS CUI [7])
C2826232 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
Glucohemoglobin measurement | Fasting C-peptide level | Fasting blood glucose measurement Washout Period Fingerstick
Item
hba1c = 6.2 to = 8.5%. fasting c-peptide = 0.5 ng/ml. on the last 3 days of the washout period (day -3, -2, and -1) subjects should have a fbg (finger stick) = 13.5 mmol/l.
boolean
C0202054 (UMLS CUI [1])
C2208720 (UMLS CUI [2])
C0428568 (UMLS CUI [3,1])
C1710661 (UMLS CUI [3,2])
C2022094 (UMLS CUI [3,3])
Pulmonary function | Pulmonary function tests
Item
normal pulmonary function and performance on pulmonary function tests
boolean
C0231921 (UMLS CUI [1])
C0024119 (UMLS CUI [2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Antidiabetics | Exception Metformin | Exception Sulfonylurea | Exception Meglitinide | Exception alpha-Glucosidase Inhibitors | Thiazolidinediones | Dipeptidyl-Peptidase IV Inhibitors | Symlin | pramlintide acetate | Byetta | exenatide
Item
treatment with any type of anti-diabetic therapy other than metformin, sulfonylurea, meglitinide and alpha glucosidase inhibitors within the preceding 12 weeks [ie, thiazolidinediones (tzds), dipeptyl peptidase inhibitors (dpp-iv), symlin (pramlintide acetate) and or byetta (exenatide)].
boolean
C0935929 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0065880 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C1299007 (UMLS CUI [5,2])
C1257987 (UMLS CUI [6])
C1827106 (UMLS CUI [7])
C1174780 (UMLS CUI [8])
C1174779 (UMLS CUI [9])
C1636686 (UMLS CUI [10])
C0167117 (UMLS CUI [11])
Item Group
C0680251 (UMLS CUI)
Exposure to Investigational New Drugs | Exposure to Investigational Medical Device | Study Subject Participation Status
Item
exposure to any investigational medications or devices within the previous 90 days prior to trial entry or participation in another clinical trial while participating in this trial.
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2346570 (UMLS CUI [2,2])
C2348568 (UMLS CUI [3])
Prescription Drugs | Exception Antidiabetics | Adrenergic alpha-Antagonists allowed | Antihypertensive Agents allowed | Proton Pump Inhibitors allowed | Cholesterol lowering drugs allowed
Item
use of any prescription medication within 90 days prior to screening, other than allowed anti-diabetic therapy, that has not been approved by the pi and sponsor. the use of alpha blockers, antihypertensives, proton pump inhibitors and cholesterol medication as co-medications is allowed throughout the study.
boolean
C0304227 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0935929 (UMLS CUI [2,2])
C0001641 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0358591 (UMLS CUI [5,1])
C0683607 (UMLS CUI [5,2])
C0003277 (UMLS CUI [6,1])
C0683607 (UMLS CUI [6,2])
Improvement Spirometry, before and after bronchodilator | FVC Increase | FEV1 Increase
Item
significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of 12% and 200 ml in either fvc or fev1).
boolean
C2986411 (UMLS CUI [1,1])
C0545456 (UMLS CUI [1,2])
C3714541 (UMLS CUI [2,1])
C0442805 (UMLS CUI [2,2])
C0849974 (UMLS CUI [3,1])
C0442805 (UMLS CUI [3,2])
Serum creatinine raised
Item
serum creatinine above upper limit of normal (uln) as defined by the laboratory
boolean
C0700225 (UMLS CUI [1])
Condition Study Subject Participation Status Inappropriate | Condition Validity Informed Consent Limited | Condition Study Subject Participation Status Impaired
Item
any other condition which, in the opinion of the pi, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2349101 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
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