NCT01910194

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 diabetes-mellitus

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_2 diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

July 25, 2013

Last Update Submit

January 21, 2015

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • AUCISEC(0-10min)

    Within 0 to 10 min after iv glucose challenge

Study Arms (2)

Lyxumia

OTHER

4 weeks Luxumia plus another 4 weeks combination

Drug: Luyxumia versus Lantus

Lantus

OTHER

4 weeks Lantus plus another 4 weeks combination

Drug: Luyxumia versus Lantus

Interventions

Luyxumia versus LantusDRUG
LantusLyxumia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Josef-Hospital, University Hospital, Ruhr

Bochum, 44791, Germany

Location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 29, 2013

Study Start

December 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

DE(2)