ID

43048

Description

ODM derived from http://clinicaltrials.gov/show/NCT01435616

Link

http://clinicaltrials.gov/show/NCT01435616

Keywords

Versions (3)
  1. 2/7/12 2/7/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01435616 Diabetes Mellitus, Type 2

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Age 18 Years and older
Description

Age

Data type

boolean

Have type 2 diabetes mellitus, not treated with insulin, for at least one year prior to the study
Description

Diabetes mellitus, Type 2

Data type

boolean

Have been receiving at least 2 oral antihyperglycemic medication for at least 3 months before entering the study
Description

antihyperglycemic medication

Data type

boolean

Have hemoglobin A1c value between 7.0% and 11.0%, inclusive, at screening
Description

HbA1c 7-11%

Data type

boolean

Are capable of, and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
Description

Insulin therapy and blood glucose monitoring

Data type

boolean

Woman of Childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization and intend to not become pregnant during the trial. Have practiced a reliable method of birth control for at least 6 weeks prior to screening and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug
Description

no pregnancy, no breastfeeding

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
Description

Insulin therapy

Data type

boolean

Use of rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
Description

Other medications

Data type

boolean

Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
Description

medication for weight loss

Data type

boolean

Have had any episodes of severe hypoglycemia within 6 months prior to screening
Description

Hypoglycemia

Data type

boolean

Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
Description

Ketoacidosis

Data type

boolean

Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)
Description

Cardiac disease

Data type

boolean

Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 mg/dL
Description

Renal transplantation

Data type

boolean

Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
Description

Liver disease

Data type

boolean

Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of hemoglobin A1c
Description

Blood transfusion

Data type

boolean

Have active or untreated malignancy, have been in remission from clinically significant malignancy for less than 5 years
Description

Malignancy

Data type

boolean

Have fasting or nonfasting triglycerides greater than 400 mg/dL (greater than 4.5 mmol/L) at screening
Description

Triglycerides greater than 400 mg/dL

Data type

boolean

Are using lipid lowering medication at a dose that has not been stable for 90 days prior to screening
Description

Lipid lowering medication

Data type

boolean

Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening
Description

Niacin and bile acid sequestrants

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Diabetes Mellitus, Non-Insulin-Dependent
Description

Diabetes mellitus type 2

Data type

string

Alias
UMLS CUI
C0011860
SNOMED CT 2010_0731
44054006
MedDRA 13.1
10012613
ICD-10-CM Version 2010
E08-E13
Anti-hyperglycemics
Description

Hypoglycemic agents

Data type

string

Alias
UMLS CUI
C0020616
SNOMED CT 2010_0731
373299009
LOINC Version 232
MTHU016642
Hemoglobin A1c (HbA1c)
Description

Glycosylated hemoglobin A

Data type

string

Alias
UMLS CUI
C0019018
SNOMED CT 2010_0731
33601001
LOINC Version 232
MTHU018890
Self-monitoring of blood glucose
Description

Blood Glucose Self-Monitoring

Data type

string

Alias
UMLS CUI
C0005803
SNOMED CT 2010_0731
308113006
Serum pregnancy test (B-HCG)
Description

Serum pregnancy test

Data type

string

Alias
UMLS CUI
C0430060
SNOMED CT 2010_0731
166434005
Contraception
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Therapeutic insulin
Description

Therapeutic insulin

Data type

string

Alias
UMLS CUI
CL318047
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
SNOMED CT 2010_0731
C0061355
MedDRA 13.1
43004008
rosiglitazone
Description

rosiglitazone

Data type

string

Alias
UMLS CUI
C0289313
Pramlintide
Description

Pramlintide

Data type

string

Alias
UMLS CUI
C0537551
GLP-1 Receptor Agonist
Description

Glucagon-like Peptide 1 Receptor Agonist

Data type

string

Alias
UMLS CUI
C2917359
Weight-Loss Drugs
Description

Weight-Loss Drugs

Data type

string

Alias
UMLS CUI
C0376606
Hypoglycemia
Description

Hypoglycemia

Data type

string

Alias
UMLS CUI
C0220982
SNOMED CT 2010_0731
56051008
MedDRA 13.1
10023379
Ketoacidosis
Description

Ketoacidosis

Data type

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
Hyperosmolar coma associated with diabetes mellitus
Description

Hyperosmolar coma associated with diabetes mellitus

Data type

string

Alias
UMLS CUI
C1720143
SNOMED CT 2010_0731
422126006
Cardiac disease
Description

Cardiac disease

Data type

string

Alias
UMLS CUI
C1275491
SNOMED CT 2010_0731
420816009
New York Heart Association Classification
Description

NYHA

Data type

string

Alias
UMLS CUI
C0022671
SNOMED CT 2010_0731
70536003
MedDRA 13.1
10038533
ICD-9-CM Version 2011
55.6
Renal transplant
Description

Kidney Transplantation

Data type

string

Alias
UMLS CUI
C0011946
SNOMED CT 2010_0731
265764009
MedDRA 13.1
10049051
Renal dialysis
Description

Renal dialysis

Data type

string

Alias
UMLS CUI
C0023895
SNOMED CT 2010_0731
235856003
MedDRA 13.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Liver diseases
Description

Liver disorder

Data type

string

Alias
UMLS CUI
C0023895
SNOMED CT 2010_0731
116859006
MedDRA 13.1
10005835
LOINC Version 232
MTHU020992
Blood transfusion
Description

Blood transfusion

Data type

string

Alias
UMLS CUI
C0005841
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C80
ICD-9-CM Version 2011
199
Malignant Neoplasms
Description

