Effect of LIK066 on Glucose Absorption in Patients With Type 2 Diabetes Mellitus
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 5/3/2014 |
Start Date: | July 2013 |
End Date: | December 2013 |
Contact: | Novartis Pharmaceuticals |
Phone: | 1-888-669-6682 |
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 is 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).
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
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