ID

29118

Beschreibung

Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2); ODM derived from: https://clinicaltrials.gov/show/NCT00659477

Link

https://clinicaltrials.gov/show/NCT00659477

Stichworte

Versionen (1)
  1. 26.02.18 26.02.18 -
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See clinicaltrials.gov

Hochgeladen am

26. Februar 2018

DOI

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Eligibility Diabetes Mellitus, Type 2 NCT00659477

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00659477

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetes type 2
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
patients treated nph insulin with stable dosage of oads (oral antidiabetic drugs) for at least 2 months prior to study start and oads treatment with metformin at least 1,7 g /day in combination with sulfonylurea or glinides.
Beschreibung

NPH insulin | Antidiabetics Oral Dosage Stable | Metformin U/day | Sulfonylurea | Glinides

Datentyp

boolean

Alias
UMLS CUI [1]
C0021658
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C0025598
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C0038766
UMLS CUI [5]
C3537178
patients must have a hba1c range of >= 4,5% ( 6,2% dcct/diabetes control and complication trials) and <= 8% ( 9,4 % dcct/diabetes control and complication trials)
Beschreibung

Glucohemoglobin measurement | HbA1c measurement (DCCT aligned)

Datentyp

boolean

Alias
UMLS CUI [1]
C0202054
UMLS CUI [2]
C1277712
ability and willingness to perform continuous glucose monitoring system / cgms (examination within the study)
Beschreibung

Performance Glucose monitoring system Continuous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0597198
UMLS CUI [1,2]
C3873850
UMLS CUI [1,3]
C0549178
written informed consent obtained prior to enrollment in the study
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study
Beschreibung

Gender Childbearing Potential Absent | Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. fasting value c peptide <= 400 pmol/l
Beschreibung

Fasting C-peptide level

Datentyp

boolean

Alias
UMLS CUI [1]
C2208720
2. active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable rapidly progressing retinopathy that may require photocoagulation or surgery during the study.
Beschreibung

Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Progressing Rapidly Unstable

Datentyp

boolean

Alias
UMLS CUI [1]
C0154830
UMLS CUI [2]
C0023694
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C0035309
UMLS CUI [4,2]
C0205329
UMLS CUI [4,3]
C0456962
UMLS CUI [4,4]
C0443343
3. pregnant women or women planning gravidity during clinical study protocol
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
4. breast-feeding
Beschreibung

Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
5. history of hypersensitivity to the study drugs or to drugs with a similar chemical structure
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0220807
UMLS CUI [2,4]
C2348205
6. treatment with systemic corticosteroids in the 3 months prior to study entry and during study and other treatment, that can significantly have impression to glycaemia.
Beschreibung

CORTICOSTEROIDS FOR SYSTEMIC USE | Therapeutic procedure Influence Glycemia

Datentyp

boolean

Alias
UMLS CUI [1]
C3653708
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0005802
7. likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
Beschreibung

Requirement Illicit Drugs Probable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0086190
UMLS CUI [1,3]
C0033204
8. clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
Beschreibung

Cardiovascular Diseases | Liver diseases | Nervous system disorder | Endocrine System Diseases | Disease Major | Implementation Protocol Difficult | Interpretation Research results Difficult

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0027765
UMLS CUI [4]
C0014130
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0205164
UMLS CUI [6,1]
C1708476
UMLS CUI [6,2]
C2348563
UMLS CUI [6,3]
C0332218
UMLS CUI [7,1]
C0459471
UMLS CUI [7,2]
C0683954
UMLS CUI [7,3]
C0332218
9. impaired hepatic function as shown by alamine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal range at study entry
Beschreibung

Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
10. impaired renal function as shown by serum creatinine >/= 133 micromol/l in men and >/= 124 micromol/l in women at study entry
Beschreibung

Renal Insufficiency | Creatinine measurement, serum | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
11. history of drug or alcohol abuse in the last year
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
12. mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
Beschreibung

Mental condition Comprehension Study Protocol Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C1299582
13. patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
Beschreibung

Protocol Compliance Unlikely | Uncooperative attitude | Follow-up visit Unable | Completion of clinical trial Unlikely

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0750558
UMLS CUI [2]
C2188045
UMLS CUI [3,1]
C0589121
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C2732579
UMLS CUI [4,2]
C0750558
14. use of insulin glargine outside the scope of the current spc (summary of product characteristics)
Beschreibung

Insulin Glargine Specific

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0907402
UMLS CUI [1,2]
C0205369
16. patients included in other clinical studies
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beschreibung

