Diabetes Mellitus, Type 2Phase 1RESTORENCT00931372
Lixisenatide for Restoration of Insulin Release in Subjects With Diabetes Mellitus Type 2
A Phase 1 study testing Lixisenatide (AVE0010) in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lixisenatide (AVE0010)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 155>=BP systolic >=90 mmHg
- 100>=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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoration of First Phase Insulin Release in Subjects With Type 2 Diabetes Mellitus With Subcutaneous Injection of 20 µg AVE0010 in a Double-blind, Randomized, Placebo-controlled, Two-way Cross Over Intravenous Glucose Challenge Study.
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lixisenatide (AVE0010), Placebo
- Keywords
- Insulin release, Diabetes mellitus type 2, GLP-1 agonist
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lixisenatide (AVE0010)Drug
Solution for subcutaneous injection 100 µg/mL
PlaceboDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: AVE0010/Placebo | Experimental | Period 1: lixisenatide 20 µg in 200 µL, one single dose
Period 2: placebo 200 µL, one single dose Receives: 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 Receives: Drug: Lixisenatide (AVE0010); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the insulin secretion curve
Measured: within 10 minutes after I.V. glucose challenge
Secondary outcomes (1)
Area under the insulin secretion curve
Measured: within 10 to 120 minutes after I.V. glucose challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil GmbH, Neuss, Germany
- Responsible party
- Sponsor
- Investigators
- Christoph KAPITZA, MD, Principal investigator, Profil GmbH, Neuss, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00931372
- Sponsor's protocol ID
- PDY10433
- Other IDs
- EudraCT:2008-003242-28
- Acronym
- RESTORE
- Status last verified
- Feb 2012
- First submitted
- 30 Jun 2009
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of First Phase Insulin Release in Subjects With Type 2 Diabetes Mellitus With Subcutaneous Injection of 20 µg AVE0010 in a Double-blind, Randomized, Placebo-controlled, Two-way Cross Over Intravenous Glucose Challenge Study.
- ClinicalTrials.gov ID
- NCT00931372
- Acronym / sponsor ID
- RESTORE / PDY10433
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Insulin release, Diabetes mellitus type 2, GLP-1 agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Profil GmbH, Neuss, Germany
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: AVE0010/Placebo | Experimental | Drug: Lixisenatide (AVE0010), Drug: PlaceboPeriod 1: lixisenatide 20 µg in 200 µL, one single dose Period 2: placebo 200 µL, one single dose |
| Sequence 2: Placebo/AVE0010 | Experimental | Drug: Lixisenatide (AVE0010), Drug: PlaceboPeriod 1: placebo 200 µL, one single dose Period 2: lixisenatide 20 µg in 200 µL, one single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 155>=BP systolic >=90 mmHg
- 100>=BP diastolic>=45 mmHg
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lixisenatide (AVE0010)Solution for subcutaneous injection 100 µg/mL | Drug | Sequence 1: AVE0010/Placebo, Sequence 2: Placebo/AVE0010 |
| PlaceboSubcutaneous injection | Drug | Sequence 1: AVE0010/Placebo, Sequence 2: Placebo/AVE0010 |
Primary outcome
Area under the insulin secretion curve
Time frame: within 10 minutes after I.V. glucose challenge
1 secondary outcome
Area under the insulin secretion curve
Time frame: within 10 to 120 minutes after I.V. glucose challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph KAPITZA, MD principal investigator
Profil GmbH, Neuss, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lixisenatide (AVE0010) in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the insulin secretion curve (time frame: within 10 minutes after I.V. glucose challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.