Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus

A Randomized, Double-blinded, Placebo-controlled, Crossover Trial to Assess the Effect of Orally Administered LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus

The purpose of the study was to assess the effect of LIK066 on intestinal glucose absorption immediately after a single dose (immediate effect) and 6 hours following the dose (after multiple daily doses; sustained effect) in patients with type 2 diabetes mellitus (T2DM).

Inclusion Criteria:

• Patients, age 18-65 years, must have been diagnosed with T2DM at least 6 months prior to screening with HbA1c 6.5 to 10.0%, inclusive, at screening.
• Fasting plasma glucose ≤250mg/dL at screening.
• If treated with metformin, patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study.

Exclusion Criteria:

• Patients with type 1 diabetes mellitus.
• Patients with history of acute diabetic complications within the 6 months prior to screening.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential unless they are using effective methods of contraception during dosing of study treatment.
• Patients with signs or symptoms of significant diabetic complications.
• Patients treated with certain blood pressure or lipid lowering medications unless patients have been on stable doses for the 12 weeks prior to dosing.
• History of drug or alcohol abuse within the 12 months prior to dosing.
• Any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply