NCT00931372

Brief Summary

The objective of this study is to test whether Lixisenatide (AVE0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

June 30, 2009

Last Update Submit

February 22, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Insulin releaseDiabetes mellitus type 2GLP-1 agonist

Outcome Measures

Primary Outcomes (1)

  • Area under the insulin secretion curve

    within 10 minutes after I.V. glucose challenge

Secondary Outcomes (1)

  • Area under the insulin secretion curve

    within 10 to 120 minutes after I.V. glucose challenge

Study Arms (2)

Sequence 1: AVE0010/Placebo

EXPERIMENTAL

Period 1: lixisenatide 20 µg in 200 µL, one single dose Period 2: placebo 200 µL, one single dose

Drug: Lixisenatide (AVE0010)Drug: Placebo

Sequence 2: Placebo/AVE0010

EXPERIMENTAL

Period 1: placebo 200 µL, one single dose Period 2: lixisenatide 20 µg in 200 µL, one single dose

Drug: Lixisenatide (AVE0010)Drug: Placebo

Interventions

Lixisenatide (AVE0010)DRUG

Solution for subcutaneous injection 100 µg/mL

Sequence 1: AVE0010/PlaceboSequence 2: Placebo/AVE0010
PlaceboDRUG

Subcutaneous injection

Sequence 1: AVE0010/PlaceboSequence 2: Placebo/AVE0010

Eligibility Criteria

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

You may qualify if:

  • Male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin
  • HbA1c\>=6,0 % and \<=8,5 % at screening
  • BMI 25 to 35 kg/m²
  • \>=BP systolic \>=90 mmHg
  • \>=BP diastolic\>=45 mmHg
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Berlin, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Christoph KAPITZA, MD

    Profil GmbH, Neuss, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations

DE(1)