ID

29090

Beskrivning

Efficacy of Colesevelam in Subjects With Type 1 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT00938405

Länk

https://clinicaltrials.gov/show/NCT00938405

Nyckelord

Versioner (1)
  1. 2018-02-23 2018-02-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 februari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 1 NCT00938405

Engelsk

Eligibility Diabetes Mellitus, Type 1 NCT00938405

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
all subjects will be on stable doses of insulin using mdi or csii (basal insulin-
Beskrivning

Insulin Dose Stable | Injection of insulin Daily Dose Multiple | Continuous subcutaneous infusion of insulin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0199782
UMLS CUI [2,2]
C2348070
UMLS CUI [2,3]
C0439064
UMLS CUI [3]
C0393124
lantus or levemir; bolus- humalog, novolog, apidra, humulin regular), for three months prior to enrollment.
Beskrivning

Basal insulin Lantus | Basal insulin Levemir | Bolus Humalog | Bolus NovoLog | Bolus Apidra | Bolus Humulin R

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0650607
UMLS CUI [1,2]
C0876064
UMLS CUI [2,1]
C0650607
UMLS CUI [2,2]
C1314782
UMLS CUI [3,1]
C1705509
UMLS CUI [3,2]
C0528249
UMLS CUI [4,1]
C1705509
UMLS CUI [4,2]
C0939412
UMLS CUI [5,1]
C1705509
UMLS CUI [5,2]
C1654827
UMLS CUI [6,1]
C1705509
UMLS CUI [6,2]
C0306371
type 1 diabetes duration > 3 years.
Beskrivning

Insulin-Dependent Diabetes Mellitus Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0449238
6.5% ≤ a1c ≤ 9.0%.
Beskrivning

Glucohemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202054
male or female ≥ 18 and ≤ 65 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ability and willingness to adhere to the protocol including multiple daily oral doses of study drug or placebo and week-long cgm wear.
Beskrivning

Protocol Compliance | Investigational New Drugs Oral Daily Dose Multiple | Placebos | Glucose measurement by monitoring device

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C2348070
UMLS CUI [2,4]
C0439064
UMLS CUI [3]
C0032042
UMLS CUI [4]
C0202048
ldl-c > 100 mg/dl.
Beskrivning

Serum LDL cholesterol measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0428474
willing to adhere to colesevelam dosage instructions, including administration of drugs with a known interaction at least 4 hours prior to colesevelam. females using oral contraceptives containing ethinyl estradiol and norethindrone must be willing to administer their doses at least four hours prior to using colesevelam.
Beskrivning

colesevelam | Adherence Dosage Instructions | Administration of medication Drug Interactions | Gender | Oral Contraceptives Containing Ethinyl Estradiol | Oral Contraceptives Containing Norethindrone

Datatyp

boolean

Alias
UMLS CUI [1]
C0541155
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1442085
UMLS CUI [3,1]
C3469597
UMLS CUI [3,2]
C0687133
UMLS CUI [4]
C0079399
UMLS CUI [5,1]
C0009905
UMLS CUI [5,2]
C0332256
UMLS CUI [5,3]
C0015011
UMLS CUI [6,1]
C0009905
UMLS CUI [6,2]
C0332256
UMLS CUI [6,3]
C0028356
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
advanced retinopathy needing laser procedure or vitrectomy.
Beskrivning

Retinal Disease Advanced | Patient need for Laser procedure | Patient need for Vitrectomy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C1562720
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0042903
unstable nephropathy (serum creatinine > 2.0 mg/dl or macroproteinuria (albumin excretion rate > 200 ug/ min).
Beskrivning

Kidney Disease Unstable | Creatinine measurement, serum | Macro Proteinuria | Albumin excretion rate measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0201976
UMLS CUI [3,1]
C2984010
UMLS CUI [3,2]
C0033687
UMLS CUI [4]
C0585937
any unexplained severe hypoglycemia within the last six months.
Beskrivning

Hypoglycemia Severe Unknown

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0439673
bmi > 35.0.
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
currently on a pre-existing bile acid sequestrant therapy, glyburide, levothyroxine, phenytoin, or warfarin.
Beskrivning

Therapeutic procedure Pre-existing | Bile acid sequestrants | Glyburide | Thyroxine | Phenytoin | Warfarin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C2917337
UMLS CUI [3]
C0017628
UMLS CUI [4]
C0040165
UMLS CUI [5]
C0031507
UMLS CUI [6]
C0043031
pregnant, planning a pregnancy, or not using an adequate method of birth control.
Beskrivning

Pregnancy | Pregnancy, Planned | Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332268
any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent.
Beskrivning

Condition Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Limited | Condition Limiting Informed Consent Validity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0021430
UMLS CUI [3,4]
C2349101
use of any medication known to modify glucose values other than insulin (i.e. corticosteroids or oral antidiabetics).
Beskrivning

Pharmaceutical Preparation modifies Glucose level | Exception Insulin | Adrenal Cortex Hormones | Antidiabetics Oral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0428548
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021641
UMLS CUI [3]
C0001617
UMLS CUI [4,1]
C0935929
UMLS CUI [4,2]
C1527415
a history of bowel obstruction.
Beskrivning

Intestinal Obstruction

Datatyp

boolean

Alias
UMLS CUI [1]
C0021843
serum triglyceride (tg) concentrations >500 mg/dl.
Beskrivning

Serum Triglyceride Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0542495
a history of hypertriglyceridemia induced pancreatitis.
Beskrivning

Pancreatitis Hypertriglyceridemia Induced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030305
UMLS CUI [1,2]
C0020557
UMLS CUI [1,3]
C0205263
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Similar models

