ID

20693

Beschreibung

Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR); ODM derived from: https://clinicaltrials.gov/show/NCT00437554

Link

https://clinicaltrials.gov/show/NCT00437554

Stichworte

Versionen (1)
  1. 12.03.17 12.03.17 -
Hochgeladen am

12. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT00437554

Englisch

Eligibility Diabetes Mellitus, Type 2 NCT00437554

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with type 2 dm diagnosed for at least 3 months but no longer than 10 years before screening;
Beschreibung

Non-Insulin-Dependent Diabetes Mellitus disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
- bmi ≤ 40 kg/m²;
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
a negative pregnancy test for all females of childbearing potential
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening;
Beschreibung

metabolic; complications | Diabetic Ketoacidosis | Hyperosmolar Nonketotic Coma

Datentyp

boolean

Alias
UMLS CUI [1]
C1393263
UMLS CUI [2]
C0011880
UMLS CUI [3]
C0020457
current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening;
Beschreibung

Antidiabetics Oral | Sulfonylurea | Metformin | Thiazolidinediones

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0038766
UMLS CUI [3]
C0025598
UMLS CUI [4]
C1257987
concomitant treatment prohibited during the study period;
Beschreibung

Concomitant Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1707479
any oral anti-diabetic drugs other than study medication
Beschreibung

Antidiabetics Oral | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0935929
UMLS CUI [1,2]
C1527415
UMLS CUI [2]
C0013230
any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study
Beschreibung

Insulin regime Acute metabolic decompensation | Insulin regime Sepsis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C2673978
UMLS CUI [2,1]
C0557978
UMLS CUI [2,2]
C0243026
intermittent use of systemic corticosteroids or large dose of inhaled steroids
Beschreibung

CORTICOSTEROIDS FOR SYSTEMIC USE Intermittent | inhaled steroids Dose Large

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0205267
UMLS CUI [2,1]
C2065041
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0549177
subjects with clinically significant renal (serum creatinine level >1.5 mg/dl in male and >1.4 mg/dl in female) or hepatic disease (alanine aminotransferase (alt) and aspartate aminotransferase (ast) >2x upper limit of normal (uln));
Beschreibung

Kidney Disease | Creatinine measurement, serum | Gender | Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0151905
UMLS CUI [6]
C0151904
subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.)
Beschreibung

Cardiovascular Disease Severe | Heart failure | Myocardial Infarction | Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0018801
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0038454
clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
Beschreibung

Laboratory test result abnormal | Medical condition Affecting Protocol Compliance | Medical condition Affecting research results

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0683954
pregnant or lactating females;
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of drug or alcohol abuse;
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
subjects with known hypersensitivity to glimepirides, or metformin; night-shift workers;
Beschreibung

Hypersensitivity glimepiride | Metformin allergy | Night shift worker

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0061323
UMLS CUI [2]
C0571648
UMLS CUI [3]
C0555008
treatment with any investigational product in the last 3 months before study entry;
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 2 NCT00437554

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus disease length
Item
subjects with type 2 dm diagnosed for at least 3 months but no longer than 10 years before screening;
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Body mass index
Item
- bmi ≤ 40 kg/m²;
boolean
C1305855 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
a negative pregnancy test for all females of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
metabolic; complications | Diabetic Ketoacidosis | Hyperosmolar Nonketotic Coma
Item
a history of acute metabolic complications such as diabetic ketoacidosis or hyperosmolar nonketotic coma within 3 months before screening;
boolean
C1393263 (UMLS CUI [1])
C0011880 (UMLS CUI [2])
C0020457 (UMLS CUI [3])
Antidiabetics Oral | Sulfonylurea | Metformin | Thiazolidinediones
Item
current therapy with any oral anti-diabetic drugs or previous use in the 4 weeks other than sulfonylureas or metformin (8 weeks in case of thiazolidinedione) before screening;
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0038766 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1257987 (UMLS CUI [4])
Concomitant Therapy
Item
concomitant treatment prohibited during the study period;
boolean
C1707479 (UMLS CUI [1])
Antidiabetics Oral | Investigational New Drugs
Item
any oral anti-diabetic drugs other than study medication
boolean
C0935929 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Insulin regime Acute metabolic decompensation | Insulin regime Sepsis
Item
any insulin therapy over 7 days consecutively or intermittently in order to treat acute metabolic decompensation or systemic infection during the study
boolean
C0557978 (UMLS CUI [1,1])
C2673978 (UMLS CUI [1,2])
C0557978 (UMLS CUI [2,1])
C0243026 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE Intermittent | inhaled steroids Dose Large
Item
intermittent use of systemic corticosteroids or large dose of inhaled steroids
boolean
C3653708 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C2065041 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0549177 (UMLS CUI [2,3])
Kidney Disease | Creatinine measurement, serum | Gender | Liver disease | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
subjects with clinically significant renal (serum creatinine level >1.5 mg/dl in male and >1.4 mg/dl in female) or hepatic disease (alanine aminotransferase (alt) and aspartate aminotransferase (ast) >2x upper limit of normal (uln));
boolean
C0022658 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
C0151904 (UMLS CUI [6])
Cardiovascular Disease Severe | Heart failure | Myocardial Infarction | Cerebrovascular accident
Item
subjects with acute and severe cardiovascular disease (e.g. heart failure, myocardiac infarction, stroke etc.)
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Laboratory test result abnormal | Medical condition Affecting Protocol Compliance | Medical condition Affecting research results
Item
clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study in the opinion of the investigator and/or sponsor;
boolean
C0438215 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
history of drug or alcohol abuse;
boolean
C0038586 (UMLS CUI [1])
Hypersensitivity glimepiride | Metformin allergy | Night shift worker
Item
subjects with known hypersensitivity to glimepirides, or metformin; night-shift workers;
boolean
C0020517 (UMLS CUI [1,1])
C0061323 (UMLS CUI [1,2])
C0571648 (UMLS CUI [2])
C0555008 (UMLS CUI [3])
Investigational New Drugs
Item
treatment with any investigational product in the last 3 months before study entry;
boolean
C0013230 (UMLS CUI [1])
Study Subject Participation Status
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])
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