A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and
normoglycemic patients with elevated body mass index (BMI)
- Subjects with stable health condition as determined by past medical history, physical
examination, electrocardiogram, and laboratory tests at screening.
- Patients with dysglycemia are patients with: Fasting plasma glucose >100mg/dL (5.6
mmol/L), or HbA1c > 5.7% and < 10% at screening.
- Fasting plasma glucose ≤250mg/dL (13.9 mmol/L) at screening.
- If treated with antidiabetic medications (other than prohibited medications),
patients must be on a stable dose for 12 weeks prior to randomization and maintain
the dose until the end of the study.
- Subjects must have a body mass index (BMI) within the range of 35 - 50 kg/m2 at
screening, with stable body weight (± 5 kg) within 3 months prior to screening
- Pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal
or other chronic medical condition which is considered serious or unstable, other
than stable cardiovascular disease, treated hypertension, dyslipidemia or other
stable chronic disorders
- Clinically significant GI disorder related to malabsorption or that may affect drug
or glucose absorption or history of significant gastrointestinal surgery that could
affect intestinal glucose absorption
- Enrollment in a diet, weight loss or exercise programs with the specific intent of
losing weight, within 3 months prior to randomization, or clinical diagnosis of any
- Pregnant or nursing (lactating) women, and women of child-bearing potential
Other inclusion/exclusion criteria may apply