Type 1 Diabetes MellitusPhase 1NCT02625636
A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients
A Phase 1 study testing SAR438544 and r-glucagon in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in United States.
Trial summary
Primary Objective: To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- SAR438544 and r-glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Feb 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects:
- Male or female subjects, between 18 and 45 years of age, inclusive.
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Female subject must use a double contraception method, including a highly effective method of birth control, except if she has undergone sterilization defined as tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and bilateral tubal ligation at least 3 months earlier or is postmenopausal.
- The accepted double contraception methods include the use of intrauterine device or hormonal contraception started at least 30 days prior to the screening start and continued for at least 3 months after IMP dosing in addition to one of the following contraceptive options: (1) condom plus spermicide; (2) diaphragm plus spermicide or cervical/vault cap plus spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma FSH level >30 UI/L in women older than 40 years of age
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- Having given written informed consent prior to undertaking any study-related procedure.
- Not under any administrative or legal supervision.
- Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom, diaphragm or cervical cap, plus spermicide) plus (intra-uterine device or hormonal contraceptive) from the inclusion up to 3 months after the last dosing (except if sterilized).
- Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 3 months after the last dosing.
- Male subject has agreed not to donate sperm from the inclusion up to 3 months after the last dosing.
- T1DM patients:
- Male or female patients, between 18 and 60 years of age, inclusive, with T1DM for at least one year, as defined by the American Diabetes Association.
- Total (basal+short acting) daily insulin dose of <1.2 U/kg/day.
- Body weight between 50.0 and 110 kg, inclusive, the BMI between 18.5 and 30.0 kg/m^2, inclusive.
- Fasting serum C-peptide <0.3 nmol/L.
- Glycohemoglobin (HbA1c) ≤75 mmol/mol (≤9%).
- Stable insulin regimen for at least 2 months prior to study and self-monitoring of blood glucose before screening visit.
- Certified as otherwise healthy for T1DM by assessment of medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculoskeletal system), unless the Investigator considers any abnormality to be clinically irrelevant and not interfering with the conduct of the study.
- Female subject must use a double contraception method, including a highly effective method of birth control, except if she has undergone sterilization defined as tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and bilateral tubal ligation at least 3 months earlier or is postmenopausal.
- The accepted double contraception methods include the use of intrauterine device or hormonal contraception started at least 30 days prior to the screening start and continued for at least 3 months after IMP dosing in addition to one of the following contraceptive options: (1) condom plus spermicide; (2) diaphragm plus spermicide or cervical/vault cap plus spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma FSH level >30 UI/L in women older than 40 years of age.
- Having given written informed consent prior to undertaking any study-related procedure.
- Not under any administrative or legal supervision.
- Male subject, whose partners are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method according to the following algorithm: (condom, diaphragm or cervical cap, plus spermicide) plus (intra-uterine device or hormonal contraceptive) from the inclusion up to 3 months after the last dosing (except if sterilized).
- Male subject, whose partners are pregnant, must use, during sexual intercourse, a condom from the inclusion up to 3 months after the last dosing.
- Male subject has agreed not to donate sperm from the inclusion up to 3 months after the last dosing.
Who cannot join
- Healthy subjects:
- 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.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- 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 any drug allergy or allergic disease that in the opinion of the Investigator may interfere with subject safety or data integrity during the study.
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- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
- Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study.
- If female, pregnancy (defined as positive beta-human chorionic gonadotropin [β-HCG] blood test), breast-feeding.
- Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or PD half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- 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) and human immunodeficiency virus 1 antigen (HIV1 Ag).
- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol breath test.
- T1DM patients:
- Any history or presence of clinically relevant cardiovascular (includes ischemia, atrioventricular [AV] block; arrhythmias), pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
- 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 severe headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Blood loss (>300 mL) within 3 months before inclusion.
- 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 any drug allergy or allergic disease that in the opinion of the Investigator may interfere with patient safety or data integrity during the study.
- 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 at screening and before any treatment periods (defined as positive β-HCG urine test).
- Any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- Positive result on any of the following tests: HBs Ag, anti-HCV Abs, anti-HIV1 and anti-HIV2 Abs and HIV1 Ag.
- Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol breath test.
- Known hypersensitivity to glucagon, lactose or any other constituent in GlucaGen^® HypoKit and SAR438544 and their excipients.
- Any contraindication from the use of glucagon:
- Pheochromocytoma
- Insulinoma and glucagonoma
- 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.
United States1 site
Investigational Site Number 840001
Chula Vista, California, 91911
About this study
Official title: A Randomized, Double-blind, Glucagon and Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Single Escalating Doses of SAR438544 Administered by Subcutaneous Route in Healthy Subjects and Patients With Type 1diabetes Mellitus
Primary Objective:
To assess the tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.
Secondary Objective:
To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.
Read the detailed description
Healthy subjects:
The total duration of study per subject is up to 4.5 weeks with 2 to 21 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.
T1DM patients:
The total duration of study per patient is up to 5.5 weeks with 3 to 28 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.
One or more interim analyses may be performed to support decisions for the next steps of the study.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- SAR438544, placebo, r-glucagon
- 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.
