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

A Bicentric Open-label, Randomized, Two-parallel-group Study Investigating the Impact of Combined Lantus Insulin Glargine) and Lyxumia(Lixisenatide) on Insulin Secretion and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled on Diet and Oral Antidiabetic Medication

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01910194
Enrollment
39
Registered
2013-07-29
Start date
2013-12-31
Completion date
2014-10-31
Last updated
2015-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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

Interventions

DRUGLuyxumia versus Lantus

Sponsors

Sanofi
CollaboratorINDUSTRY
Profil Institut für Stoffwechselforschung GmbH
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
AUCISEC(0-10min)Within 0 to 10 min after iv glucose challenge

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026