ID

32811

Beschreibung

A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00757601

Link

https://clinicaltrials.gov/show/NCT00757601

Stichworte

Versionen (1)
  1. 15.11.18 15.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

15. November 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00757601

Englisch

Eligibility Type 2 Diabetes Mellitus NCT00757601

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant is between 18 and 55 years of age. participants up to 65 years of age may be enrolled in panels b and c
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
female participants must be postmenopausal or otherwise unable to have children
Beschreibung

Postmenopausal state | Female infertility

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0021361
participant has a body mass index (bmi) less than or equal to 42 kg/m^2 at the screening visit
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. for panels b and c, participant may be treated with combination oral anti-hyperglycemic medications
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Oral hypoglycemic Single | Oral hypoglycemic Combined Modality Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0012159
UMLS CUI [3]
C0015259
UMLS CUI [4,1]
C0359086
UMLS CUI [4,2]
C0205171
UMLS CUI [5,1]
C0359086
UMLS CUI [5,2]
C0009429
participant is willing to follow the american heart association (aha) diet and exercise program throughout the study
Beschreibung

Adherence Diet therapy American Heart Association | Adherence Exercise American Heart Association

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0012159
UMLS CUI [1,3]
C0002458
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C0015259
UMLS CUI [2,3]
C0002458
participant is a nonsmoker or has not used nicotine-containing products for 6 months prior to study start
Beschreibung

Non-smoker | Tobacco use Absent Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0449238
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
participant has a history of stroke, seizures, or other neurological disorders
Beschreibung

Cerebrovascular accident | Seizures | Nervous system disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0027765
participant has a recent history of eye infection or other inflammatory eye conditions
Beschreibung

Eye Infection | Inflammatory abnormality of the eye

Datentyp

boolean

Alias
UMLS CUI [1]
C0015403
UMLS CUI [2]
C4020969
participant has glaucoma or is blind
Beschreibung

Glaucoma | Blindness

Datentyp

boolean

Alias
UMLS CUI [1]
C0017601
UMLS CUI [2]
C0456909
participant has had eye surgery within 6 months of study start (lasik is permitted)
Beschreibung

Ophthalmologic Surgical Procedures | LASIK allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0038901
UMLS CUI [2,1]
C0752094
UMLS CUI [2,2]
C0683607
participant has type 1 diabetes
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
participant cannot stop taking any of their current prescription or non-prescription medications during the study
Beschreibung

Pharmaceutical Preparations Unable to discontinue | Non-Prescription Drugs Unable to discontinue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C1548265
participant consumes more than 3 alcoholic beverages per day
Beschreibung

Consumption Alcoholic Beverages U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
participant consumes more than 6 caffeinated beverages per day
Beschreibung

Consumption Caffeinated beverage U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0948365
UMLS CUI [1,2]
C0678438
UMLS CUI [1,3]
C0456683
participant has had major surgery or has donated blood within 4 weeks of study start
Beschreibung

Major surgery | Blood Donation

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0005794
participant has multiple and/or severe allergies to drugs or food
Beschreibung

DRUG ALLERGY MULTIPLE | Drug Allergy Severe | FOOD ALLERGY TO MULTIPLE FOOD | Food Allergy Severe

Datentyp

boolean

Alias
UMLS CUI [1]
C0743280
UMLS CUI [2,1]
C0013182
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0744084
UMLS CUI [4,1]
C0016470
UMLS CUI [4,2]
C0205082
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT00757601

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
participant is between 18 and 55 years of age. participants up to 65 years of age may be enrolled in panels b and c
boolean
C0001779 (UMLS CUI [1])
Postmenopausal state | Female infertility
Item
female participants must be postmenopausal or otherwise unable to have children
boolean
C0232970 (UMLS CUI [1])
C0021361 (UMLS CUI [2])
Body mass index
Item
participant has a body mass index (bmi) less than or equal to 42 kg/m^2 at the screening visit
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Oral hypoglycemic Single | Oral hypoglycemic Combined Modality Therapy
Item
participant has type 2 diabetes and is being treated with either diet and exercise or a single oral anti-hyperglycemic medication. for panels b and c, participant may be treated with combination oral anti-hyperglycemic medications
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0359086 (UMLS CUI [4,1])
C0205171 (UMLS CUI [4,2])
C0359086 (UMLS CUI [5,1])
C0009429 (UMLS CUI [5,2])
Adherence Diet therapy American Heart Association | Adherence Exercise American Heart Association
Item
participant is willing to follow the american heart association (aha) diet and exercise program throughout the study
boolean
C1510802 (UMLS CUI [1,1])
C0012159 (UMLS CUI [1,2])
C0002458 (UMLS CUI [1,3])
C1510802 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0002458 (UMLS CUI [2,3])
Non-smoker | Tobacco use Absent Duration
Item
participant is a nonsmoker or has not used nicotine-containing products for 6 months prior to study start
boolean
C0337672 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Seizures | Nervous system disorder
Item
participant has a history of stroke, seizures, or other neurological disorders
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
Eye Infection | Inflammatory abnormality of the eye
Item
participant has a recent history of eye infection or other inflammatory eye conditions
boolean
C0015403 (UMLS CUI [1])
C4020969 (UMLS CUI [2])
Glaucoma | Blindness
Item
participant has glaucoma or is blind
boolean
C0017601 (UMLS CUI [1])
C0456909 (UMLS CUI [2])
Ophthalmologic Surgical Procedures | LASIK allowed
Item
participant has had eye surgery within 6 months of study start (lasik is permitted)
boolean
C0038901 (UMLS CUI [1])
C0752094 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent
Item
participant has type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Pharmaceutical Preparations Unable to discontinue | Non-Prescription Drugs Unable to discontinue
Item
participant cannot stop taking any of their current prescription or non-prescription medications during the study
boolean
C0013227 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
Consumption Alcoholic Beverages U/day
Item
participant consumes more than 3 alcoholic beverages per day
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Consumption Caffeinated beverage U/day
Item
participant consumes more than 6 caffeinated beverages per day
boolean
C0948365 (UMLS CUI [1,1])
C0678438 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Major surgery | Blood Donation
Item
participant has had major surgery or has donated blood within 4 weeks of study start
boolean
C0679637 (UMLS CUI [1])
C0005794 (UMLS CUI [2])
DRUG ALLERGY MULTIPLE | Drug Allergy Severe | FOOD ALLERGY TO MULTIPLE FOOD | Food Allergy Severe
Item
participant has multiple and/or severe allergies to drugs or food
boolean
C0743280 (UMLS CUI [1])
C0013182 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0744084 (UMLS CUI [3])
C0016470 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
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