Diabetes Mellitus, Non-Insulin-Dependent | Diet therapy | Exercise | Pharmaceutical Preparations naive | Oral hypoglycemic Quantity | Oral hypoglycemic Quantity Combined | rosiglitazone | pioglitazone | Antidiabetics Stable
Item
1. male and female patients with a diagnosis of type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
boolean
C0011860 (UMLS CUI [1])
C0012159 (UMLS CUI [2])
C0015259 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C0919936 (UMLS CUI [4,2])
C0359086 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0359086 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0205195 (UMLS CUI [6,3])
C0289313 (UMLS CUI [7])
C0071097 (UMLS CUI [8])
C0935929 (UMLS CUI [9,1])
C0205360 (UMLS CUI [9,2])
Non-Insulin-Dependent Diabetes Mellitus Duration
Item
2. diagnosis of type 2 diabetes with duration of at least 3 months
boolean
C0011860 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Glycosylated hemoglobin A Percentage
Item
3. glycosylated haemoglobin a1 (hba1c) of:
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Glycosylated hemoglobin A Percentage | Pharmaceutical Preparations naive | Washout Period | Antidiabetics Oral Quantity
Item
7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C1710661 (UMLS CUI [3])
C0935929 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Glycosylated hemoglobin A Percentage Patient Visit
Item
4. hba1c of 7.5%-10.0% at visit 3 (beginning of the 2-week placebo run-in period).
boolean
C0019018 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1512346 (UMLS CUI [1,3])
Age
Item
5. age >=21 and <=75 years.
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
6. bmi (body mass index) >=25.0 and <=40 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Informed Consent
Item
7. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and local legislation
boolean
C0021430 (UMLS CUI [1])
Cardiovascular Diseases | Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
1. clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Alkaline phosphatase raised
Item
2. impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151849 (UMLS CUI [4])
Renal Insufficiency | Impaired renal function | Serum creatinine raised
Item
3. renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
boolean
C1565489 (UMLS CUI [1])
C3807752 (UMLS CUI [2])
C0700225 (UMLS CUI [3])
CNS disorder Interferes with Study Subject Participation Status | Epilepsy | Mental disorders | nervous system disorder | Cerebrovascular Disorders | Polyneuropathy
Item
4. diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
boolean
C0007682 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0014544 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0007820 (UMLS CUI [5])
C0152025 (UMLS CUI [6])
Communicable Diseases | Chronic infectious disease | HIV Infections | Hepatitis
Item
5. chronic or clinically relevant acute infections (e.g., human immunodeficiency virus, hepatitis)
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0019158 (UMLS CUI [4])
Hypersensitivity Interferes with Study Subject Participation Status | Hypersensitivity Investigational New Drug | Hypersensitivity Investigational New Drug Excipient
Item
6. history of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
boolean
C0020517 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013230 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
rosiglitazone | pioglitazone
Item
7. treatment with rosiglitazone or pioglitazone within 6 months prior to screening
boolean
C0289313 (UMLS CUI [1])
C0071097 (UMLS CUI [2])
Insulin regime
Item
8. treatment with insulin within 3 months prior to screening
boolean
C0557978 (UMLS CUI [1])
Substance Use Disorder Interferes with Study Subject Participation Status
Item
9. alcohol or drug abuse within the last 3 months that would interfere with trial participation)
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
10. participation in another trial with an investigational drug within two months prior to administration or during the trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
11. fasting plasma glucose >240 mg/dl (= 13.3 mmol/l) at visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)
boolean
C0583513 (UMLS CUI [1])
Premenopausal | last menstrual period
Item
12. pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:
boolean
C0279752 (UMLS CUI [1])
C0425932 (UMLS CUI [2])
Female Sterilization Missing
Item
1. are not surgically sterile,
boolean
C0015787 (UMLS CUI [1,1])
C1705492 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
2. or are nursing or pregnant;
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Inadequate | transdermal patch | Intrauterine Devices | Contraceptives, Oral | Contraceptive implant | Contraceptive injection | partner had vasectomy | Pregnancy Tests Periodic Disagree
Item
3. or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. no exception will be made.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C2135981 (UMLS CUI [2])
C0021900 (UMLS CUI [3])
C0009905 (UMLS CUI [4])
C1657106 (UMLS CUI [5])
C1656586 (UMLS CUI [6])
C2035056 (UMLS CUI [7])
C0032976 (UMLS CUI [8,1])
C0332182 (UMLS CUI [8,2])
C3641828 (UMLS CUI [8,3])
intolerance to Metformin
Item
13. intolerance of metformin
boolean
C1744706 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])