Informatie:
Fout:
ID
28843
Beschrijving
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Run-In - Visit 3
Trefwoorden
Versies (2)
- 08-02-18 08-02-18 -
- 08-02-18 08-02-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
8 februari 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723
Screening - Visit 2
- StudyEvent: ODM
Similar models
Screening - Visit 2
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
American Hispanic (1)
CL Item
Arabic/North African (2)
CL Item
Black (3)
CL Item
East & South East Asian (4)
CL Item
Japanese (5)
CL Item
South Asian (6)
CL Item
White/Caucasian (7)
CL Item
Other (8)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Blood Pressure - sitting, Systolic
Item
Blood Pressure - sitting, Systolic
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
Blood Pressure - sitting, Diastolic
Item
Blood Pressure - sitting, Diastolic
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Cardiovascular Medical History
C0262926 (UMLS CUI-1)
C0007222 (UMLS CUI-2)
C0007222 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
Item
Ischaemic heart disease without cardiomyopathy
integer
C1869045 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
Item
Ischaemic heart disease with cardiomyopathy
integer
C1869045 (UMLS CUI [1,1])
C0878544 (UMLS CUI [1,2])
C0878544 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Past (1)
CL Item
No medical history (2)
CL Item
Past (1)
CL Item
No medical history (2)
CL Item
Past (1)
CL Item
No medical history (2)
CL Item
Past (1)
CL Item
No medical history (2)
CL Item
Past (1)
CL Item
No medical history (2)
CL Item
Past (1)
CL Item
No medical history (2)
CL Item
Past (1)
CL Item
No medical history (2)
Item
Vascular bypass graft (other than coronary)
integer
C0863745 (UMLS CUI [1])
CL Item
Past (1)
CL Item
No medical history (2)
Item Group
Diabetes Medical History
C0011849 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
C0262926 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
Item
Diabetic foot ulcer
integer
C0085119 (UMLS CUI [1,1])
C0206172 (UMLS CUI [1,2])
C0206172 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
Item
Proteinuria/ nephropathy
integer
C0033687 (UMLS CUI [1])
C0011881 (UMLS CUI [2])
C0011881 (UMLS CUI [2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
Item
Chronic renal Insufficiency / chronic renal failure
integer
C0022661 (UMLS CUI [1])
C0403447 (UMLS CUI [2])
C0403447 (UMLS CUI [2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
Item Group
Other Medical Conditions of Interest
C0012634 (UMLS CUI-1)
C0009488 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0009488 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical history (3)
Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
lab samples
Item
Were lab samples obtained?
boolean
C0005834 (UMLS CUI [1])
C0200354 (UMLS CUI [2])
C0200354 (UMLS CUI [2])
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Item Group
Pre-Study Diabetes Treatment
C0087111 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0011849 (UMLS CUI-3)
C0013227 (UMLS CUI-2)
C0011849 (UMLS CUI-3)
Item
What was the most recent treatment for Diabetes that was taken prior to the study?
integer
C0013227 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,2])
Code List
What was the most recent treatment for Diabetes that was taken prior to the study?
CL Item
Drug Naive (1)
CL Item
Oral antidiabetic monotherapy (2)
CL Item
Oral antidiabetic dual therapy (3)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
inclusion criteria
Item
Did the subject meet all of the inclusion criteria?
boolean
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
Item
inclusion criteria the subject failed
integer
C1512693 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1516637 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
CL Item
Subjects with a clinical diagnosis of type 2 diabetes mellitus according to guidelines set forth by the American Diabetes Association (ADA), Canadian Diabetes Association (CDA), or American Association of Clinical Endocrinologists (AACE). (1)
CL Item
Male or female adults who are between 18-75 years of age at screening (2)
CL Item
Female subjects must be postmenopausal (i.e., > 6 months without menstrual period), surgically sterile, or using effective contraceptive measures (oral contraceptives, Norplant†, Depo-Provera†, an I ntra-Uterine Device (I UD), a diaphragm with spermicide or a condom with spermicide). Subjects suspected of having oligomenorrhea/ amenorrhea due to ovarian hyperandrogenism/ polycyctic ovary syndrome should have a FSH level assessment to determine whether they are postmenopausal. Women of childbearing potential must use effective contraceptive measures for at least 1 month prior to pre-screening (visit 1), and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication. (3)
CL Item
Subject's prior antidiabetic therapy must be one of the following: Subjects previously treated with diet and exercise (drug naïve) and HbA1c > = 7.5 and < = 11% at pre-screening (week –7) (Note: to be considered drug naïve, a subject must have been treated with diet or exercise only or has taken oral antidiabetic medication for less than two weeks within the past 12 weeks); Subjects previously treated with a single oral antidiabetic agent (monotherapy) (for at least 12 weeks prior to pre-screening) and HbA1c > = 7 and < = 10% at prescreening, excluding prior (< 12 weeks from pre-screening) and present thiazolidinedione treatment; Subjects previously treated with combination (maximum of 2 single agents or one non-TZD containing oral combination tablet) oral antidiabetic therapy (for at least 12 weeks prior to pre-screening) (HbA1c > = 6.5 and < = 10% ) excluding prior (< 12 weeks from prescreening) and present thiazolidinedione treatment. (4)
CL Item
Subjects who give their signed informed consent to participate. (5)
exception(s) Inclusion Criteria
Item
Please clarify the exception(s) below:
text
C1705847 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,3])
exclusion criteria
Item
Did the subject meet any of the exclusion criteria?
