ID

24008

Beschrijving

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY); ODM derived from: https://clinicaltrials.gov/show/NCT00494013

Link

https://clinicaltrials.gov/show/NCT00494013

Trefwoorden

Versies (1)
  1. 21-07-17 21-07-17 -
Geüploaded op

21 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT00494013

Engels

Eligibility Diabetes Mellitus Type 2 NCT00494013

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. have type 2 diabetes mellitus for at least 1 year.
Beschrijving

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
2. are at least 18 years old.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1, at or above the doses defined in the following: metformin--1500 milligrams per day (mg/day); sulfonylureas--1/2 the maximum daily dose, according to the local package insert; dipeptidyl peptidase-intravenous (dpp-iv) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; thiazolidinediones (tzds)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
Beschrijving

Hypoglycemic Agents Oral | Insulin Excluded | Metformin | Sulfonylurea | Dipeptidyl-Peptidase IV Inhibitors | Thiazolidinediones | pioglitazone | rosiglitazone

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020616
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0021641
UMLS CUI [2,2]
C2828389
UMLS CUI [3]
C0025598
UMLS CUI [4]
C0038766
UMLS CUI [5]
C1827106
UMLS CUI [6]
C1257987
UMLS CUI [7]
C0071097
UMLS CUI [8]
C0289313
4. have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2.
Beschrijving

Glycosylated hemoglobin A

Datatype

boolean

Alias
UMLS CUI [1]
C0019018
5. body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
Beschrijving

Insulin regime

Datatype

boolean

Alias
UMLS CUI [1]
C0557978
2. have taken any glucose-lowering medications not included in inclusion criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1.
Beschrijving

Hypoglycemic Agents | Acarbose | miglitol | Pramlintide | exenatide | repaglinide | nateglinide

Datatype

boolean

Alias
UMLS CUI [1]
C0020616
UMLS CUI [2]
C0050393
UMLS CUI [3]
C0066535
UMLS CUI [4]
C0537551
UMLS CUI [5]
C0167117
UMLS CUI [6]
C0246689
UMLS CUI [7]
C0903898
3. have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
Beschrijving

Hypoglycemia Severe Episode Quantity | Loss of hypoglycemic warning

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332189
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0342317
4. have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dl) (177 micromoles per liter [micromol/l]).
Beschrijving

Kidney Transplantation | Renal dialysis | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0011946
UMLS CUI [3]
C0201976
5. have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [alt], or aspartate transaminase [ast] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
Beschrijving

Liver disease Sign or Symptom | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum albumin abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C3540840
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0857878
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Similar models

Eligibility Diabetes Mellitus Type 2 NCT00494013

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
1. have type 2 diabetes mellitus for at least 1 year.
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
2. are at least 18 years old.
boolean
C0001779 (UMLS CUI [1])
Hypoglycemic Agents Oral | Insulin Excluded | Metformin | Sulfonylurea | Dipeptidyl-Peptidase IV Inhibitors | Thiazolidinediones | pioglitazone | rosiglitazone
Item
3. have been receiving oral antihyperglycemic medications (oams), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the following oams for the 6 weeks prior to visit 1, at or above the doses defined in the following: metformin--1500 milligrams per day (mg/day); sulfonylureas--1/2 the maximum daily dose, according to the local package insert; dipeptidyl peptidase-intravenous (dpp-iv) inhibitors-- 1/2 the maximum daily dose, according to the local package insert; thiazolidinediones (tzds)--30 mg/day pioglitazone or 4 mg/day rosiglitazone.
boolean
C0020616 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0021641 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0025598 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C1827106 (UMLS CUI [5])
C1257987 (UMLS CUI [6])
C0071097 (UMLS CUI [7])
C0289313 (UMLS CUI [8])
Glycosylated hemoglobin A
Item
4. have a hemoglobin a1c (hba1c) greater than or equal to 7.5% and less than or equal to 10.0%, as measured by a central laboratory before visit 2.
boolean
C0019018 (UMLS CUI [1])
Body mass index
Item
5. body mass index (bmi) greater than or equal to 25 and less than or equal to 45 kilograms per square meter (kg/m2).
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Insulin regime
Item
1. have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks.
boolean
C0557978 (UMLS CUI [1])
Hypoglycemic Agents | Acarbose | miglitol | Pramlintide | exenatide | repaglinide | nateglinide
Item
2. have taken any glucose-lowering medications not included in inclusion criterion [3] (for example, acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide) in the past 3 months before visit 1.
boolean
C0020616 (UMLS CUI [1])
C0050393 (UMLS CUI [2])
C0066535 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C0246689 (UMLS CUI [6])
C0903898 (UMLS CUI [7])
Hypoglycemia Severe Episode Quantity | Loss of hypoglycemic warning
Item
3. have had more than 1 episode of severe hypoglycemia, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332189 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0342317 (UMLS CUI [2])
Kidney Transplantation | Renal dialysis | Creatinine measurement, serum
Item
4. have a history of renal transplantation or are currently receiving renal dialysis or creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dl) (177 micromoles per liter [micromol/l]).
boolean
C0022671 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Liver disease Sign or Symptom | Alanine aminotransferase increased | Aspartate aminotransferase increased | Serum albumin abnormal
Item
5. have obvious clinical signs or symptoms, or laboratory evidence, of liver disease (alanine transaminase [alt], or aspartate transaminase [ast] greater than 2 times the upper limit of the reference range, as defined by the local laboratory) or have albumin value above or below the normal reference range, as defined by the local laboratory.
boolean
C0023895 (UMLS CUI [1,1])
C3540840 (UMLS CUI [1,2])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0857878 (UMLS CUI [4])
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