Type 1 Diabetes MellitusPhase 1NCT01146678
Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1
A Phase 1 study testing Insulin glargine HOE901 and Lixisenatide AVE0010 in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: to compare the activity of a single dose of insulin glargine and lixisenatide given… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin glargine HOE901 and Lixisenatide AVE0010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Jan 2011
- 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
- Subjects with type 1 diabetes mellitus for more than one year with total insulin dose of <1.2 U.kg/day, but otherwise healthy with glycohemoglobin (HbA1c) ≤ 9.0%, stable insulin regimen for at least 2 months prior to study, normal finding in medical history and physical examination.
Who cannot join
- any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type I), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness
- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
- Frequent severe headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month)
- Symptomatic hypotension, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
- Presence or history of a drug allergy to clinically significant allergic disease
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
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- Pregnant or breast feeding women
- Any medication within 14 days before inclusion, or within 5 times the elimination half-life of that drug, whichever the longest and regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy, any vaccination within the last 28 days.
- Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab)
- History of unexplained pancreatitis, chronic pancreatitis and/or pancreatectomy
- 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
1 site in 1 country.
About this study
Official title: A Randomized, Cross-over, Open, Euglycemic Clamp Study on the Relative Bioavailability and Activity of 0.6 U/kg Insulin Glargine and 20 μg Lixisenatide, Given as On-site Mix Compared to Separate Simultaneous Injections in Subjects With Type 1 Diabetes Mellitus
Primary Objective:
- to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
Secondary Objectives:
- to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
- to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
Read the detailed description
The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin glargine HOE901, Lixisenatide AVE0010
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargine HOE901Drug
Pharmaceutical form:solution for injection
Route of administration: subcutaneous
Lixisenatide AVE0010Drug
Pharmaceutical form:solution for injection
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Lantus(insulin glargine)/lixisenatide on-site mix | Experimental | Single dose injection of an on site mix of Lantus U100 and lixisenatide (800µg/mL in Lantus U100) at one peri-umbilical site under fasting conditions Receives: Drug: Insulin glargine HOE901; Drug: Lixisenatide AVE0010 |
| lixisenatide + Lantus (insulin glargine) | Active comparator | Single dose, separate injection simultaneous injections of Lantus U100 and lixisenatide (100µg/mL) at opposite peri-umbilical sites within 1 minute under fasting conditions Receives: Drug: Insulin glargine HOE901; Drug: Lixisenatide AVE0010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma lixisenatide concentration curve (LIX-AUClast)
Measured: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax)
Measured: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Secondary outcomes (6)
Area under the plasma lixisenatide concentration curve (AUC)
Measured: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to Cmax (Tmax ) for lixisenatide
Measured: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24)
Measured: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to 50% of the GIR-AUC within 24 h (T50%-GIR AUC0-24)
Measured: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Maximum smoothed body weight standardized glucose infusion rate GIRmax
Measured: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to GIRmax (GIR-Tmax)
Measured: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 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
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146678
- Sponsor's protocol ID
- BDR11578
- Other IDs
- 2010-019228-30, U1111-1116-8960
- Status last verified
- Mar 2011
- First submitted
- 16 Jun 2010
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Cross-over, Open, Euglycemic Clamp Study on the Relative Bioavailability and Activity of 0.6 U/kg Insulin Glargine and 20 μg Lixisenatide, Given as On-site Mix Compared to Separate Simultaneous Injections in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01146678
- Acronym / sponsor ID
- BDR11578
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Jun 2010 (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 relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
Secondary Objectives:
- to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug
- to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
Detailed description
The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lantus(insulin glargine)/lixisenatide on-site mix | Experimental | Drug: Insulin glargine HOE901, Drug: Lixisenatide AVE0010Single dose injection of an on site mix of Lantus U100 and lixisenatide (800µg/mL in Lantus U100) at one peri-umbilical site under fasting conditions |
| lixisenatide + Lantus (insulin glargine) | Active comparator | Drug: Insulin glargine HOE901, Drug: Lixisenatide AVE0010Single dose, separate injection simultaneous injections of Lantus U100 and lixisenatide (100µg/mL) at opposite peri-umbilical sites within 1 minute under fasting conditions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with type 1 diabetes mellitus for more than one year with total insulin dose of <1.2 U.kg/day, but otherwise healthy with glycohemoglobin (HbA1c) ≤ 9.0%, stable insulin regimen for at least 2 months prior to study, normal finding in medical history and physical examination.
Key exclusion criteria (11 listed)
- any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type I), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness
- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
- Frequent severe headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month)
- Symptomatic hypotension, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position
- Presence or history of a drug allergy to clinically significant allergic disease
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 |
|---|---|---|
| Insulin glargine HOE901Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | Lantus(insulin glargine)/lixisenatide on-site mix, lixisenatide + Lantus (insulin glargine) |
| Lixisenatide AVE0010Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | Lantus(insulin glargine)/lixisenatide on-site mix, lixisenatide + Lantus (insulin glargine) |
Primary outcome
Area under the plasma lixisenatide concentration curve (LIX-AUClast)
Time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax)
Time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
6 secondary outcomes
Area under the plasma lixisenatide concentration curve (AUC)
Time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to Cmax (Tmax ) for lixisenatide
Time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24)
Time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to 50% of the GIR-AUC within 24 h (T50%-GIR AUC0-24)
Time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Maximum smoothed body weight standardized glucose infusion rate GIRmax
Time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
Time to GIRmax (GIR-Tmax)
Time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period
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 2 Mar 2011.
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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
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 Insulin glargine HOE901 and Lixisenatide AVE0010 in people with Type 1 Diabetes Mellitus, 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 1 inclusion and 11 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 2 Mar 2011. 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 plasma lixisenatide concentration curve (LIX-AUClast) (time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period). The study lists 2 primary outcomes in all. 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 2 Mar 2011.