Type 1 DiabetesPhase 1NCT02273258
A Study to Compare Pharmacokinetics and Pharmacodynamics of SAR342434 to Insulin Lispro in Subjects With Type 1 Diabetes
A Phase 1 study testing SAR342434 and Insulin Lispro in people with Type 1 Diabetes, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®. Secondary Objective: To assess the safety and tolerability of SAR342434. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- SAR342434 and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Jul 2013
- 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 or female subjects with diabetes mellitus type 1 for more than one year.
- Total insulin dose of < 1.2 U/kg/day.
- Fasting negative serum C-peptide (< 0.3 nmol/L).
- Glycohemoglobin (HbA1c) ≤ 9%.
- Stable insulin regimen for at least 2 months prior to study.
- Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab.
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or 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 headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
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- Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of insulins, 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 result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab.
- Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in 1st degree relatives (parents, siblings or children).
- 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, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus
Primary Objective:
To compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.
Secondary Objective:
To assess the safety and tolerability of SAR342434.
Read the detailed description
The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)
- Screening: 2 to 28 days (D -28 to D -2)
- Treatment period 1 - 3: 2 days (1 overnight stay)
- Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)
- End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.
- Conditions
- Type 1 Diabetes
- Being tested
- SAR342434, Insulin Lispro
- 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.
SAR342434Drug
Pharmaceutical form:solution Route of administration: subcutaneous
Insulin LisproDrug
Pharmaceutical form:solution Route of administration: subcutaneous
Insulin LisproDrug
Pharmaceutical form:solution Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Test (T) | Experimental | SAR342434: single dose injection Receives: Drug: SAR342434 |
| Reference 1 (R1) | Active comparator | US-approved Humalog®: single dose injection Receives: Drug: Insulin Lispro |
| Reference 2 (R2) | Active comparator | EU-approved Humalog®: single dose injection Receives: Drug: Insulin Lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog
Measured: 12 hours
Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog
Measured: 12 hours
Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)
Measured: 12 hours
Secondary outcomes (9)
The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)
Measured: 12 hours
Time to 20% of AUC (t20%-AUC)
Measured: 12 hours
NS-tmax, INS-t1/2z
Measured: 12 hours
The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X)
Measured: 12 hours
Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)
Measured: 12 hours
Maximum smoothed body weight standardized GIR (GIRmax)
Measured: 12 hours
Time to GIRmax (GIR-tmax)
Measured: 12 hours
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)
Measured: 12 hours
Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- 30 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
- NCT02273258
- Sponsor's protocol ID
- PDY12704
- Other IDs
- 2012-004453-86, U1111-1134-4816
- Status last verified
- Oct 2014
- First submitted
- 21 Oct 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled, Single-Dose, 3-Treatment, 3-Period, 6-Sequence Crossover Study to Compare Exposure and Activity of SAR342434 to Humalog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02273258
- Acronym / sponsor ID
- PDY12704
- Conditions
- Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 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 compare exposure and activity of SAR342434 to US-approved and EU-approved Humalog®.
Secondary Objective:
To assess the safety and tolerability of SAR342434.
Detailed description
The total study duration for a screened subject will be about 3 - 8 weeks (min-max duration, excl. screening)
- Screening: 2 to 28 days (D -28 to D -2)
- Treatment period 1 - 3: 2 days (1 overnight stay)
- Washout: 5 - 18 days (preferentially 7 days between consecutive dosing)
- End-of-study visit: 1 day between D 5 and D14 after last administration of investigational product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test (T) | Experimental | Drug: SAR342434SAR342434: single dose injection |
| Reference 1 (R1) | Active comparator | Drug: Insulin LisproUS-approved Humalog®: single dose injection |
| Reference 2 (R2) | Active comparator | Drug: Insulin LisproEU-approved Humalog®: single dose injection |
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 or female subjects with diabetes mellitus type 1 for more than one year.
- Total insulin dose of < 1.2 U/kg/day.
- Fasting negative serum C-peptide (< 0.3 nmol/L).
- Glycohemoglobin (HbA1c) ≤ 9%.
- Stable insulin regimen for at least 2 months prior to study.
Key exclusion criteria (10 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or 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 headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month.
- Symptomatic postural hypotension, irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 3 minutes when changing from supine to standing position.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
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 |
|---|---|---|
| SAR342434Pharmaceutical form:solution Route of administration: subcutaneous | Drug | Test (T) |
| Insulin LisproPharmaceutical form:solution Route of administration: subcutaneous | Drug | Reference 1 (R1) |
| Insulin LisproPharmaceutical form:solution Route of administration: subcutaneous | Drug | Reference 2 (R2) |
Primary outcome
Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog
Time frame: 12 hours
Area under the concentration versus time curve (AUC) of SAR342434, US-approved Humalog and EU-approved Humalog
Time frame: 12 hours
Area under the body weight standardized glucose infusion rate (GIR) versus time curve from 0 to 12 hours post administration (GIR-AUC0-12)
Time frame: 12 hours
9 secondary outcomes
The fractional area under the concentration versus time curve from 0 or y to x hours post administration (INS-AUC0 or Y to X)
Time frame: 12 hours
Time to 20% of AUC (t20%-AUC)
Time frame: 12 hours
NS-tmax, INS-t1/2z
Time frame: 12 hours
The fractional area under the body weight standardized GIR versus time curve from 0 or y to x hours post administration (GIR-AUC0 or Y to X)
Time frame: 12 hours
Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h)
Time frame: 12 hours
Maximum smoothed body weight standardized GIR (GIRmax)
Time frame: 12 hours
Time to GIRmax (GIR-tmax)
Time frame: 12 hours
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)
Time frame: 12 hours
Number of patients with AEs, SAEs, laboratory, vital signs and electrocardiographic abnormalities , injections site reaction assessment (ISR), and if any, hypoglycemia
Time frame: 8 weeks
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 Oct 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
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 SAR342434 and Insulin Lispro in people with Type 1 Diabetes, 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 10 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 Oct 2014. 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?
Maximum plasma concentration (Cmax) of SAR342434, US-approved Humalog and EU-approved Humalog (time frame: 12 hours). The study lists 3 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 23 Oct 2014.