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

Information source: Profil Institut fr Stoffwechselforschung GmbH
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus

Intervention: Luyxumia versus Lantus (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Profil Institut fr Stoffwechselforschung GmbH

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: AUCISEC(0-10min)

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

St. Josef-Hospital, University Hospital, Ruhr, Bochum 44791, Germany

Profil Institut für Stoffwechselforschung GmbH, Neuss 41460, Germany

Additional Information

Starting date: December 2013
Last updated: January 21, 2015

Page last updated: August 23, 2015

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