ID

15993

Beschreibung

Dose-finding Study of LIK066 Compared With Placebo or Sitagliptin to Evaluate Change in HbA1c in Patients With Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01824264

Link

https://clinicaltrials.gov/show/NCT01824264

Stichworte

Versionen (2)
  1. 25.06.16 25.06.16 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

25. Juni 2016

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01824264

Englisch

Eligibility Type 2 Diabetes Mellitus NCT01824264

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. confirmed diagnosis of t2dm by standard criteria
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
2. drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
Beschreibung

Therapy naive | Antidiabetics

Datentyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2]
C0935929
3. currently untreated patients , who, after the diagnosis of t2dm, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to visit 1
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent Antidiabetics | Diabetes Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0935929
UMLS CUI [2]
C3274787
4. patients being treated with mono-therapy for at least 8 consecutive weeks prior to visit 1 with the following oads: metformin, dipeptidyl peptidase-4 inhibitors (dpp-4i), su, glinide, alpha-glucosidase inhibitor (agi)
Beschreibung

Therapeutic procedure Antidiabetics Oral | Metformin | Dipeptidyl Peptidase 4 Inhibitors | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0935929
UMLS CUI [1,3]
C1527415
UMLS CUI [2]
C0025598
UMLS CUI [3]
C2917254
UMLS CUI [4]
C0038766
UMLS CUI [5]
C2266929
UMLS CUI [6]
C1299007
5. hba1c ≥ 7 to ≤ 10.5% at visit 1 for drug-naïve/currently untreated patients
Beschreibung

Glycosylated hemoglobin A Therapy naive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0919936
6. hba1c ≥ 7 to ≤ 9.5% at visit 1 for patients treated with oad monotherapy
Beschreibung

Glycosylated hemoglobin A Therapeutic procedure Antidiabetics Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0935929
UMLS CUI [1,4]
C1527415
7. hba1c ≥ 7 to ≤ 10.5% at visit 199 for all patients
Beschreibung

Glycosylated hemoglobin A Patients All

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019018
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0444868
8. age: ≥18 and ≤ 75 years old at visit 1
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
9. bmi ≥22 to ≤45 kg/m2 at visit 1
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. fpg ≥270 mg/dl (15 mmol/l) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/l) for patients on oad monotherapy at visit 1
Beschreibung

Plasma fasting glucose measurement Therapy naive | Plasma fasting glucose measurement Therapeutic procedure Antidiabetics Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0583513
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0583513
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0935929
UMLS CUI [2,4]
C1527415
2. insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
Beschreibung

Insulin regime | corticosteroid use | Growth Hormone Use | weight control agent Use

Datentyp

boolean

Alias
UMLS CUI [1]
C0557978
UMLS CUI [2]
C0239126
UMLS CUI [3,1]
C0037663
UMLS CUI [3,2]
C1524063
UMLS CUI [4,1]
C0597686
UMLS CUI [4,2]
C1524063
3. history of acute metabolic complications, cv disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
Beschreibung

Acute metabolic disorder | Cardiovascular Diseases | Diabetes Mellitus, Insulin-Dependent | Liver diseases | Pancreatitis | Chronic diarrhea

Datentyp

boolean

Alias
UMLS CUI [1]
C1290840
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0011854
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0030305
UMLS CUI [6]
C0401151
4. significant lab abnormalities such as tsh outside of normal range, uacr>300 mg/g creatinine, egfr <60 ml/min/1.73m2, hemoglobin <12 g/l in men and <11 g/l in women, hematuria
Beschreibung

Laboratory test result abnormal Significant | Thyroid stimulating hormone measurement Abnormal | Urine albumin/creatinine ratio measurement Creatinine measurement | Estimated Glomerular Filtration Rate | Hemoglobin measurement Gender | Hematuria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C0202230
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0455271
UMLS CUI [3,2]
C0201975
UMLS CUI [4]
C3811844
UMLS CUI [5,1]
C0518015
UMLS CUI [5,2]
C0079399
UMLS CUI [6]
C0018965
5. ecg abnormalities including av block, long qt syndrome or qtc>450 msec for men and >470 msec for women
Beschreibung

ECG abnormality | Atrioventricular Block | Long QT Syndrome | QTc Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C1832603
UMLS CUI [2]
C0004245
UMLS CUI [3]
C0023976
UMLS CUI [4,1]
C0860814
UMLS CUI [4,2]
C0079399
6. history of malignancy
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
7. women of child-bearing potential not using effective methods of contraception other protocol-defined inclusion/exclusion criteria may apply
Beschreibung

Childbearing Potential Contraceptive methods Not used

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0445107
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus NCT01824264

