Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Type II Diabetes

In brief

This study is a three part study to assess the safety and efficacy of LEZ763 on normal healthy volunteers and patients with Type 2 Diabetes.

Key facts

Study ID

NCT01619332

Run by

Novartis Pharmaceuticals

People needed

220

Starts

2012-03-01

Expected to finish

2013-09-01

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects: (suggest this will reduce duplication)
• Male or female aged 18-65 yr,
• Subjects must weigh at least 50 kg to participate in the study. Body mass index (BMI) must be within the range of 18-37 kg/m2 (inclusive
• Only postmenopausal females or female subjects who report surgical sterilization (women without child bearing potential) will be allowed in this study.
• Subjects with stable conventional sleep-wake cycle
• Normal Healthy Volunteers
• Healthy male or female subjects,
• must be in good health (as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at Screening).
• Type II Diabetic Patients
• Type 2 diabetes diagnosed by American Diabetes Association criteria for at least 3 months prior to screening.
• Patients either drug naïve or on stable dose of metformin (stable dose for at least 4 weeks prior to Screening). The metformin dose should remain constant during the course of the study.
• HbA1c 6.5 to 9.5 % inclusive at screening

You may not qualify if…

• All subjects:
• Smokers (use of tobacco products in the previous 3 months).
• Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
• Significant illness within two weeks prior to dosing.
• Have (or have history of) drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations
• Normal Healthy Volunteers
• History of diabetes, or adrenal disorders.
• Type II Diabetic Patients
• Type 1 diabetes mellitus; positive anti-GAD antibodies; acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
• Evidence of clinically significant diabetic complications (such nephropathy, retinopathy, neuropathy) Other protocol defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Chula Vista, California, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Cincinnati, Ohio, United States
• Novartis Investigative Site — Knoxville, Tennessee, United States
• Novartis Investigative Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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