Eligibility Diabetes Mellitus, Type 1 NCT00938405

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin Dose Stable | Injection of insulin Daily Dose Multiple | Continuous subcutaneous infusion of insulin
Item
all subjects will be on stable doses of insulin using mdi or csii (basal insulin-
boolean
C0021641 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0199782 (UMLS CUI [2,1])
C2348070 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
C0393124 (UMLS CUI [3])
Basal insulin Lantus | Basal insulin Levemir | Bolus Humalog | Bolus NovoLog | Bolus Apidra | Bolus Humulin R
Item
lantus or levemir; bolus- humalog, novolog, apidra, humulin regular), for three months prior to enrollment.
boolean
C0650607 (UMLS CUI [1,1])
C0876064 (UMLS CUI [1,2])
C0650607 (UMLS CUI [2,1])
C1314782 (UMLS CUI [2,2])
C1705509 (UMLS CUI [3,1])
C0528249 (UMLS CUI [3,2])
C1705509 (UMLS CUI [4,1])
C0939412 (UMLS CUI [4,2])
C1705509 (UMLS CUI [5,1])
C1654827 (UMLS CUI [5,2])
C1705509 (UMLS CUI [6,1])
C0306371 (UMLS CUI [6,2])
Insulin-Dependent Diabetes Mellitus Duration
Item
type 1 diabetes duration > 3 years.
boolean
C0011854 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Glucohemoglobin measurement
Item
6.5% ≤ a1c ≤ 9.0%.
boolean
C0202054 (UMLS CUI [1])
Age
Item
male or female ≥ 18 and ≤ 65 years of age.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance | Investigational New Drugs Oral Daily Dose Multiple | Placebos | Glucose measurement by monitoring device
Item
ability and willingness to adhere to the protocol including multiple daily oral doses of study drug or placebo and week-long cgm wear.
boolean
C0525058 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C2348070 (UMLS CUI [2,3])
C0439064 (UMLS CUI [2,4])
C0032042 (UMLS CUI [3])
C0202048 (UMLS CUI [4])
Serum LDL cholesterol measurement
Item
ldl-c > 100 mg/dl.
boolean
C0428474 (UMLS CUI [1])
colesevelam | Adherence Dosage Instructions | Administration of medication Drug Interactions | Gender | Oral Contraceptives Containing Ethinyl Estradiol | Oral Contraceptives Containing Norethindrone
Item
willing to adhere to colesevelam dosage instructions, including administration of drugs with a known interaction at least 4 hours prior to colesevelam. females using oral contraceptives containing ethinyl estradiol and norethindrone must be willing to administer their doses at least four hours prior to using colesevelam.
boolean
C0541155 (UMLS CUI [1])
C1510802 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1442085 (UMLS CUI [2,3])
C3469597 (UMLS CUI [3,1])
C0687133 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4])
C0009905 (UMLS CUI [5,1])
C0332256 (UMLS CUI [5,2])
C0015011 (UMLS CUI [5,3])
C0009905 (UMLS CUI [6,1])
C0332256 (UMLS CUI [6,2])
C0028356 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Retinal Disease Advanced | Patient need for Laser procedure | Patient need for Vitrectomy
Item
advanced retinopathy needing laser procedure or vitrectomy.
boolean
C0035309 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0686904 (UMLS CUI [2,1])
C1562720 (UMLS CUI [2,2])
C0686904 (UMLS CUI [3,1])
C0042903 (UMLS CUI [3,2])
Kidney Disease Unstable | Creatinine measurement, serum | Macro Proteinuria | Albumin excretion rate measurement
Item
unstable nephropathy (serum creatinine > 2.0 mg/dl or macroproteinuria (albumin excretion rate > 200 ug/ min).
boolean
C0022658 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
C2984010 (UMLS CUI [3,1])
C0033687 (UMLS CUI [3,2])
C0585937 (UMLS CUI [4])
Hypoglycemia Severe Unknown
Item
any unexplained severe hypoglycemia within the last six months.
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
Body mass index
Item
bmi > 35.0.
boolean
C1305855 (UMLS CUI [1])
Therapeutic procedure Pre-existing | Bile acid sequestrants | Glyburide | Thyroxine | Phenytoin | Warfarin
Item
currently on a pre-existing bile acid sequestrant therapy, glyburide, levothyroxine, phenytoin, or warfarin.
boolean
C0087111 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C2917337 (UMLS CUI [2])
C0017628 (UMLS CUI [3])
C0040165 (UMLS CUI [4])
C0031507 (UMLS CUI [5])
C0043031 (UMLS CUI [6])
Pregnancy | Pregnancy, Planned | Contraceptive methods Lacking
Item
pregnant, planning a pregnancy, or not using an adequate method of birth control.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Condition Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Limited | Condition Limiting Informed Consent Validity
Item
any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C2349101 (UMLS CUI [3,4])
Pharmaceutical Preparation modifies Glucose level | Exception Insulin | Adrenal Cortex Hormones | Antidiabetics Oral
Item
use of any medication known to modify glucose values other than insulin (i.e. corticosteroids or oral antidiabetics).
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0428548 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0021641 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
Intestinal Obstruction
Item
a history of bowel obstruction.
boolean
C0021843 (UMLS CUI [1])
Serum Triglyceride Measurement
Item
serum triglyceride (tg) concentrations >500 mg/dl.
boolean
C0542495 (UMLS CUI [1])
Pancreatitis Hypertriglyceridemia Induced
Item
a history of hypertriglyceridemia induced pancreatitis.
boolean
C0030305 (UMLS CUI [1,1])
C0020557 (UMLS CUI [1,2])
C0205263 (UMLS CUI [1,3])
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