Type 2 Diabetes MellitusPhase 3NCT01960179
Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
A Phase 3 study testing lixisenatide AVE0010 in people with Type 2 Diabetes Mellitus, run by Sanofi at 30 sites in Japan.
Trial summary
Primary Objective: To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan Secondary Objective: To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on: HbA1c (Glycated hemoglobin A1c)… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- lixisenatide AVE0010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 30 sitesJapan
- Study dates
- Nov 2013to Mar 2015
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus diagnosed for at least 2 months.
- Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 to be washed out during the run-in period at least for 6 weeks;
- Signed written informed consent.
Who cannot join
- At screening
- age <20 years;
- HbA1c <7% or >9.5% (for patients on OAD <6.5% or >8.5%);
- fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
- Use of more than one OAD within 3 months prior to screening;
- Use of Thiazolidinedione (TZD) within 6 months prior to screening;
Show all 20Show fewer
- Use of insulin within 3 months prior to screening; Note: Short time use (≤10 days) of insulin due to acute illness or surgery (eg, infectious disease) is allowed.
- Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP-1 receptor agonist;
- Type 1 diabetes mellitus
- Women of childbearing potential with no effective contraceptive method;
- Pregnancy or lactation;
- Laboratory findings at the time of screening:
- oAmylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN);
- ALT >3 ULN;
- Calcitonin ≥20 pg/mL (5.9 pmol/L);
- Positive serum pregnancy test in women of childbearing potential;
- History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
- Allergic reaction to metacresol.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Japan30 sites
Investigational Site Number 392006
Adachi-Ku
Investigational Site Number 392005
Chiba
Investigational Site Number 392010
Chiyoda-Ku
Investigational Site Number 392003
Chuoh-Ku
Investigational Site Number 392004
Chūōku
Investigational Site Number 392015
Chūōku
Investigational Site Number 392012
Ebina-Shi
Investigational Site Number 392024
Higashiosaka-Shi
Investigational Site Number 392023
Kashiwara-Shi
Investigational Site Number 392008
Kawagoe-Shi
Investigational Site Number 392009
Kisarazu-Shi
Investigational Site Number 392002
Koganeishi
Investigational Site Number 392007
Koriyama-Shi
Investigational Site Number 392011
Mitaka-Shi
Investigational Site Number 392025
Nagoya
Investigational Site Number 392026
Nagoya
Investigational Site Number 392013
Ogawa-Machi, Hikigun
Investigational Site Number 392014
Ohta-Ku
Investigational Site Number 392022
Okawa-Shi
Investigational Site Number 392021
Osaka
Investigational Site Number 392028
Osaka
Investigational Site Number 392029
Osaka
Investigational Site Number 392030
Sapporo
Investigational Site Number 392018
Sendai
Investigational Site Number 392001
Shinjuku-Ku
Investigational Site Number 392020
Suita-Shi
Investigational Site Number 392017
Toshima-Ku
Investigational Site Number 392027
Toyonaka-Shi
Investigational Site Number 392016
Yokohama
Investigational Site Number 392019
Yokohama
About this study
Official title: An Open-label, Multicenter 24-Week And 52-Week Study Assessing The Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
Primary Objective:
To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan
Secondary Objective:
To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on:
- HbA1c (Glycated hemoglobin A1c) reduction;
- Fasting plasma glucose;
- Body weight.
Read the detailed description
- Group 1: 60 weeks ± 11 days
- Group 2: 32 weeks ± 7 days
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- lixisenatide AVE0010
- 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 AVE0010Drug
Pharmaceutical form:solution Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| lixisenatide | Experimental | lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment) Receives: Drug: lixisenatide AVE0010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.
Measured: from baseline to 24 weeks and 52 weeks
Secondary outcomes (3)
Absolute change in HbA1c
Measured: from baseline to week 24 and week 52
Absolute change in fasting plasma glucose
Measured: from baseline to week 24 and week 52
Absolute change in body weight
Measured: from baseline to week 24 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960179
- Sponsor's protocol ID
- SFY13476
- Other IDs
- U1111-1134-2695
- Status last verified
- Apr 2015
- First submitted
- 27 Sep 2013
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter 24-Week And 52-Week Study Assessing The Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01960179
- Acronym / sponsor ID
- SFY13476
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 10 Oct 2013 (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.
Primary Objective:
To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan
Secondary Objective:
To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on:
- HbA1c (Glycated hemoglobin A1c) reduction;
- Fasting plasma glucose;
- Body weight.
Detailed description
- Group 1: 60 weeks ± 11 days
- Group 2: 32 weeks ± 7 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lixisenatide | Experimental | Drug: lixisenatide AVE0010lixisenatide monotherapy by group (Group 1: 52-week treatment; Group 2: 24-week treatment) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus diagnosed for at least 2 months.
- Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 to be washed out during the run-in period at least for 6 weeks;
- Signed written informed consent.
Key exclusion criteria (20 listed)
- At screening
- age <20 years;
- HbA1c <7% or >9.5% (for patients on OAD <6.5% or >8.5%);
- fasting plasma glucose >250 mg/dL (>13.9 mmol/L);
- Use of more than one OAD within 3 months prior to screening;
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 AVE0010Pharmaceutical form:solution Route of administration: Subcutaneous injection | Drug | lixisenatide |
Primary outcome
Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data.
Time frame: from baseline to 24 weeks and 52 weeks
3 secondary outcomes
Absolute change in HbA1c
Time frame: from baseline to week 24 and week 52
Absolute change in fasting plasma glucose
Time frame: from baseline to week 24 and week 52
Absolute change in body weight
Time frame: from baseline to week 24 and week 52
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 9 Apr 2015.
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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.
Clinical Sciences & Operations study director
Sanofi
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lixisenatide AVE0010 in people with Type 2 Diabetes Mellitus, run by Sanofi at 30 sites in Japan.
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 3 inclusion and 20 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 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Safety over 24 and 52 weeks assessed by treatment emergent adverse event (TEAE), vital signs, 12-lead electrocardiogram (ECG), and laboratory data. (time frame: from baseline to 24 weeks and 52 weeks). 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 9 Apr 2015.