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Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

NCT02200991 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-10-05

No results posted yet for this study

Summary

Primary Objective:

To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29.

Secondary Objectives:

To demonstrate:

* Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast
* Delaying gastric emptying (13C-acetic acid breath test)
* Safety and tolerability

Conditions

Interventions

DRUG

LIXISENATIDE AVE0010

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

Sitagliptin

Pharmaceutical form:tablet Route of administration: oral

DRUG

Insulin glargine HOE901

Pharmaceutical form:solution Route of administration: subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-11-30
Completion
2015-11-30

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 NCT02200991 on ClinicalTrials.gov