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
1. confirmed diagnosis of t2dm by standard criteria
boolean
C0011860 (UMLS CUI [1])
Therapy naive | Antidiabetics
Item
2. drug-naïve patients, defined as patients not having received any anti-diabetic medication previously,
boolean
C0919936 (UMLS CUI [1])
C0935929 (UMLS CUI [2])
Diabetes Mellitus, Non-Insulin-Dependent Antidiabetics | Diabetes Therapy
Item
3. currently untreated patients , who, after the diagnosis of t2dm, have received anti-diabetic medication for not more than 12 consecutive weeks, and have not received any anti-diabetic treatment within 12 weeks prior to visit 1
boolean
C0011860 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C3274787 (UMLS CUI [2])
Therapeutic procedure Antidiabetics Oral | Metformin | Dipeptidyl Peptidase 4 Inhibitors | Sulfonylurea | Glinide | alpha-Glucosidase Inhibitors
Item
4. patients being treated with mono-therapy for at least 8 consecutive weeks prior to visit 1 with the following oads: metformin, dipeptidyl peptidase-4 inhibitors (dpp-4i), su, glinide, alpha-glucosidase inhibitor (agi)
boolean
C0087111 (UMLS CUI [1,1])
C0935929 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C0025598 (UMLS CUI [2])
C2917254 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C2266929 (UMLS CUI [5])
C1299007 (UMLS CUI [6])
Glycosylated hemoglobin A Therapy naive
Item
5. hba1c ≥ 7 to ≤ 10.5% at visit 1 for drug-naïve/currently untreated patients
boolean
C0019018 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Glycosylated hemoglobin A Therapeutic procedure Antidiabetics Oral
Item
6. hba1c ≥ 7 to ≤ 9.5% at visit 1 for patients treated with oad monotherapy
boolean
C0019018 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0935929 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
Glycosylated hemoglobin A Patients All
Item
7. hba1c ≥ 7 to ≤ 10.5% at visit 199 for all patients
boolean
C0019018 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Age
Item
8. age: ≥18 and ≤ 75 years old at visit 1
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
9. bmi ≥22 to ≤45 kg/m2 at visit 1
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Plasma fasting glucose measurement Therapy naive | Plasma fasting glucose measurement Therapeutic procedure Antidiabetics Oral
Item
1. fpg ≥270 mg/dl (15 mmol/l) for drug-naïve/currently untreated patients or ≥240 mg/dl (13.3 mmol/l) for patients on oad monotherapy at visit 1
boolean
C0583513 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0583513 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0935929 (UMLS CUI [2,3])
C1527415 (UMLS CUI [2,4])
Insulin regime | corticosteroid use | Growth Hormone Use | weight control agent Use
Item
2. insulin treatment >4 consecutive weeks in the last 6 months, corticosteroid use >7 days in the last 8 weeks, use of growth hormones in the last 6 months, or use of weight control products > 4 weeks in the last 6 months
boolean
C0557978 (UMLS CUI [1])
C0239126 (UMLS CUI [2])
C0037663 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0597686 (UMLS CUI [4,1])
C1524063 (UMLS CUI [4,2])
Acute metabolic disorder | Cardiovascular Diseases | Diabetes Mellitus, Insulin-Dependent | Liver diseases | Pancreatitis | Chronic diarrhea
Item
3. history of acute metabolic complications, cv disease, type 1 diabetes mellitus, hepatic disorders, pancreatitis, chronic diarrhea
boolean
C1290840 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0030305 (UMLS CUI [5])
C0401151 (UMLS CUI [6])
Laboratory test result abnormal Significant | Thyroid stimulating hormone measurement Abnormal | Urine albumin/creatinine ratio measurement Creatinine measurement | Estimated Glomerular Filtration Rate | Hemoglobin measurement Gender | Hematuria
Item
4. significant lab abnormalities such as tsh outside of normal range, uacr>300 mg/g creatinine, egfr <60 ml/min/1.73m2, hemoglobin <12 g/l in men and <11 g/l in women, hematuria
boolean
C0438215 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0202230 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0455271 (UMLS CUI [3,1])
C0201975 (UMLS CUI [3,2])
C3811844 (UMLS CUI [4])
C0518015 (UMLS CUI [5,1])
C0079399 (UMLS CUI [5,2])
C0018965 (UMLS CUI [6])
ECG abnormality | Atrioventricular Block | Long QT Syndrome | QTc Gender
Item
5. ecg abnormalities including av block, long qt syndrome or qtc>450 msec for men and >470 msec for women
boolean
C1832603 (UMLS CUI [1])
C0004245 (UMLS CUI [2])
C0023976 (UMLS CUI [3])
C0860814 (UMLS CUI [4,1])
C0079399 (UMLS CUI [4,2])
Malignant Neoplasms
Item
6. history of malignancy
boolean
C0006826 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Not used
Item
7. women of child-bearing potential not using effective methods of contraception other protocol-defined inclusion/exclusion criteria may apply
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0445107 (UMLS CUI [1,3])
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