NCT01619332

Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763 Following Single and Multiple Ascending Doses in Healthy Subjects and Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Type II Diabetes

Interventions

Type	Name	Description
DRUG	Placebo	Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner
DRUG	Sitagliptin	Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner
DRUG	LEZ763	LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-06-14
• Last updated: 2020-12-17

Locations

6 sites across 1 country: United States