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

NCT02200991 · Completed

Last updated 2026-05-28

This clinical trial tested the effects of the medication lixisenatide compared to sitagliptin, both added to insulin glargine, in adults with type 2 diabetes to see how they influenced blood sugar levels after a meal.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 136 people

Who can join Ages 20–75 · all sexes

Timeline Started 2014-08 · est. completion 2015-11

Where 20 sites · Japan

What this study is testing ClinicalTrials.gov NCT02200991 ↗

Description as written by the study sponsor.

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

Treatments tested

LIXISENATIDE AVE0010 Drug

Pharmaceutical form:solution Route of administration: subcutaneous
Sitagliptin also known as Januvia Drug

Pharmaceutical form:tablet Route of administration: oral
Insulin glargine HOE901 also known as Lantus Drug

Pharmaceutical form:solution Route of administration: subcutaneous

Main thing measured	Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
Sponsor	Sanofi
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02200991 ↗