Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients must have a documented diagnosis of Type 2 diabetes confirmed by World Health Organization (WHO) criteria either a FPG≥ 7.0 mmol/l (126 mg/dl) or an Oral glucose tolerance test (OGTT) test 2-hour PG ≥ 11.1 mmol/l (200 mg/dl).
2. Patients must:
* be naïve to anti-diabetes drug therapy (except for short term treatment courses with insulin in connection with hospitalization, etc.)
* be on stable metformin monotherapy treatment for at least three months at Screening
* meet protocol specified HbA1c criteria
* take metformin as their first and only treatment with anti-diabetes drug therapy OR
* be taking an AGI as their first and only anti-diabetes drug therapy (except short term treatment courses with insulin in connection with hospitalizations, etc)
* meet protocol specified HbA1c criteria
* be eligible for metformin monotherapy
3. Patients must have a morning fasting plasma glucose result \< 180 mg/dl at Visit 3 (Month -1) analyzed by the Central Laboratory.
4. Were on a daily dose of metformin ≥ 1000 mg (or less according to local regulations)
You may not be if
1. Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes.
2. Any of the following significant laboratory abnormalities:
* Clinically significant Thyroid stimulating hormone (TSH) outside of normal range at Screening
* Renal function indicating high risk metformin use, including serum creatinine concentrations (≥1.5 mg/dL for males, ≥1.4 mg/dL for females) or other evidence of abnormal creatinine clearance.
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN), or total bilirubin \> 2 x ULN and/or direct bilirubin \> ULN at Screening, confirmed with repeat measure within one week.
3. History or current findings of active pulmonary disease as evidenced by a history of positive purified protein derivative (PPD), QuantiFERON-TB Gold (QFT-G), AFB sputum or positive PPD followed by positive chest x-ray or QFT-G, or ongoing antibiotic treatment for latent TB.
4. Risk factors for TB as defined in protocol
5. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven or suspected to be related to immunocompromise including HIV or active or recurrent Hepatitis B and Hepatitis C.
6. Systemic or local treatment of any immune modulating agent in doses with systemic effects or live vaccinations within 3 months
7. Stroke, myocardial infarction, acute coronary syndrome, revascularization procedure or recurrent TIA within the last 6 months.
8. Unwillingness to use insulin glargine as the additional medication should glycemic control deteriorate.
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