SAR438544Drug
Pharmaceutical form: solution
Route of administration: subcutaneous
placeboDrug
Pharmaceutical form: solution
Route of administration: subcutaneous
r-glucagonDrug
Also called GlucaGen® HypoKit, glucagon
Pharmaceutical form: solution
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| SAR438544 dose 1 | Experimental | Single dose of SAR438544 given SC under fasting conditions Receives: Drug: SAR438544 |
| SAR438544 dose 2 | Experimental | Single dose of SAR438544 given SC under fasting conditions Receives: Drug: SAR438544 |
| SAR438544 dose 3 | Experimental | Single dose of SAR438544 given SC under fasting conditions Receives: Drug: SAR438544 |
| Placebo | Placebo comparator | Single dose of placebo given SC under fasting conditions Receives: Drug: placebo |
| Glucagon | Active comparator | Single dose of glucagon given SC under fasting conditions Receives: Drug: r-glucagon |
| SAR438544 Optional Dose | Experimental | Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions Receives: Drug: SAR438544 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Measured: Day 1 to Day 7 (+/- 1 day)
Secondary outcomes (11)
Assessment of PD parameter: continuous monitoring of blood glucose levels over a period of 6 hours post-dose
Measured: Day 1
Assessment of PD parameter: area under plasma concentration of the BG-time curve between investigational medicinal product (IMP) dosing and time t (BG-AUC0-t)
Measured: Day 1
Assessment of PD parameter: BG-maximum concentration (BG-Cmax)
Measured: Day 1
Assessment of PD parameter: BG-time to Cmax (BG-tmax)
Measured: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): Cmax
Measured: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): tmax
Measured: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): tlast
Measured: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half life
Measured: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): area under curve from zero time until the last measurable concentration (AUClast)
Measured: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): AUC
Measured: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): partial AUCs (AUC0-t)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT02625636
- Sponsor's protocol ID
- TDU14518
- Other IDs
- U1111-1172-1152
- Status last verified
- Aug 2016
- First submitted
- 7 Dec 2015
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Glucagon and Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Single Escalating Doses of SAR438544 Administered by Subcutaneous Route in Healthy Subjects and Patients With Type 1diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02625636
- Acronym / sponsor ID
- TDU14518
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Dec 2015 (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 tolerability and safety of SAR438544 after single ascending subcutaneous (SC) doses in healthy subjects and in type 1 diabetes mellitus (T1DM) patients.
Secondary Objective:
To assess the preliminary pharmacodynamics (PD) and pharmacokinetic (PK) parameters of SAR438544 after single ascending SC doses in healthy subjects and in T1DM patients.
Detailed description
Healthy subjects:
The total duration of study per subject is up to 4.5 weeks with 2 to 21 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.
T1DM patients:
The total duration of study per patient is up to 5.5 weeks with 3 to 28 days screening period, 1 day for treatment, and 7 days (+/- 1 day) follow-up after IMP administration.
One or more interim analyses may be performed to support decisions for the next steps of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SAR438544 dose 1 | Experimental | Drug: SAR438544Single dose of SAR438544 given SC under fasting conditions |
| SAR438544 dose 2 | Experimental | Drug: SAR438544Single dose of SAR438544 given SC under fasting conditions |
| SAR438544 dose 3 | Experimental | Drug: SAR438544Single dose of SAR438544 given SC under fasting conditions |
| Placebo | Placebo comparator | Drug: placeboSingle dose of placebo given SC under fasting conditions |
| Glucagon | Active comparator | Drug: r-glucagonSingle dose of glucagon given SC under fasting conditions |
| SAR438544 Optional Dose | Experimental | Drug: SAR438544Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Male or female subjects, between 18 and 45 years of age, inclusive.
- Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m^2, inclusive.
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Female subject must use a double contraception method, including a highly effective method of birth control, except if she has undergone sterilization defined as tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and bilateral tubal ligation at least 3 months earlier or is postmenopausal.
- The accepted double contraception methods include the use of intrauterine device or hormonal contraception started at least 30 days prior to the screening start and continued for at least 3 months after IMP dosing in addition to one of the following contraceptive options: (1) condom plus spermicide; (2) diaphragm plus spermicide or cervical/vault cap plus spermicide. Menopause is defined as being amenorrheic for at least 2 years with plasma FSH level >30 UI/L in women older than 40 years of age
Key exclusion criteria (32 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.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- Blood donation, any volume, within 2 months before inclusion.
- 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 any drug allergy or allergic disease that in the opinion of the Investigator may interfere with subject safety or data integrity during the study.
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 |
|---|---|---|
| SAR438544Pharmaceutical form: solution Route of administration: subcutaneous | Drug | SAR438544 Optional Dose, SAR438544 dose 1, SAR438544 dose 2, SAR438544 dose 3 |
| placeboPharmaceutical form: solution Route of administration: subcutaneous | Drug | Placebo |
| r-glucagonAlso: GlucaGen® HypoKit, glucagonPharmaceutical form: solution Route of administration: subcutaneous | Drug | Glucagon |
Primary outcome
Number of patients with adverse events
Time frame: Day 1 to Day 7 (+/- 1 day)
11 secondary outcomes
Assessment of PD parameter: continuous monitoring of blood glucose levels over a period of 6 hours post-dose
Time frame: Day 1
Assessment of PD parameter: area under plasma concentration of the BG-time curve between investigational medicinal product (IMP) dosing and time t (BG-AUC0-t)
Time frame: Day 1
Assessment of PD parameter: BG-maximum concentration (BG-Cmax)
Time frame: Day 1
Assessment of PD parameter: BG-time to Cmax (BG-tmax)
Time frame: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): Cmax
Time frame: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): tmax
Time frame: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): tlast
Time frame: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half life
Time frame: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): area under curve from zero time until the last measurable concentration (AUClast)
Time frame: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): AUC
Time frame: Day 1
Assessment of PK parameter (recombinant glucagon and SAR438544): partial AUCs (AUC0-t)
Time frame: Day 1
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 Aug 2016.
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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 SAR438544 and r-glucagon in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in United States.
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 26 inclusion and 32 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 Aug 2016. 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 United States. 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?
Number of patients with adverse events (time frame: Day 1 to Day 7 (+/- 1 day)). 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 Aug 2016.