ID

29006

Descrizione

A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00630825

collegamento

https://clinicaltrials.gov/show/NCT00630825

Keywords

versioni (1)
  1. 20/02/18 20/02/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

20 febbraio 2018

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT00630825

Inglese

Eligibility Diabetes Mellitus Type 2 NCT00630825

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus >3 months by history prior to entering the trial, based on disease diagnostic criteria from the american diabetes association (ada 2007).
Descrizione

Non-Insulin-Dependent Diabetes Mellitus Disease length

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
men or women 18 years of age or older. women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.
Descrizione

Age | Gender Pregnancy test negative | Gender Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0427780
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
have glycosylated hemoglobin (hba1c) of >7.0% to ≤10.5% as determined by central laboratory at screening.
Descrizione

Glucohemoglobin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0202054
have a body mass index (bmi) between 27 and 40 kilograms/meter squared (kg/m^2), inclusive.
Descrizione

Body mass index

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1305855
have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. chlorpropamide or diabinese, glimepiride or amaryl, tolbutamide or orinase, tolazamide or tolinase, glipizide or glucotrol, glyburide also known as micronase, diabeta, or glynase), biguanides (e.g. glucophage or metformin), thiazolidinediones (e.g. rosiglitazone or avandia, or pioglitazone or actos), or dipeptidyl peptidase 4 (dpp-iv) inhibitors (e.g. sitagliptin or januvia). a combination pill of any 2 of these drugs is allowed (1 only), (e.g. metformin and glipizide or metaglip), (e.g. metformin and glyburide or glucovance), (e.g. pioglitazone and glimepiride or duetact), or (e.g. sitagliptin and metformin or janumet).
Descrizione

Oral hypoglycemic Dosage Same Combination | Sulfonylurea | Chlorpropamide | Diabinese | glimepiride | Amaryl | Tolbutamide | Orinase | Tolazamide | Tolinase | Glipizide | Glucotrol | Glyburide | Micronase | Diabeta | Glynase | Biguanides | Glucophage | Metformin | Thiazolidinediones | rosiglitazone | Avandia | pioglitazone | Actos | Dipeptidyl-Peptidase IV Inhibitors | sitagliptin | Januvia | Metaglip | Glucovance | Duetact | Janumet

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0445247
UMLS CUI [1,4]
C0205195
UMLS CUI [2]
C0038766
UMLS CUI [3]
C0008287
UMLS CUI [4]
C0591359
UMLS CUI [5]
C0061323
UMLS CUI [6]
C0595112
UMLS CUI [7]
C0040374
UMLS CUI [8]
C0701229
UMLS CUI [9]
C0040372
UMLS CUI [10]
C0723773
UMLS CUI [11]
C0017642
UMLS CUI [12]
C0701228
UMLS CUI [13]
C0017628
UMLS CUI [14]
C0700712
UMLS CUI [15]
C0700718
UMLS CUI [16]
C2725379
UMLS CUI [17]
C0005382
UMLS CUI [18]
C0591573
UMLS CUI [19]
C0025598
UMLS CUI [20]
C1257987
UMLS CUI [21]
C0289313
UMLS CUI [22]
C0875967
UMLS CUI [23]
C0071097
UMLS CUI [24]
C0875954
UMLS CUI [25]
C1827106
UMLS CUI [26]
C1565750
UMLS CUI [27]
C1702177
UMLS CUI [28]
C1170394
UMLS CUI [29]
C0939344
UMLS CUI [30]
C1735398
UMLS CUI [31]
C1948387
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
have known type 1 diabetes mellitus
Descrizione

Diabetes Mellitus, Insulin-Dependent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011854
have taken glucagon-like peptide-1 (glp-1) or any glp-1 analog drug (byetta)
Descrizione

Glucagon-Like Peptide 1 | Glucagon-Like Peptide 1 Analog | Byetta

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0061355
UMLS CUI [2,1]
C0061355
UMLS CUI [2,2]
C0243071
UMLS CUI [3]
C1636686
have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty [ptca], open heart surgery, or coronary artery bypass graft [cabg]), a transient ischemic attack (tia) or stroke (cerebrovascular accident) in the last 6 months prior to screening.
Descrizione

Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia | Congestive heart failure | Intervention Coronary | Percutaneous Transluminal Coronary Angioplasty | Open heart surgery | Coronary Artery Bypass Surgery | Transient Ischemic Attack | Cerebrovascular accident

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0085612
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C0184661
UMLS CUI [5,2]
C1522318
UMLS CUI [6]
C2936173
UMLS CUI [7]
C0189745
UMLS CUI [8]
C0010055
UMLS CUI [9]
C0007787
UMLS CUI [10]
C0038454
have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. have renal disease or a serum creatinine (blood test) >2 milligrams per deciliter (mg/dl). if taking biguanides (e.g. metformin or glucophage), or dpp-iv inhibitors (e.g. sitagliptin or januvia or janumet), creatinine must be ≤1.5 mg/dl.
Descrizione

Hepatitis | Hepatitis, Chronic | Increased liver function tests | Alanine aminotransferase increased | Pancreatitis, Chronic | Kidney Diseases | Creatinine measurement, serum | Relationship Biguanides | Relationship Metformin | Relationship Glucophage | Relationship Dipeptidyl-Peptidase IV Inhibitors | Relationship sitagliptin | Relationship Januvia | Relationship Janumet

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0019189
UMLS CUI [3]
C0877359
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0149521
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0201976
UMLS CUI [8,1]
C0439849
UMLS CUI [8,2]
C0005382
UMLS CUI [9,1]
C0439849
UMLS CUI [9,2]
C0025598
UMLS CUI [10,1]
C0439849
UMLS CUI [10,2]
C0591573
UMLS CUI [11,1]
C0439849
UMLS CUI [11,2]
C1827106
UMLS CUI [12,1]
C0439849
UMLS CUI [12,2]
C1565750
UMLS CUI [13,1]
C0439849
UMLS CUI [13,2]
C1702177
UMLS CUI [14,1]
C0439849
UMLS CUI [14,2]
C1948387
currently taking prescription or over the counter medications to prevent weight loss.
Descrizione

Weight-Loss Agents Drug Prescriptions | Weight-Loss Agents Non-Prescription Drugs

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0376606
UMLS CUI [1,2]
C0033081
UMLS CUI [2,1]
C0376606
UMLS CUI [2,2]
C0013231
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Similar models

