Type 1 DiabetesPhase 1NCT03202875
A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
A Phase 1 study testing SAR341402 and Insulin Aspart in people with Type 1 Diabetes, run by Sanofi at 1 site in Germany.
Trial summary
Primary Objective: To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®. Secondary Objective: To assess the safety and tolerability of SAR341402. 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?
- SAR341402 and Insulin Aspart
- 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
- 14 Nov 2012to 28 Dec 2012
- 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.
Show all 9Show fewer
- 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.
- 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 SAR341402 to NovoRapid® and NovoLog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus
Primary Objective:
To compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.
Secondary Objective:
To assess the safety and tolerability of SAR341402.
Read the detailed description
The total study duration for a screened subject will be about 3 - 8 weeks (excluding screening of 2 to 28 days), treatment period of 2 days for each 3 periods (1 overnight stay), a washout period of 5-18 days (preferentially 7 days between consecutive dosing), and an end-of-study visit of 1 day between Days 5 and 14 after the last administration of the investigational product.
- Conditions
- Type 1 Diabetes
- Being tested
- SAR341402, Insulin Aspart
- 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.
SAR341402Drug
Pharmaceutical form: solution
Route of administration: subcutaneous
Insulin AspartDrug
Also called NovoRapid®
Pharmaceutical form: solution
Route of administration: subcutaneous
Insulin AspartDrug
Also called NovoLog®
Pharmaceutical form: solution
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Test (T) | Experimental | SAR341402: single dose injection Receives: Drug: SAR341402 |
| Reference 1 (R1) | Active comparator | NovoRapid®: single dose injection Receives: Drug: Insulin Aspart |
| Reference 2 (R2) | Active comparator | NovoLog®: single dose injection Receives: Drug: Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of PK parameters: maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax) of SAR341402, NovoRapid and NovoLog within 12 hours
Measured: 12 hours
Assessment of PK parameters: Area under the concentration versus time curve (AUC)
INS-AUC of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours
Measured: 12 hours
Assessment of PK parameter: AUC from dosing to last concentration (AUClast)
INS-AUClast is AUC from the time of dosing to the last measurable concentration of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours
Measured: 12 hours
Assessment of PD parameters: Area under the body weight standardized glucose infusion rate (GIR)
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)
Assessment of PK: Fractional area under the concentration versus time curve
INS-AUC0-2 and INS-AUC4-tlast
Measured: 12 hours
Assessment of PK: Time to 20 % of INS-AUC
Time to 20% of AUC (t20%-INS-AUC) within 12 hours
Measured: 12 hours
Assessment of PK: time to reach INS-Cmax (INS-tmax)
INS-tmax within 12 hours
Measured: 12 hours
Assessment of PK: time to reach INS-t1/2z (INS-t1/2z)
INS-t1/2z within 12 hours
Measured: 12 hours
Assessment of PD: Fractional area under the body weight standardized GIR versus time curve
GIR-AUC0-2 and GIR-AUC4-12
Measured: 12 hours
Assessment of PD: Time to 20 % of total GIR-AUC0-12h
Time to 20% of total GIR-AUC0-12h (t20%-GIR-AUC0-12h) within 12 hours
Measured: 12 hours
Assessment of PD: Maximum smoothed body weight standardized GIR (GIRmax)
Maximum smoothed body weight standardized GIR (GIRmax) within 12 hours
Measured: 12 hours
Assessment of PD: Time to GIRmax (GIR-tmax)
Time to GIRmax (GIR-tmax) within 12 hours
Measured: 12 hours
Number of adverse events (AEs)
Number of patients with treatment emergent AEs and serious adverse events (SAEs)
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 posted29 Jun 2017
- Study start14 Nov 2012
- Primary completion28 Dec 2012
- Study completion28 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT03202875
- Sponsor's protocol ID
- PDY12695
- Other IDs
- 2012-002355-42, U1111-1127-2950
- Status last verified
- Apr 2022
- First submitted
- 27 Jun 2017
- Last updated
- 25 Apr 2022
- 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
Publications
Kapitza C, Nosek L, Schmider W, Teichert L, Nowotny I. Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes. Diabetes Technol Ther. 2020 Apr;22(4):278-284. doi: 10.1089/dia.2019.0351. Epub 2019 Dec 30.
