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Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

NCT01175473 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2016-11-28

Study results available
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Summary

The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment.

The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at Week 4.

The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY \[PYY3-36\] and oxyntomodulin); and to assess the clinical and laboratory safety profile.

Conditions

Interventions

DRUG

Lixisenatide (AVE0010)

Self administered by subcutaneous injections once daily 30 minutes before breakfast.

DEVICE

Pen auto-injector

DRUG

Liraglutide

Self administered by subcutaneous injections once daily 30 minutes before breakfast.

DEVICE

Pre-filled pen injector

DRUG

Metformin

Metformin to be continued at stable dose (1.5 gram per day) up to Week 4.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT01175473 on ClinicalTrials.gov