Eligibility Diabetes Mellitus Type 2 NCT00630825

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes mellitus >3 months by history prior to entering the trial, based on disease diagnostic criteria from the american diabetes association (ada 2007).
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age | Gender Pregnancy test negative | Gender Contraceptive methods
Item
men or women 18 years of age or older. women must have a negative pregnancy test and be willing to use birth control during study duration and one month post.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Glucohemoglobin measurement
Item
have glycosylated hemoglobin (hba1c) of >7.0% to ≤10.5% as determined by central laboratory at screening.
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
have a body mass index (bmi) between 27 and 40 kilograms/meter squared (kg/m^2), inclusive.
boolean
C1305855 (UMLS CUI [1])
Oral hypoglycemic Dosage Same Combination | Sulfonylurea | Chlorpropamide | Diabinese | glimepiride | Amaryl | Tolbutamide | Orinase | Tolazamide | Tolinase | Glipizide | Glucotrol | Glyburide | Micronase | Diabeta | Glynase | Biguanides | Glucophage | Metformin | Thiazolidinediones | rosiglitazone | Avandia | pioglitazone | Actos | Dipeptidyl-Peptidase IV Inhibitors | sitagliptin | Januvia | Metaglip | Glucovance | Duetact | Janumet
Item
have been on the same doses for 3 months of any approved combination of 2 oral antihyperglycemic medications in any combination of the following: sulfonylureas (e.g. chlorpropamide or diabinese, glimepiride or amaryl, tolbutamide or orinase, tolazamide or tolinase, glipizide or glucotrol, glyburide also known as micronase, diabeta, or glynase), biguanides (e.g. glucophage or metformin), thiazolidinediones (e.g. rosiglitazone or avandia, or pioglitazone or actos), or dipeptidyl peptidase 4 (dpp-iv) inhibitors (e.g. sitagliptin or januvia). a combination pill of any 2 of these drugs is allowed (1 only), (e.g. metformin and glipizide or metaglip), (e.g. metformin and glyburide or glucovance), (e.g. pioglitazone and glimepiride or duetact), or (e.g. sitagliptin and metformin or janumet).
boolean
C0359086 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0445247 (UMLS CUI [1,3])
C0205195 (UMLS CUI [1,4])
C0038766 (UMLS CUI [2])
C0008287 (UMLS CUI [3])
C0591359 (UMLS CUI [4])
C0061323 (UMLS CUI [5])
C0595112 (UMLS CUI [6])
C0040374 (UMLS CUI [7])
C0701229 (UMLS CUI [8])
C0040372 (UMLS CUI [9])
C0723773 (UMLS CUI [10])
C0017642 (UMLS CUI [11])
C0701228 (UMLS CUI [12])
C0017628 (UMLS CUI [13])
C0700712 (UMLS CUI [14])
C0700718 (UMLS CUI [15])
C2725379 (UMLS CUI [16])
C0005382 (UMLS CUI [17])
C0591573 (UMLS CUI [18])
C0025598 (UMLS CUI [19])
C1257987 (UMLS CUI [20])
C0289313 (UMLS CUI [21])
C0875967 (UMLS CUI [22])
C0071097 (UMLS CUI [23])
C0875954 (UMLS CUI [24])
C1827106 (UMLS CUI [25])
C1565750 (UMLS CUI [26])
C1702177 (UMLS CUI [27])
C1170394 (UMLS CUI [28])
C0939344 (UMLS CUI [29])
C1735398 (UMLS CUI [30])
C1948387 (UMLS CUI [31])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
have known type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Glucagon-Like Peptide 1 | Glucagon-Like Peptide 1 Analog | Byetta
Item
have taken glucagon-like peptide-1 (glp-1) or any glp-1 analog drug (byetta)
boolean
C0061355 (UMLS CUI [1])
C0061355 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C1636686 (UMLS CUI [3])
Angina, Unstable | Myocardial Infarction | Ventricular arrhythmia | Congestive heart failure | Intervention Coronary | Percutaneous Transluminal Coronary Angioplasty | Open heart surgery | Coronary Artery Bypass Surgery | Transient Ischemic Attack | Cerebrovascular accident
Item
have a history of unstable angina, heart attack (myocardial infarction), heart arrhythmia (ventricular), congestive heart failure, or other coronary intervention (percutaneous transluminal coronary angioplasty [ptca], open heart surgery, or coronary artery bypass graft [cabg]), a transient ischemic attack (tia) or stroke (cerebrovascular accident) in the last 6 months prior to screening.
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0085612 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0184661 (UMLS CUI [5,1])
C1522318 (UMLS CUI [5,2])
C2936173 (UMLS CUI [6])
C0189745 (UMLS CUI [7])
C0010055 (UMLS CUI [8])
C0007787 (UMLS CUI [9])
C0038454 (UMLS CUI [10])
Hepatitis | Hepatitis, Chronic | Increased liver function tests | Alanine aminotransferase increased | Pancreatitis, Chronic | Kidney Diseases | Creatinine measurement, serum | Relationship Biguanides | Relationship Metformin | Relationship Glucophage | Relationship Dipeptidyl-Peptidase IV Inhibitors | Relationship sitagliptin | Relationship Januvia | Relationship Janumet
Item
have acute or chronic hepatitis or elevated liver function tests (alanine transaminase), a history of chronic or recurrent pancreatitis. have renal disease or a serum creatinine (blood test) >2 milligrams per deciliter (mg/dl). if taking biguanides (e.g. metformin or glucophage), or dpp-iv inhibitors (e.g. sitagliptin or januvia or janumet), creatinine must be ≤1.5 mg/dl.
boolean
C0019158 (UMLS CUI [1])
C0019189 (UMLS CUI [2])
C0877359 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0149521 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0439849 (UMLS CUI [8,1])
C0005382 (UMLS CUI [8,2])
C0439849 (UMLS CUI [9,1])
C0025598 (UMLS CUI [9,2])
C0439849 (UMLS CUI [10,1])
C0591573 (UMLS CUI [10,2])
C0439849 (UMLS CUI [11,1])
C1827106 (UMLS CUI [11,2])
C0439849 (UMLS CUI [12,1])
C1565750 (UMLS CUI [12,2])
C0439849 (UMLS CUI [13,1])
C1702177 (UMLS CUI [13,2])
C0439849 (UMLS CUI [14,1])
C1948387 (UMLS CUI [14,2])
Weight-Loss Agents Drug Prescriptions | Weight-Loss Agents Non-Prescription Drugs
Item
currently taking prescription or over the counter medications to prevent weight loss.
boolean
C0376606 (UMLS CUI [1,1])
C0033081 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
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