Patients will be excluded if they have had exposure to a total daily dose of MET 1000 mg bid for at least 2 weeks in the past 3 months;
Patients will be excluded if they could not tolerate MET during the recommended titration schedule outlined in the protocol;
Major neurological or medical illnesses that affect weight gain (e.g., unstable thyroid disease) or require a systemic medication that might impact weight or glucose regulation (e.g., diabetes mellitus [insulin], chronic renal failure [steroids]);
Fasting glucose = 126 mg/dL on 2 occasions during screening indicating need for prompt treatment;
If lab results are available in the last 6 months, then a serum creatinine =1.3 mg/dL on 2 occasions during screening and/or follow-up, indicating potential impairment of renal functioning;
Pregnant or breast feeding;
Children and caregivers who are unable to complete assessments for any reason;

NCT02515773_exc_T1
Drug
MET
NCT02515773_exc_T2
Multiplier
1000 mg bid
NCT02515773_exc_T3
Temporal
at least 2 weeks in the past 3 months
NCT02515773_exc_T4
Condition
not tolerate
NCT02515773_exc_T5
Drug
MET
NCT02515773_exc_T6
Condition
thyroid disease
NCT02515773_exc_T7
Qualifier
unstable
NCT02515773_exc_T8
Condition
diabetes mellitus
NCT02515773_exc_T9
Drug
insulin
NCT02515773_exc_T10
Condition
chronic renal failure
NCT02515773_exc_T11
Drug
steroids
NCT02515773_exc_T12
Measurement
Fasting glucose
NCT02515773_exc_T13
Value
= 126 mg/dL
NCT02515773_exc_T14
Multiplier
2 o
NCT02515773_exc_T15
Measurement
serum creatinine
NCT02515773_exc_T16
Value
=1.3 mg/dL
NCT02515773_exc_T17
Multiplier
2