Expired Study
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Lincoln, Nebraska 68502


Purpose:

A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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 eating disorder - Pregnant or nursing (lactating) women, and women of child-bearing potential Other inclusion/exclusion criteria may apply


NCT ID:

NCT02470403


Primary Contact:

Study Director
Study Director
Novartis Pharmaceuticals


Backup Contact:

N/A


Location Contact:

Lincoln, Nebraska 68502
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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