Type 2 Diabetes MellitusPhase 1NCT01572649
Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes
A Phase 1 study testing Lixisenatide (AVE0010) in people with Type 2 Diabetes Mellitus, run by Sanofi at 6 sites in 4 countries.
Trial summary
Primary Objective: To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls Secondary Objectives: To evaluate in both paediatric and adult… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 6 sitesin 4 countries
- Study dates
- May 2012to Mar 2014
- 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 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year (adults) and at least 3 months for paediatric population at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization)
- HbA1c ≥ 7% and ≤ 10% at screening
- Age eligibility for paediatric population: ≥ 10 years and <18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: ≥ 18 and ≤ 65 years
- For paediatric population:body weight >50kg, BMI >85th percentile for age and gender and BMI ≤ 50 kg/m²
- For adults: BMI > 25 kg/m2 and ≤ 37 kg/m2
Who cannot join
- If female, pregnancy (defined as positive serum pregnancy test), breast-feeding
- Diabetes other than type 2 diabetes
- Positive test for insulinoma associated protein (IA2) and glutamic acid decarboxylase (GAD) autoantibodies
- Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening
- Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) or to metacresol
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
- Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes)
- 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
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Investigational Site Number 840005
Chula Vista, California, 91911
Investigational Site Number 840003
Louisville, Kentucky, 40202
Investigational Site Number 840001
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Paediatric (10 - 17 Years Old) and Adult Patients With Type 2 Diabetes
Primary Objective:
- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls
Secondary Objectives:
- To evaluate in both paediatric and adult populations:
- the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses
- the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast
- safety and tolerability.
Read the detailed description
The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose administration.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Lixisenatide (AVE0010), Placebo
- 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
Pharmaceutical form:Solution for injection
Route of administration: subcutaneous
PlaceboDrug
Pharmaceutical form:Solution for injection
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously Receives: Drug: Placebo |
| Dose 1 | Experimental | 1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously Receives: Drug: Lixisenatide (AVE0010) |
| Dose 2 | Experimental | 1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously Receives: Drug: Lixisenatide (AVE0010) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value
Measured: D1 at each period up to 4h30 after study drug injection (8 timepoints)
Secondary outcomes (6)
Pharmacokinetics: lixisenatide plasma concentration
Measured: 0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints)
Pharmacokinetic parameter (Cmax)
Measured: calculated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (Tmax)
Measured: calculated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (AUC last)
Measured: estimated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (AUC)
Measured: extrapolated based on the period of timepoints at D1 of each study period
Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon
Measured: D1 at each period up to 4h30 after study drug injection (7 timepoints)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 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
- NCT01572649
- Sponsor's protocol ID
- PKD11475
- Other IDs
- 2011-004584-67, U1111-1124-3136
- Status last verified
- May 2014
- First submitted
- 4 Apr 2012
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Paediatric (10 - 17 Years Old) and Adult Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01572649
- Acronym / sponsor ID
- PKD11475
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Apr 2012 (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 investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls
Secondary Objectives:
- To evaluate in both paediatric and adult populations:
- the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses
- the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast
- safety and tolerability.
Detailed description
The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo1 single administration (volume matched to the dose lixisenatide: 50 µL or 100µL) once a day subcutaneously |
| Dose 1 | Experimental | Drug: Lixisenatide (AVE0010)1 single administration of 5 µg lixisenatide (50 µL) once a day subcutaneously |
| Dose 2 | Experimental | Drug: Lixisenatide (AVE0010)1 single administration of 10 µg lixisenatide (100 µL) once a day subcutaneously |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year (adults) and at least 3 months for paediatric population at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization)
- HbA1c ≥ 7% and ≤ 10% at screening
- Age eligibility for paediatric population: ≥ 10 years and <18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: ≥ 18 and ≤ 65 years
- For paediatric population:body weight >50kg, BMI >85th percentile for age and gender and BMI ≤ 50 kg/m²
- For adults: BMI > 25 kg/m2 and ≤ 37 kg/m2
Key exclusion criteria (8 listed)
- If female, pregnancy (defined as positive serum pregnancy test), breast-feeding
- Diabetes other than type 2 diabetes
- Positive test for insulinoma associated protein (IA2) and glutamic acid decarboxylase (GAD) autoantibodies
- Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening
- Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) or to metacresol
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)Pharmaceutical form:Solution for injection Route of administration: subcutaneous | Drug | Dose 1, Dose 2 |
| PlaceboPharmaceutical form:Solution for injection Route of administration: subcutaneous | Drug | Placebo |
Primary outcome
GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value
Time frame: D1 at each period up to 4h30 after study drug injection (8 timepoints)
6 secondary outcomes
Pharmacokinetics: lixisenatide plasma concentration
Time frame: 0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints)
Pharmacokinetic parameter (Cmax)
Time frame: calculated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (Tmax)
Time frame: calculated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (AUC last)
Time frame: estimated over the period of timepoints at D1 of each study period
Pharmacokinetic parameter (AUC)
Time frame: extrapolated based on the period of timepoints at D1 of each study period
Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon
Time frame: D1 at each period up to 4h30 after study drug injection (7 timepoints)
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 May 2014.
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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
6 sites in 4 countries: 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 Type 2 Diabetes Mellitus, run by Sanofi at 6 sites in 4 countries.
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 5 inclusion and 8 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Mexico, South Africa, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value (time frame: D1 at each period up to 4h30 after study drug injection (8 timepoints)). 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 May 2014.