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

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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).


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
We found this trial at
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Chula Vista, California 91910
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Chula Vista, CA
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