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Safety and Tolerability of Lixisenatide in Combination With Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

NCT01940965 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2015-08-04

No results posted yet for this study

Summary

Primary Objective:

The primary objective of this study is to assess the overall safety of lixisenatide once daily treatment in combination with background oral anti-diabetic treatment over 52 weeks in patients with type 2 diabetes in Japan.

Secondary Objective:

To assess the effects of lixisenatide in combination with background oral antidiabetic drug (OAD) on:

* HbA1c;
* Fasting plasma glucose;
* Body weight.

Conditions

Interventions

DRUG

lixisenatide AVE0010

Pharmaceutical form:solution Route of administration: Subcutaneous injection

DRUG

biguanide

Pharmaceutical form:tablet Route of administration: oral

DRUG

TZD

Pharmaceutical form:tablet Route of administration: oral

DRUG

alpha-GI

Pharmaceutical form:tablet Route of administration: oral

DRUG

glinide

Pharmaceutical form:tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
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 NCT01940965 on ClinicalTrials.gov