Malignant Neoplasms

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
85600001
LOINC Version 232
MTHU003166
Triglycerides
Description

Triglycerides

Data type

string

Alias
UMLS CUI
C1277252
SNOMED CT 2010_0731
135822005
Lipid lowering drug
Description

Antilipemic agent

Data type

string

Alias
UMLS CUI
C0086440
SNOMED CT 2010_0731
57952007
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
Age
Item
Age 18 Years and older
boolean
Diabetes mellitus, Type 2
Item
Have type 2 diabetes mellitus, not treated with insulin, for at least one year prior to the study
boolean
antihyperglycemic medication
Item
Have been receiving at least 2 oral antihyperglycemic medication for at least 3 months before entering the study
boolean
HbA1c 7-11%
Item
Have hemoglobin A1c value between 7.0% and 11.0%, inclusive, at screening
boolean
Insulin therapy and blood glucose monitoring
Item
Are capable of, and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
boolean
no pregnancy, no breastfeeding
Item
Woman of Childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization and intend to not become pregnant during the trial. Have practiced a reliable method of birth control for at least 6 weeks prior to screening and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug
boolean
Item Group
Exclusion Criteria
Insulin therapy
Item
Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
boolean
Other medications
Item
Use of rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
boolean
medication for weight loss
Item
Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
boolean
Hypoglycemia
Item
Have had any episodes of severe hypoglycemia within 6 months prior to screening
boolean
Ketoacidosis
Item
Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
boolean
Cardiac disease
Item
Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)
boolean
Renal transplantation
Item
Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 mg/dL
boolean
Liver disease
Item
Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
boolean
Blood transfusion
Item
Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of hemoglobin A1c
boolean
Malignancy
Item
Have active or untreated malignancy, have been in remission from clinically significant malignancy for less than 5 years
boolean
Triglycerides greater than 400 mg/dL
Item
Have fasting or nonfasting triglycerides greater than 400 mg/dL (greater than 4.5 mmol/L) at screening
boolean
Lipid lowering medication
Item
Are using lipid lowering medication at a dose that has not been stable for 90 days prior to screening
boolean
Niacin and bile acid sequestrants
Item
Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Diabetes mellitus type 2
Item
Diabetes Mellitus, Non-Insulin-Dependent
string
C0011860 (UMLS CUI)
44054006 (SNOMED CT 2010_0731)
10012613 (MedDRA 13.1)
E08-E13 (ICD-10-CM Version 2010)
Hypoglycemic agents
Item
Anti-hyperglycemics
string
C0020616 (UMLS CUI)
373299009 (SNOMED CT 2010_0731)
MTHU016642 (LOINC Version 232)
Glycosylated hemoglobin A
Item
Hemoglobin A1c (HbA1c)
string
C0019018 (UMLS CUI)
33601001 (SNOMED CT 2010_0731)
MTHU018890 (LOINC Version 232)
Blood Glucose Self-Monitoring
Item
Self-monitoring of blood glucose
string
C0005803 (UMLS CUI)
308113006 (SNOMED CT 2010_0731)
Serum pregnancy test
Item
Serum pregnancy test (B-HCG)
string
C0430060 (UMLS CUI)
166434005 (SNOMED CT 2010_0731)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Therapeutic insulin
Item
Therapeutic insulin
string
CL318047 (UMLS CUI)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
C0061355 (SNOMED CT 2010_0731)
43004008 (MedDRA 13.1)
rosiglitazone
Item
rosiglitazone
string
C0289313 (UMLS CUI)
Pramlintide
Item
Pramlintide
string
C0537551 (UMLS CUI)
Glucagon-like Peptide 1 Receptor Agonist
Item
GLP-1 Receptor Agonist
string
C2917359 (UMLS CUI)
Weight-Loss Drugs
Item
Weight-Loss Drugs
string
C0376606 (UMLS CUI)
Hypoglycemia
Item
Hypoglycemia
string
C0220982 (UMLS CUI)
56051008 (SNOMED CT 2010_0731)
10023379 (MedDRA 13.1)
Ketoacidosis
Item
Ketoacidosis
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
Hyperosmolar coma associated with diabetes mellitus
Item
Hyperosmolar coma associated with diabetes mellitus
string
C1720143 (UMLS CUI)
422126006 (SNOMED CT 2010_0731)
Cardiac disease
Item
Cardiac disease
string
C1275491 (UMLS CUI)
420816009 (SNOMED CT 2010_0731)
NYHA
Item
New York Heart Association Classification
string
C0022671 (UMLS CUI)
70536003 (SNOMED CT 2010_0731)
10038533 (MedDRA 13.1)
55.6 (ICD-9-CM Version 2011)
Kidney Transplantation
Item
Renal transplant
string
C0011946 (UMLS CUI)
265764009 (SNOMED CT 2010_0731)
10049051 (MedDRA 13.1)
Renal dialysis
Item
Renal dialysis
string
C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Liver disorder
Item
Liver diseases
string
C0023895 (UMLS CUI)
116859006 (SNOMED CT 2010_0731)
10005835 (MedDRA 13.1)
MTHU020992 (LOINC Version 232)
Blood transfusion
Item
Blood transfusion
string
C0005841 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C80 (ICD-10-CM Version 2010)
199 (ICD-9-CM Version 2011)
Malignant Neoplasms
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
85600001 (SNOMED CT 2010_0731)
MTHU003166 (LOINC Version 232)
Triglycerides
Item
Triglycerides
string
C1277252 (UMLS CUI)
135822005 (SNOMED CT 2010_0731)
Antilipemic agent
Item
Lipid lowering drug
string
C0086440 (UMLS CUI)
57952007 (SNOMED CT 2010_0731)
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