Type II Diabetes MellitusPhase 2NCT02274740
Effect of Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
A Phase 2 study testing LIXISENATIDE AVE0010 and metformin in people with Type II Diabetes Mellitus, run by Sanofi.
Trial summary
Primary Objective: To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides. Secondary Objectives: The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- LIXISENATIDE AVE0010 and metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2015
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, 18-70 years of age.
- Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index [BMI] >30 kg/m^2) and the following other abnormalities:
- Abdominal obesity (waist circumference >102 cm in men and >88 cm in women). According to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001).
- Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might reasonably suggest more stringent A1c goals [such as 6.5%] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease).
- Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL, cholesterol <300 mg/dL. In order to exclude patients who might be suffering from a primitive dyslipidemia).
- Low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <40 mg/dL in men and <50 mg/dL in women).
- Written informed consent.
Who cannot join
- Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (Thyroid Stimulating Hormone [TSH] >5 mU/L with clinical symptoms of hypothyroidism).
- Hepatic disease (Aspartate Aminotransferase [ASAT] or Alanine Aminotransferase [ALAT] >2 times the upper limit of normal).
- Renal disease (serum creatinine >1.7 times the upper limit of normal). A history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment.
- History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg. Triglycerides >600 mg/dL. History of chronic pancreatitis or of idiopathic acute pancreatitis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
Primary Objective:
To evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides.
Secondary Objectives:
The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation.
The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity.
The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.
Read the detailed description
Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (Final/End-of-treatment Visit).
- Conditions
- Type II Diabetes Mellitus
- Being tested
- LIXISENATIDE AVE0010, metformin
- 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
metforminDrug
Pharmaceutical form:tablet Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| lixisenatide | Experimental | Lixisenatide injection should be performed in the morning, within 1 hour (ie, 0-60 minutes), prior to breakfast (or standardized meal).
Lixisenatide is to be started with once daily injections of 10 μg per day for 2 weeks then to be continued by the maintenance dose (8 weeks) of 20 μg/d up to the end of the treatment period. Receives: Drug: LIXISENATIDE AVE0010; Drug: metformin |
| metformin | No intervention | Greater than or equal than 1.5 g/day as background therapy for 10 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)
Measured: After 10 weeks of treatment
Secondary outcomes (11)
Change from baseline in plasma triglyceride
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in plasma cholesterol
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in APO B48
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in free fatty acid levels
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in lipoprotein distribution
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in LDL oxidation
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in postprandial plasma glucose
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in insulin
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in C-peptide
Measured: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in low grade inflammation (cytokines and stress oxidative markers)
Measured: 2 days after the basal test and after 10 weeks of treatment
Change in baseline coronary flow reserve to assess the effect of lixisenatide on microvascular dysfunction
Measured: 2 days after the basal test and after 10 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Sponsor decision not related to safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 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
- NCT02274740
- Sponsor's protocol ID
- LIXISL07016
- Other IDs
- U1111-1153-3774
- Status last verified
- Jan 2017
- First submitted
- 17 Oct 2014
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GLP-1 Receptors Agonist Lixisenatide on Postprandial Lipid Profile in Obese Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02274740
- Acronym / sponsor ID
- LIXISL07016
- Conditions
- Type II Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision not related to safety reasons
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Oct 2014 (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 evaluate the ability of lixisenatide to modulate postprandial hyperlipidemia in particular, the effects on plasma changes in triglycerides.
Secondary Objectives:
The effect of lixisenatide on the following postprandial lipids: apolipoprotein (APO) B48; free fatty acid, lipoprotein distribution, cholesterol, and low-density lipoprotein (LDL) oxidation.
The effect of lixisenatide on chronic low-grade inflammation present in non-insulin dependent diabetes mellitus (NIDDM) and obesity.
The effect of lixisenatide on microvascular dysfunction. To evaluate the effect of lixisenatide on postprandial plasma glucose, insulin and C-peptide and glucagon.
Detailed description
Maximum study duration of approximately 2.5 months (study treatment) ± 2 days Day 0 (baseline) plus a 10-week open-label, active-controlled treatment period (Final/End-of-treatment Visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lixisenatide | Experimental | Drug: LIXISENATIDE AVE0010, Drug: metforminLixisenatide injection should be performed in the morning, within 1 hour (ie, 0-60 minutes), prior to breakfast (or standardized meal). Lixisenatide is to be started with once daily injections of 10 μg per day for 2 weeks then to be continued by the maintenance dose (8 weeks) of 20 μg/d up to the end of the treatment period. |
| metformin | No intervention | –Greater than or equal than 1.5 g/day as background therapy for 10 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients, 18-70 years of age.
- Diagnosis of Type 2 diabetes treated with metformin and obesity (body mass index [BMI] >30 kg/m^2) and the following other abnormalities:
- Abdominal obesity (waist circumference >102 cm in men and >88 cm in women). According to National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP) III (2001).
- Glycated hemoglobin A1c (HbA1c) ≥7 and ≤8.5% (after Sponsor approval providers might reasonably suggest more stringent A1c goals [such as 6.5%] for selected individual patients, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate patients might include those with short duration of diabetes, long life expectancy, and no significant cardiovascular disease).
- Hypertriglyceridemia (fasting triglyceride levels between 150 mg/dL and 600 mg/dL, cholesterol <300 mg/dL. In order to exclude patients who might be suffering from a primitive dyslipidemia).
Key exclusion criteria (5 listed)
- Smoking. Thyroid disease even if under appropriate hormonal replacement therapy or thyroid suppressant (Thyroid Stimulating Hormone [TSH] >5 mU/L with clinical symptoms of hypothyroidism).
- Hepatic disease (Aspartate Aminotransferase [ASAT] or Alanine Aminotransferase [ALAT] >2 times the upper limit of normal).
- Renal disease (serum creatinine >1.7 times the upper limit of normal). A history of coronary heart disease, cerebrovascular disease, or peripheral arterial disease in the 6 months before enrollment.
- History of malignancies. Use of lipid lowering therapy. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg. Triglycerides >600 mg/dL. History of chronic pancreatitis or of idiopathic acute pancreatitis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 | Drug | lixisenatide |
| metforminPharmaceutical form:tablet Route of administration: oral | Drug | lixisenatide |
Primary outcome
Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min)
Time frame: After 10 weeks of treatment
11 secondary outcomes
Change from baseline in plasma triglyceride
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in plasma cholesterol
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in APO B48
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in free fatty acid levels
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in lipoprotein distribution
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in LDL oxidation
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in postprandial plasma glucose
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in insulin
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in C-peptide
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change from baseline in low grade inflammation (cytokines and stress oxidative markers)
Time frame: 2 days after the basal test and after 10 weeks of treatment
Change in baseline coronary flow reserve to assess the effect of lixisenatide on microvascular dysfunction
Time frame: 2 days after the basal test and after 10 weeks of treatment
Results and safety
The study was stopped early (reason given: Sponsor decision not related to safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIXISENATIDE AVE0010 and metformin in people with Type II Diabetes Mellitus, run by Sanofi.
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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Sponsor decision not related to safety reasons). Results are not available in the source record.
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?
Change in plasma triglycerides after 10 weeks of treatment area under-the-time concentration curve between 0 and 480 minutes (AUC0-480 min) (time frame: After 10 weeks of treatment). 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 30 Jan 2017.