PubMed 31825248
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. 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 SAR341402 to NovoRapid® and NovoLog® Using the Euglycemic Clamp Technique, in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03202875
- Acronym / sponsor ID
- PDY12695
- 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
- 14 Nov 2012 (actual)
- Primary completion
- 28 Dec 2012 (actual)
- Study completion
- 28 Dec 2012 (actual)
- First posted
- 29 Jun 2017 (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 compare exposure and activity of SAR341402 to NovoRapid® and NovoLog®.
Secondary Objective:
To assess the safety and tolerability of SAR341402.
Detailed description
The total study duration for a screened subject will be about 3 - 8 weeks (excluding screening of 2 to 28 days), treatment period of 2 days for each 3 periods (1 overnight stay), a washout period of 5-18 days (preferentially 7 days between consecutive dosing), and an end-of-study visit of 1 day between Days 5 and 14 after the last administration of the 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: SAR341402SAR341402: single dose injection |
| Reference 1 (R1) | Active comparator | Drug: Insulin AspartNovoRapid®: single dose injection |
| Reference 2 (R2) | Active comparator | Drug: Insulin AspartNovoLog®: 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 (9 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 |
|---|---|---|
| SAR341402Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Test (T) |
| Insulin AspartAlso: NovoRapid®Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Reference 1 (R1) |
| Insulin AspartAlso: NovoLog®Pharmaceutical form: solution Route of administration: subcutaneous | Drug | Reference 2 (R2) |
Primary outcome
Assessment of PK parameters: maximum plasma concentration (Cmax)
Time frame: 12 hours
Maximum plasma concentration (Cmax) of SAR341402, NovoRapid and NovoLog within 12 hours
Assessment of PK parameters: Area under the concentration versus time curve (AUC)
Time frame: 12 hours
INS-AUC of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours
Assessment of PK parameter: AUC from dosing to last concentration (AUClast)
Time frame: 12 hours
INS-AUClast is AUC from the time of dosing to the last measurable concentration of SAR341402, NovoRapid, and NovoLog from 0 to 12 hours
Assessment of PD parameters: Area under the body weight standardized glucose infusion rate (GIR)
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)
9 secondary outcomes
Assessment of PK: Fractional area under the concentration versus time curve
Time frame: 12 hours
Assessment of PK: Time to 20 % of INS-AUC
Time frame: 12 hours
Assessment of PK: time to reach INS-Cmax (INS-tmax)
Time frame: 12 hours
Assessment of PK: time to reach INS-t1/2z (INS-t1/2z)
Time frame: 12 hours
Assessment of PD: Fractional area under the body weight standardized GIR versus time curve
Time frame: 12 hours
Assessment of PD: Time to 20 % of total GIR-AUC0-12h
Time frame: 12 hours
Assessment of PD: Maximum smoothed body weight standardized GIR (GIRmax)
Time frame: 12 hours
Assessment of PD: Time to GIRmax (GIR-tmax)
Time frame: 12 hours
Number of adverse events (AEs)
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 25 Apr 2022.
- Derived from this study: PubMed 31825248Kapitza C, Nosek L, Schmider W, Teichert L, Nowotny I. Single-Dose Euglycemic Clamp Study Demonstrating Pharmacokinetic and Pharmacodynamic Similarity Between SAR341402 Insulin Aspart and US- and EU-Approved Versions of Insulin Aspart in Subjects with Type 1 Diabetes. Diabetes Technol Ther. 2020 Apr;22(4):278-284. doi: 10.1089/dia.2019.0351. Epub 2019 Dec 30.
- 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
Related trials for Type 1 Diabetes
Recruiting
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
Type 1 Diabetes
RecruitingPhase 3
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
CKM For Safe Use of SGLT2i in Type 1 Diabetes
Type 1 Diabetes (T1D)
Active, not recruitingPhase 1
Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen
Diabetes Mellitus
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1
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 SAR341402 and Insulin Aspart 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 9 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 25 Apr 2022. 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 PK parameters: maximum plasma concentration (Cmax) (time frame: 12 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03202875, which also lists 1 linked publication.
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 25 Apr 2022.