Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

ClinicalTrials.gov ID: NCT01619332

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01619332
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 220 participants

Conditions and interventions

Conditions

Type II Diabetes

Interventions

Placebo Drug
Sitagliptin Drug
LEZ763 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 2012 (Type not available)
Primary completion: Sep 2013 (Actual)
Completion: Sep 2013 (Actual)
Last update posted: Dec 17, 2020

2012 – 2013

United States locations

U.S. sites: 6
U.S. states: 5
U.S. cities: 6

Facility	City	State	ZIP	Site status
Novartis Investigative Site	Chula Vista	California	91910	—
Novartis Investigative Site	Miami	Florida	33126	—
Novartis Investigative Site	Orlando	Florida	32809	—
Novartis Investigative Site	Cincinnati	Ohio	45227	—
Novartis Investigative Site	Knoxville	Tennessee	37920	—
Novartis Investigative Site	San Antonio	Texas	78209	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01619332, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 17, 2020 · Synced Nov 14, 2026