Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diagnosis of type 2 diabetes mellitus.
boolean
C0011860 (UMLS CUI [1])
Metformin Dose Frequency | Antidiabetics Quantity
Item
2. current treatment with metformin alone (>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. metformin must be administered in twice daily dosing regimen. patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained.
boolean
C0025598 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439603 (UMLS CUI [1,3])
C0935929 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Glucohemoglobin measurement
Item
3. glycosylated haemoglobin (hba1c) is between 7.0% - 10.0%.
boolean
C0202054 (UMLS CUI [1])
Body mass index
Item
4. body mass index (bmi) </=45 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Metformin Extended Release
Item
1. treatment with extended release metformin.
boolean
C0025598 (UMLS CUI [1,1])
C1707968 (UMLS CUI [1,2])
Hyperglycemia Uncontrolled | Plasma fasting glucose measurement
Item
2. uncontrolled hyperglycaemia (fasting plasma glucose > 240 mg/dl or 13.3 mmol/l).
boolean
C0020456 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0583513 (UMLS CUI [2])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
3. myocardial infarction (mi), stroke or transient ischaemic attack (tia) within 6 months prior to informed consent.
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Liver Dysfunction | Renal Insufficiency | Gastric Bypass
Item
4. impaired hepatic or renal function, or gastric bypass surgery.
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0017125 (UMLS CUI [3])
Thiazolidinediones | GLP-1 Mimetics | Anti-Obesity Agents | Insulin
Item
5. treatment with glitazones, glucagon like peptide-1 (glp-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent.
boolean
C1257987 (UMLS CUI [1])
C3273809 (UMLS CUI [2])
C0376607 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
Systemic steroids | Thyroid Hormones Dosage Change
Item
6. current treatment with systemic steroids or change in dosage of thyroid hormones.
boolean
C2825233 (UMLS CUI [1])
C0040135 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
Substance Use Disorders
Item
7. alcohol or drug abuse within 3 months of informed consent.
boolean
C0038586 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
8. participation in another trial with investigational drug within 2 months prior to informed consent.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Premenopausal state | Breast Feeding | Pregnancy | Contraceptive methods Absent
Item
9. pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.
boolean
C0232969 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])