ID

19413

Description

Effects of Insulin in Perceived Mood Symptoms in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00191178

Link

https://clinicaltrials.gov/show/NCT00191178

Keywords

Versions (1)
  1. 12/30/16 12/30/16 -
Uploaded on

December 30, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00191178

English

Eligibility Type 2 Diabetes NCT00191178

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosed as having type 2 diabetes mellitus, as defined by the world health organization
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
are being treated with metformin therapy alone, metformin therapy plus once-daily insulin, or metformin plus one or more other oral antihyperglycemic agents at the time of study entry
Description

Metformin | Insulin Once daily | Hypoglycemic Agents Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C0556983
UMLS CUI [3,1]
C0020616
UMLS CUI [3,2]
C1265611
female patients not breastfeeding and female patients of childbearing potential must test negative for pregnancy at time of study entry based on a urine pregnancy test and do not intend to become pregnant during the study and agree to use a reliable form of birth control during the study
Description

Breast Feeding Urine pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Planned Pregnancy Unwilling | Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0006147
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
UMLS CUI [3,1]
C0032992
UMLS CUI [3,2]
C0558080
UMLS CUI [4]
C0700589
hemoglobin a1c greater than or equal to 7.0% and less than or equal to 10% within 3 months prior to visit 1
Description

Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202054
have given informed consent to participate in the study in accordance with local regulations
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
Description

Research Personnel Affiliated Clinical Trial | Research Personnel Family Affiliated Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0035173
UMLS CUI [1,2]
C1510826
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0035173
UMLS CUI [2,2]
C0015576
UMLS CUI [2,3]
C1510826
UMLS CUI [2,4]
C0008976
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
Description

Drugs, Non-Prescription

Data type

boolean

Alias
UMLS CUI [1]
C0013231
have previously been diagnosed with clinical depression or have been treated with a central nervous system stimulant, antidepressant, antipsychotic, or anxiolytic agent within 30 days prior to study entry
Description

clinical depression | Central Nervous System Stimulants | Antidepressive Agents | Antipsychotic Agents | Anti-Anxiety Agents

Data type

boolean

Alias
UMLS CUI [1]
C2362914
UMLS CUI [2]
C0002763
UMLS CUI [3]
C0003289
UMLS CUI [4]
C0040615
UMLS CUI [5]
C0040616
have a known allergy to insulin lispro low mixture, insulin glargine, metformin hydrochloride, or excipients contained in these products
Description

Hypersensitivity Insulin Lispro Mixture Low | Hypersensitivity Insulin Glargine | Hypersensitivity Metformin hydrochloride | Hypersensitivity Excipients

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0293359
UMLS CUI [1,3]
C0439962
UMLS CUI [1,4]
C0445550
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0907402
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0770893
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0015237
have known hypersensitivity or contraindication to metformin hydrochloride
Description

Hypersensitivity Metformin hydrochloride | Medical contraindication Metformin hydrochloride

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0770893
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0770893
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Similar models

Eligibility Type 2 Diabetes NCT00191178

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosed as having type 2 diabetes mellitus, as defined by the world health organization
boolean
C0011860 (UMLS CUI [1])
Metformin | Insulin Once daily | Hypoglycemic Agents Quantity
Item
are being treated with metformin therapy alone, metformin therapy plus once-daily insulin, or metformin plus one or more other oral antihyperglycemic agents at the time of study entry
boolean
C0025598 (UMLS CUI [1])
C0021641 (UMLS CUI [2,1])
C0556983 (UMLS CUI [2,2])
C0020616 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Breast Feeding Urine pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Planned Pregnancy Unwilling | Contraceptive methods
Item
female patients not breastfeeding and female patients of childbearing potential must test negative for pregnancy at time of study entry based on a urine pregnancy test and do not intend to become pregnant during the study and agree to use a reliable form of birth control during the study
boolean
C0006147 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4])
Glucohemoglobin measurement
Item
hemoglobin a1c greater than or equal to 7.0% and less than or equal to 10% within 3 months prior to visit 1
boolean
C0202054 (UMLS CUI [1])
Informed Consent
Item
have given informed consent to participate in the study in accordance with local regulations
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Research Personnel Affiliated Clinical Trial | Research Personnel Family Affiliated Clinical Trial
Item
are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
boolean
C0035173 (UMLS CUI [1,1])
C1510826 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0035173 (UMLS CUI [2,1])
C0015576 (UMLS CUI [2,2])
C1510826 (UMLS CUI [2,3])
C0008976 (UMLS CUI [2,4])
Drugs, Non-Prescription
Item
have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
boolean
C0013231 (UMLS CUI [1])
clinical depression | Central Nervous System Stimulants | Antidepressive Agents | Antipsychotic Agents | Anti-Anxiety Agents
Item
have previously been diagnosed with clinical depression or have been treated with a central nervous system stimulant, antidepressant, antipsychotic, or anxiolytic agent within 30 days prior to study entry
boolean
C2362914 (UMLS CUI [1])
C0002763 (UMLS CUI [2])
C0003289 (UMLS CUI [3])
C0040615 (UMLS CUI [4])
C0040616 (UMLS CUI [5])
Hypersensitivity Insulin Lispro Mixture Low | Hypersensitivity Insulin Glargine | Hypersensitivity Metformin hydrochloride | Hypersensitivity Excipients
Item
have a known allergy to insulin lispro low mixture, insulin glargine, metformin hydrochloride, or excipients contained in these products
boolean
C0020517 (UMLS CUI [1,1])
C0293359 (UMLS CUI [1,2])
C0439962 (UMLS CUI [1,3])
C0445550 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0907402 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0770893 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
Hypersensitivity Metformin hydrochloride | Medical contraindication Metformin hydrochloride
Item
have known hypersensitivity or contraindication to metformin hydrochloride
boolean
C0020517 (UMLS CUI [1,1])
C0770893 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0770893 (UMLS CUI [2,2])
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