Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1

NCT01146678 · Completed

Last updated 2026-05-28

This clinical trial is testing different versions of insulin glargine and lixisenatide in people who have type 1 diabetes to see how the body absorbs and processes them.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

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

Participants 22 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2010-06 · est. completion 2011-01

Where 1 site · Germany

What this study is testing ClinicalTrials.gov NCT01146678 ↗

Description as written by the study sponsor.

Primary Objective: * to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: * to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug * to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix

Treatments tested

Insulin glargine HOE901 Drug

Pharmaceutical form:solution for injection Route of administration: subcutaneous
Lixisenatide AVE0010 Drug

Pharmaceutical form:solution for injection Route of administration: subcutaneous

Main thing measured	Area under the plasma lixisenatide concentration curve (LIX-AUClast)
Sponsor	Sanofi
Conditions studied	Type 1 Diabetes Mellitus
GLP-1 drugs	lixisenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01146678 ↗