Study Subject Participation Status Aspect Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1879746
UMLS CUI [1,3]
C1524062
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00659477

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes type 2
boolean
C0011860 (UMLS CUI [1])
NPH insulin | Antidiabetics Oral Dosage Stable | Metformin U/day | Sulfonylurea | Glinides
Item
patients treated nph insulin with stable dosage of oads (oral antidiabetic drugs) for at least 2 months prior to study start and oads treatment with metformin at least 1,7 g /day in combination with sulfonylurea or glinides.
boolean
C0021658 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0025598 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0038766 (UMLS CUI [4])
C3537178 (UMLS CUI [5])
Glucohemoglobin measurement | HbA1c measurement (DCCT aligned)
Item
patients must have a hba1c range of >= 4,5% ( 6,2% dcct/diabetes control and complication trials) and <= 8% ( 9,4 % dcct/diabetes control and complication trials)
boolean
C0202054 (UMLS CUI [1])
C1277712 (UMLS CUI [2])
Performance Glucose monitoring system Continuous
Item
ability and willingness to perform continuous glucose monitoring system / cgms (examination within the study)
boolean
C0597198 (UMLS CUI [1,1])
C3873850 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Informed Consent
Item
written informed consent obtained prior to enrollment in the study
boolean
C0021430 (UMLS CUI [1])
Gender Childbearing Potential Absent | Childbearing Potential Pregnancy Absent | Childbearing Potential Contraceptive methods
Item
women are either not of childbearing potential or women of childbearing potential must not be pregnant and must use a reliable contraceptive measure for the duration of the study
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Fasting C-peptide level
Item
1. fasting value c peptide <= 400 pmol/l
boolean
C2208720 (UMLS CUI [1])
Proliferative diabetic retinopathy | Light Coagulation | Operative Surgical Procedures | Retinal Disease Progressing Rapidly Unstable
Item
2. active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable rapidly progressing retinopathy that may require photocoagulation or surgery during the study.
boolean
C0154830 (UMLS CUI [1])
C0023694 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0035309 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
C0456962 (UMLS CUI [4,3])
C0443343 (UMLS CUI [4,4])
Pregnancy | Pregnancy, Planned
Item
3. pregnant women or women planning gravidity during clinical study protocol
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Breast Feeding
Item
4. breast-feeding
boolean
C0006147 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Chemical Structure Similar
Item
5. history of hypersensitivity to the study drugs or to drugs with a similar chemical structure
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0220807 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
CORTICOSTEROIDS FOR SYSTEMIC USE | Therapeutic procedure Influence Glycemia
Item
6. treatment with systemic corticosteroids in the 3 months prior to study entry and during study and other treatment, that can significantly have impression to glycaemia.
boolean
C3653708 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0005802 (UMLS CUI [2,3])
Requirement Illicit Drugs Probable
Item
7. likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
boolean
C1514873 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
C0033204 (UMLS CUI [1,3])
Cardiovascular Diseases | Liver diseases | Nervous system disorder | Endocrine System Diseases | Disease Major | Implementation Protocol Difficult | Interpretation Research results Difficult
Item
8. clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0027765 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0012634 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
C1708476 (UMLS CUI [6,1])
C2348563 (UMLS CUI [6,2])
C0332218 (UMLS CUI [6,3])
C0459471 (UMLS CUI [7,1])
C0683954 (UMLS CUI [7,2])
C0332218 (UMLS CUI [7,3])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
9. impaired hepatic function as shown by alamine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal range at study entry
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Creatinine measurement, serum | Gender
Item
10. impaired renal function as shown by serum creatinine >/= 133 micromol/l in men and >/= 124 micromol/l in women at study entry
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Substance Use Disorders
Item
11. history of drug or alcohol abuse in the last year
boolean
C0038586 (UMLS CUI [1])
Mental condition Comprehension Study Protocol Unable
Item
12. mental condition causing the patient unable to understand the nature, scope and possible consequences of the study
boolean
C3840291 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Protocol Compliance Unlikely | Uncooperative attitude | Follow-up visit Unable | Completion of clinical trial Unlikely
Item
13. patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
C2188045 (UMLS CUI [2])
C0589121 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C2732579 (UMLS CUI [4,1])
C0750558 (UMLS CUI [4,2])
Insulin Glargine Specific
Item
14. use of insulin glargine outside the scope of the current spc (summary of product characteristics)
boolean
C0907402 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Study Subject Participation Status
Item
16. patients included in other clinical studies
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Aspect Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C1879746 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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