ID

29196

Descrizione

Linagliptin 2.5 mg Twice Daily Versus 5 mg Once Daily as add-on Therapy to Twice Daily Metformin in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01012037

collegamento

https://clinicaltrials.gov/show/NCT01012037

Keywords

versioni (1)
  1. 06/03/18 06/03/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

6 marzo 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01012037

Inglese

Eligibility Diabetes Mellitus, Type 2 NCT01012037

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of type 2 diabetes mellitus.
Descrizione

Diabetes Mellitus, Non-Insulin-Dependent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011860
2. current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. metformin must be administered in twice daily dosing regimen. patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
Descrizione

Metformin Dose Frequency | Antidiabetics Quantity

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0439603
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C1265611
3. glycosylated haemoglobin (hba1c) is between 7.0% - 10.0%.
Descrizione

Glucohemoglobin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0202054
4. body mass index (bmi) </=45 kg/m2.
Descrizione

Body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. treatment with extended release metformin.
Descrizione

Metformin Extended Release

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0025598
UMLS CUI [1,2]
C1707968
2. uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dl or 13.3 mmol/l).
Descrizione

Hyperglycemia Uncontrolled | Plasma fasting glucose measurement

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020456
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0583513
3. myocardial infarction (mi), stroke or transient ischaemic attack (tia) within 6 months prior to informed consent.
Descrizione

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
4. impaired hepatic or renal function, or gastric bypass surgery.
Descrizione

Liver Dysfunction | Renal Insufficiency | Gastric Bypass

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0017125
5. treatment with glitazones, glucagon like peptide-1 (glp-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
Descrizione

Thiazolidinediones | GLP-1 Mimetics | Anti-Obesity Agents | Insulin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1257987
UMLS CUI [2]
C3273809
UMLS CUI [3]
C0376607
UMLS CUI [4]
C0021641
6. current treatment with systemic steroids or change in dosage of thyroid hormones.
Descrizione

Systemic steroids | Thyroid Hormones Dosage Change

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2,1]
C0040135
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
7. alcohol or drug abuse within 3 months of informed consent.
Descrizione

Substance Use Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
8. participation in another trial with investigational drug within 2 months prior to informed consent.
Descrizione

Study Subject Participation Status | Investigational New Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
9. pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.
Descrizione

Premenopausal state | Breast Feeding | Pregnancy | Contraceptive methods Absent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032961
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0332197
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01012037

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diagnosis of type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Frequency | Antidiabetics Quantity
Item
2. current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. metformin must be administered in twice daily dosing regimen. patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Glucohemoglobin measurement
Item
3. glycosylated haemoglobin (hba1c) is between 7.0% - 10.0%.
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
4. body mass index (bmi) </=45 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metformin Extended Release
Item
1. treatment with extended release metformin.
boolean
C0025598 (UMLS CUI [1,1])
C1707968 (UMLS CUI [1,2])
Hyperglycemia Uncontrolled | Plasma fasting glucose measurement
Item
2. uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dl or 13.3 mmol/l).
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0583513 (UMLS CUI [2])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
3. myocardial infarction (mi), stroke or transient ischaemic attack (tia) within 6 months prior to informed consent.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Liver Dysfunction | Renal Insufficiency | Gastric Bypass
Item
4. impaired hepatic or renal function, or gastric bypass surgery.
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0017125 (UMLS CUI [3])
Thiazolidinediones | GLP-1 Mimetics | Anti-Obesity Agents | Insulin
Item
5. treatment with glitazones, glucagon like peptide-1 (glp-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
boolean
C1257987 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C0376607 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
Systemic steroids | Thyroid Hormones Dosage Change
Item
6. current treatment with systemic steroids or change in dosage of thyroid hormones.
boolean
C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
Substance Use Disorders
Item
7. alcohol or drug abuse within 3 months of informed consent.
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
8. participation in another trial with investigational drug within 2 months prior to informed consent.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Premenopausal state | Breast Feeding | Pregnancy | Contraceptive methods Absent
Item
9. pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.
boolean
C0232969 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
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