Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Luyxumia versus Lantus

• Registration Number: NCT01910194
• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH

Brief Summary

Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Detailed Description

Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Study Timeline

• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-29
• Study Start: 2013-12
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-21
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists
• Inadequately controlled diabetes mellitus

Exclusion Criteria

• Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lantus	Luyxumia versus Lantus	4 weeks Lantus plus another 4 weeks combination
Lyxumia	Luyxumia versus Lantus	4 weeks Luxumia plus another 4 weeks combination

Primary Outcome Measures

Name	Time	Method
AUCISEC(0-10min)	Within 0 to 10 min after iv glucose challenge

Trial Locations

Locations (2)

St. Josef-Hospital, University Hospital, Ruhr; 🇩🇪 Bochum, Germany

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany