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Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

NCT01619332 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2020-12-17

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01619332 on ClinicalTrials.gov