boolean
C0680251 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
Item
exclusion criteria that disqualified the subject from entry
integer
C0680251 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
CL Item
Any clinically significant abnormality identified at the Screening Visit (Visit 2), physical examination, laboratory tests, or electrocardiogram, which, in the judgement of the I nvestigator, would preclude safe completion of the study. (1)
CL Item
Type 2 diabetic subjects who have required chronic use of insulin for glycemic control in the past 3 months (except during pregnancy or hospitalization), or subjects with history of ketoacidosis. (3)
CL Item
Type 2 diabetic subjects who have required chronic use of insulin for glycemic control in the past 3 months (except during pregnancy or hospitalization), or subjects with history of ketoacidosis. (3)
CL Item
Presence of clinically significant hepatic disease or subjects with ALT > 2.5 times the upper limit of the reference laboratory range. (4)
CL Item
Anemia defined by hemoglobin concentration < 11 g/ dL for males or < 10 g/ dL for females. (5)
CL Item
Subject has a hemoglobinopathy. (6)
CL Item
The subject has a prior history of severe edema or a medically serious fluid related event (e.g., heart failure) associated with any TZD or PPAR- agonist. (7)
CL Item
The subject has significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to TZDs. (8)
CL Item
Subjects who have demonstrated previous glycemic failure on maximal doses of TZDs (i.e., no clinically meaningful decline in HbA1c or FPG during treatment with maximal doses of TZDs). (9)
CL Item
Presence of unstable or severe angina or congestive heart failure (NYHA class I I I / I V). European sites only:Exclude subjects with evidence or history of known congestive heart failure (NYHA class I -I V). (10)
CL Item
Systolic blood pressure > 170mmHg or diastolic blood pressure > 100mmHg while on anti-hypertensive treatment. (11)
CL Item
The subject has a recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months. (12)
CL Item
Women who are lactating, pregnant, or planning to become pregnant. (13)
CL Item
Use of a thiazolidinedione for > 2 weeks within 12 weeks of pre-screening. (14)
CL Item
FPG > 270mg/ dL (15mmol/ L) at screening (Visit 2). (15)
CL Item
The subject has chronic disease requiring periodic or chronic treatment with oral, intravenous, or intra-articular corticosteriods (i.e., chronic use of topical, inhaled, or nasal corticosteroids is permissible). (16)
CL Item
Untreated hypo- or hyperthyroidism. (17)
CL Item
Subjects that have a history of a cancer (other than for successfully treated superficial squamous, basal cell skin cancer, or fully treated cervical cancer in situ) in the past 3 years or are currently receiving treatment for the active cancer. (18)
CL Item
Subjects unwilling or unable to comply with the procedures described in this protocol. (19)
CL Item
Subjects with any history of a gastrointestinal surgical procedure that would affect drug transit time (e.g. cholecystectomy, gastrointestinal bypass surgery, partial or total gastrectomy, small bowel resection). (20)
exception(s) Exclusion Criteria
Item
Please clarify the exception(s) below:
text
C1705847 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
Item Group
Concomitant Medications Prompt
C2347852 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
C0013227 (UMLS CUI-2)
changes concomitant medication
Item
Has there been any changes to the subject's concomitant medication or any new medications taken since the last visit?
boolean
C2347852 (UMLS CUI [1,1])
C2169461 (UMLS CUI [1,2])
C2169461 (UMLS CUI [1,2])
Is the subject continuing in the study?
Item
Is the subject continuing in the study?
boolean
C0805733 (UMLS CUI [1])