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Trial record 48 of 61 for:    Lixisenatide

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

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ClinicalTrials.gov Identifier: NCT01910194
Recruitment Status : Completed
First Posted : July 29, 2013
Last Update Posted : January 22, 2015
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Luyxumia versus Lantus Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Start Date : December 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Lyxumia
4 weeks Luxumia plus another 4 weeks combination
Drug: Luyxumia versus Lantus
Lantus
4 weeks Lantus plus another 4 weeks combination
Drug: Luyxumia versus Lantus



Primary Outcome Measures :
  1. AUCISEC(0-10min) [ Time Frame: Within 0 to 10 min after iv glucose challenge ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910194


Locations
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Germany
St. Josef-Hospital, University Hospital, Ruhr
Bochum, Germany, 44791
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Sanofi

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Responsible Party: Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier: NCT01910194     History of Changes
Other Study ID Numbers: LanLyx
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Glargine
Lixisenatide
Hypoglycemic Agents
Physiological Effects of Drugs