Type 1 DiabetesPhase 1NCT03903016
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
A Phase 1 study testing Insulin Lispro SAR342434 in people with Type 1 Diabetes, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose Secondary Objectives: To assess the pharmacodynamic profiles and further pharmacokinetic… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin Lispro SAR342434
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 26 Mar 2019to 19 Aug 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
- Total insulin dose of <1.0 U/kg/day
- Fasting serum C-peptide <0.30 nmol/L at screening
- Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening
- Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study).
- Patients with anti-insulin antibody titer at screening ≤ 30.0 kU/L
- Body weight between 50.0 kg and 100.0 kg, inclusive, il male , and between 40.0 and 90.0 kg, inclusive, if female, Body Mass Index between 18 and 30.0 kg/m², inclusive
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II)
- More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, 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
- If female, pregnancy (defined as positive β-HCG blood test), breast-feeding
- 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, Single-dose, 2-treatment, 2-period, 2-sequence Crossover Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
Primary Objective:
To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose
Secondary Objectives:
- To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose
- To assess the safety and tolerability of the test and the reference formulation of insulin lispro
Read the detailed description
Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin Lispro SAR342434
- 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 Lispro SAR342434Drug
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Insulin Lispro SAR342434Drug
Also called Insulin lispro Sanofi®
Pharmaceutical form:solution for injection Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Test (T) | Experimental | Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period Receives: Drug: Insulin Lispro SAR342434 |
| Reference (R) | Active comparator | Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period Receives: Drug: Insulin Lispro SAR342434 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacokinetc (PK) parameter:INS-Cmax
Maximum Insulin (INS) concentration
Measured: 10 hours
Assessment of PK parameter :INS-AUClast -
Area under INS concentration time curve from 0 to last measurable concentration -
Measured: 10 hours
Secondary outcomes (8)
Assessment of PK parameter:INS-AUC
Area under INS concentration time curve from 0 to infinity
Measured: 10 hours
Assessment of PK parameter:INS-tmax
Time to reach INS-Cmax
Measured: 10 hours
Assessment of PK parameter:INS-t1/2z
INS terminal half life
Measured: 10 hours
Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8
Area under the Glucose Infusion Rate (GIR) time curve from 0 to 8 hours
Measured: 8 hours
Assessment of PD parameter:GIR-max
Maximum smoothed GIR
Measured: 8 hours
Assessment of PD parameter:GIR-tmax
Time to reach GIR-max
Measured: 8 hours
Duration of blood glucose control
Duration of blood glucose control at or below 105 mg/dL
Measured: 8 hours
Adverse Events
Number of participants with adverse events
Measured: Up to Day 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start26 Mar 2019
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 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
- NCT03903016
- Sponsor's protocol ID
- BEQ15846
- Other IDs
- 2018-003131-30, U1111-1207-8959, 2018
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2019
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, 2-treatment, 2-period, 2-sequence Crossover Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03903016
- Acronym / sponsor ID
- BEQ15846
- Conditions
- Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 4 Apr 2019 (actual)
- 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 demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single subcutaneous (SC) dose
Secondary Objectives:
- To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of the test formulation (T) in comparison to the reference formulation (R) after a single SC dose
- To assess the safety and tolerability of the test and the reference formulation of insulin lispro
Detailed description
Study duration per participant is approximately 62 days including a screening period up to 28 days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7 days) and an end of study visit 7 to 14 days after the last dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (T) | Experimental | Drug: Insulin Lispro SAR342434Insulin Lispro (SAR342434), 200 Units/ml, single dose on day 1 of each period |
| Reference (R) | Active comparator | Drug: Insulin Lispro SAR342434Insulin Lispro Sanofi® ,100 Units/ml, single dose on day 1 of each period |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female patients, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year
- Total insulin dose of <1.0 U/kg/day
- Fasting serum C-peptide <0.30 nmol/L at screening
- Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%) at screening
- Stable insulin regimen for at least 2 months prior to study (day of insulin regimen switch, with respect to safety of the patient and scientific integrity of the study).
Key exclusion criteria (8 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness or any history or presence of HIT-type II (heparin induced thrombocytopenia Type II)
- More than 1 episode of severe hypoglycemia resulting in coma/seizures or requiring assistance of another person, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only, 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 |
|---|---|---|
| Insulin Lispro SAR342434Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | Test (T) |
| Insulin Lispro SAR342434Also: Insulin lispro Sanofi®Pharmaceutical form:solution for injection Route of administration: subcutaneous | Drug | Reference (R) |
Primary outcome
Assessment of pharmacokinetc (PK) parameter:INS-Cmax
Time frame: 10 hours
Maximum Insulin (INS) concentration
Assessment of PK parameter :INS-AUClast -
Time frame: 10 hours
Area under INS concentration time curve from 0 to last measurable concentration -
8 secondary outcomes
Assessment of PK parameter:INS-AUC
Time frame: 10 hours
Assessment of PK parameter:INS-tmax
Time frame: 10 hours
Assessment of PK parameter:INS-t1/2z
Time frame: 10 hours
Assessment of pharmacodynamic (PD) parameter:GIR-AUC0-8
Time frame: 8 hours
Assessment of PD parameter:GIR-max
Time frame: 8 hours
Assessment of PD parameter:GIR-tmax
Time frame: 8 hours
Duration of blood glucose control
Time frame: 8 hours
Adverse Events
Time frame: Up to Day 62
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 24 Sep 2025.
- BEQ15846 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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 Lispro SAR342434 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 7 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 24 Sep 2025. 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?
Assessment of pharmacokinetc (PK) parameter:INS-Cmax (time frame: 10 hours). 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 24 Sep 2025.