Impact of Combined of Lantus(Insulin Glargine) and Lyxumi... | NCT01910194

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

NCT01910194

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Status

Completed

Last Update Posted

Jan 22, 2015Estimated

Enrollment

39Actual

Phase

Phase 2

Conditions

Diabetes Mellitus

Interventions

Luyxumia versus Lantus

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jul 25, 2013

First Submission Date that Met QC Criteria

Jul 25, 2013

First Posted Date

Jul 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2015

Last Update Posted Date

Jan 22, 2015Estimated

Name	Class
Sanofi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Luyxumia versus Lantus	Drug		Lantus Lyxumia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUCISEC(0-10min)		Within 0 to 10 min after iv glucose challenge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Josef-Hospital, University Hospital, Ruhr		Bochum		44791	Germany
Profil Institut für Stoffwechselforschung GmbH

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided