ID

43956

Beskrivning

Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00191464

Länk

https://clinicaltrials.gov/show/NCT00191464

Nyckelord

Versioner (2)
  1. 2016-09-01 2016-09-01 -
  2. 2021-09-20 2021-09-20 -
Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00191464

Engelsk

Eligibility Diabetes Mellitus, Type 2 NCT00191464

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have type 2 diabetes (world health organization [who] classification
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
have used one or more of the following oral anti-hyperglycemic medications-metformin or second-generation sulfonylurea (for example, glibenclamide, glyburide, glipizide, gliclazide, glimepiride) alone or in combination with one or two insulin injections per day for at least 3 months immediately prior to entering the study. patients using more than 2 insulin injections per day or subcutaneous insulin infusion prior to the study will not be eligible to participate.
Beskrivning

Oral hypoglycemic | Metformin | Second generation sulfonylurea | Glyburide | Glipizide | Gliclazide | glimepiride | Administration of insulin Quantity per day | Subcutaneous injection of insulin

Datatyp

boolean

Alias
UMLS CUI [1]
C0359086
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1300198
UMLS CUI [4]
C0017628
UMLS CUI [5]
C0017642
UMLS CUI [6]
C0017631
UMLS CUI [7]
C0061323
UMLS CUI [8,1]
C0199782
UMLS CUI [8,2]
C1265611
UMLS CUI [8,3]
C0439505
UMLS CUI [9]
C0586328
have a hemoglobin a1c between 6.5% and 11%, inclusive, according to the central laboratory at visit 1.
Beskrivning

Glycosylated hemoglobin A

Datatyp

boolean

Alias
UMLS CUI [1]
C0019018
have clinically acceptable ldl-c, in the investigator's opinion, at visit 1.
Beskrivning

Low density lipoprotein cholesterol measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202117
as determined by the investigator, are capable and willing to learn how to use the insulin injection pens; comply with their prescribed diet, exercise, and medication regimen; perform self-monitoring of blood glucose; and use the patient diary as required for this protocol.
Beskrivning

Insulin Injection pen Use Willing | Compliance with prescribed diet | Exercise Compliance | Medication regimen Compliance | Blood Glucose Self-Monitoring | Subject Diary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C3273588
UMLS CUI [1,3]
C1524063
UMLS CUI [1,4]
C0600109
UMLS CUI [2]
C4039442
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C3714738
UMLS CUI [4,1]
C0237125
UMLS CUI [4,2]
C3714738
UMLS CUI [5]
C0005803
UMLS CUI [6]
C3890583
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have hypersensitivity to metformin or a known allergy to metformin hydrochloride, insulin lispro mm, insulin lispro lm, or insulin glargine, or excipients contained in these products.
Beskrivning

Hypersensitivity Metformin | Hypersensitivity Metformin hydrochloride | Hypersensitivity Insulin Lispro | Hypersensitivity Insulin Glargine | Hypersensitivity Excipients Substances named

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0025598
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0770893
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0293359
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0907402
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0015237
UMLS CUI [5,3]
C0439861
UMLS CUI [5,4]
C0027365
have known metabolic or lactic acidosis.
Beskrivning

Metabolic acidosis | Acidosis, Lactic

Datatyp

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0001125
have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than or equal to 135 micromol/l (1.5 mg/dl) for males and greater than or equal to 110 micromol/l (1.2 mg/dl) for females.
Beskrivning

Kidney Transplantation | Dialysis procedure | Creatinine measurement, serum | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399
have cardiac disease with functional status that is class iii or iv
Beskrivning

Heart Diseases | New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C1275491
have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine transaminase (alt) greater than three times the upper limit of the reference range as defined by the central laboratory.
Beskrivning

Liver disease Sign or Symptom | Acute hepatitis | Hepatitis, Chronic | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C3540840
UMLS CUI [2]
C0267797
UMLS CUI [3]
C0019189
UMLS CUI [4]
C0201836
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT00191464

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
have type 2 diabetes (world health organization [who] classification
boolean
C0011860 (UMLS CUI [1])
Oral hypoglycemic | Metformin | Second generation sulfonylurea | Glyburide | Glipizide | Gliclazide | glimepiride | Administration of insulin Quantity per day | Subcutaneous injection of insulin
Item
have used one or more of the following oral anti-hyperglycemic medications-metformin or second-generation sulfonylurea (for example, glibenclamide, glyburide, glipizide, gliclazide, glimepiride) alone or in combination with one or two insulin injections per day for at least 3 months immediately prior to entering the study. patients using more than 2 insulin injections per day or subcutaneous insulin infusion prior to the study will not be eligible to participate.
boolean
C0359086 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1300198 (UMLS CUI [3])
C0017628 (UMLS CUI [4])
C0017642 (UMLS CUI [5])
C0017631 (UMLS CUI [6])
C0061323 (UMLS CUI [7])
C0199782 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C0439505 (UMLS CUI [8,3])
C0586328 (UMLS CUI [9])
Glycosylated hemoglobin A
Item
have a hemoglobin a1c between 6.5% and 11%, inclusive, according to the central laboratory at visit 1.
boolean
C0019018 (UMLS CUI [1])
Low density lipoprotein cholesterol measurement
Item
have clinically acceptable ldl-c, in the investigator's opinion, at visit 1.
boolean
C0202117 (UMLS CUI [1])
Insulin Injection pen Use Willing | Compliance with prescribed diet | Exercise Compliance | Medication regimen Compliance | Blood Glucose Self-Monitoring | Subject Diary
Item
as determined by the investigator, are capable and willing to learn how to use the insulin injection pens; comply with their prescribed diet, exercise, and medication regimen; perform self-monitoring of blood glucose; and use the patient diary as required for this protocol.
boolean
C0021641 (UMLS CUI [1,1])
C3273588 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,3])
C0600109 (UMLS CUI [1,4])
C4039442 (UMLS CUI [2])
C0015259 (UMLS CUI [3,1])
C3714738 (UMLS CUI [3,2])
C0237125 (UMLS CUI [4,1])
C3714738 (UMLS CUI [4,2])
C0005803 (UMLS CUI [5])
C3890583 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Metformin | Hypersensitivity Metformin hydrochloride | Hypersensitivity Insulin Lispro | Hypersensitivity Insulin Glargine | Hypersensitivity Excipients Substances named
Item
have hypersensitivity to metformin or a known allergy to metformin hydrochloride, insulin lispro mm, insulin lispro lm, or insulin glargine, or excipients contained in these products.
boolean
C0020517 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0770893 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0293359 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0907402 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0015237 (UMLS CUI [5,2])
C0439861 (UMLS CUI [5,3])
C0027365 (UMLS CUI [5,4])
Metabolic acidosis | Acidosis, Lactic
Item
have known metabolic or lactic acidosis.
boolean
C0220981 (UMLS CUI [1])
C0001125 (UMLS CUI [2])
Kidney Transplantation | Dialysis procedure | Creatinine measurement, serum | Gender
Item
have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than or equal to 135 micromol/l (1.5 mg/dl) for males and greater than or equal to 110 micromol/l (1.2 mg/dl) for females.
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
Heart Diseases | New York Heart Association Classification
Item
have cardiac disease with functional status that is class iii or iv
boolean
C0018799 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Liver disease Sign or Symptom | Acute hepatitis | Hepatitis, Chronic | Alanine aminotransferase measurement
Item
have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine transaminase (alt) greater than three times the upper limit of the reference range as defined by the central laboratory.
boolean
C0023895 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
C0019189 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
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