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Type 1 Diabetes MellitusPhase 1NCT02635243

A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia

A Phase 1 study testing SAR438544, r-glucagon and insulin in people with Type 1 Diabetes Mellitus, run by Sanofi.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Primary Objective: To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544 versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced hypoglycemia. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
SAR438544, r-glucagon and insulin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2016to Nov 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
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 (ADA).
  • Total (basal+short acting) daily insulin dose of <1.2 U/kg/day.
  • Body weight between 50.0 and 110 kg, inclusive, the body mass index (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.
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  • 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 follicle-stimulating hormone (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

  • Any history or presence of clinically relevant cardiovascular (includes ischemia, atrioventricular (AV) block; arrhythmias), pulmonary, gastrointestinal, hepatic, renal, metabolic (apart from T1DM), 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 (BP), or asymptomatic postural hypotension defined as a decrease in systolic BP ≥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.
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  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.
  • If female, pregnancy (defined as positive beta-human chorionic gonadotropin [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: hepatitis B surface antigen (HBs Ag), anti-hepatitis C virus (HCV) Abs, anti-human immunodeficiency virus 1 (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 or Novolin^®R 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.

About this study

Official title: SAR438544 - Clinical & Exploratory Pharmacology

Primary Objective:

To assess the pharmacodynamic response (PD) of a single subcutaneous (SC) dose of SAR438544 versus recombinant glucagon in type 1 diabetes mellitus (T1DM) patients under induced hypoglycemia.

Secondary Objective:

To assess the safety and tolerability and pharmacokinetics (PK) of a single SC dose of SAR438544 versus recombinant glucagon in T1DM patients under induced hypoglycemia.

Read the detailed description

The total duration of study per patient is up to 8 weeks with 3 to 28 days screening period, 1 day for treatment for both periods and 7 to 14 days wash out between 2 administrations, and 7 days (+/- 1 day) follow-up after last IMP administration.

Being tested
SAR438544, r-glucagon, insulin
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

  • r-glucagonDrug

    Also called GlucaGen® HypoKit

    Pharmaceutical form:solution

    Route of administration: subcutaneous

  • insulinDrug

    Also called Novolin® R

    Pharmaceutical form:solution

    Route of administration: intravenous

Study groups in NCT02635243
Study groupRoleWhat they receive
SAR438544 dose 1ExperimentalSingle dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
Receives: Drug: SAR438544; Drug: insulin
GlucagonActive comparatorSingle dose of glucagon given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
Receives: Drug: r-glucagon; Drug: insulin
SAR438544 Optional DoseExperimentalOptional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions and under induced hypoglycemia. Novolin^®R will be used to induce hypoglycemia.
Receives: Drug: SAR438544; Drug: insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to reach a smoothed blood glucose of 70 mg/dL after initial administration of investigational medicinal product

    Measured: Day 1

Secondary outcomes (13)

  1. Assessment of PD parameter: continuous monitoring of blood glucose levels over a period of 6 hours post-dose

    Measured: Day 1

  2. Assessment of PD parameter: area under plasma concentration of the BG-time curve between IMP dosing and time t (BG-AUC0-t)

    Measured: Day 1

  3. Assessment of PD parameter: BG-maximum concentration (BG-Cmax)

    Measured: Day 1

  4. Assessment of PD parameter: BG-time to Cmax (BG-tmax)

    Measured: Day 1

  5. Assessment of PK parameter (recombinant glucagon and SAR438544): Cmax

    Measured: Day 1

  6. Assessment of PK parameter (recombinant glucagon and SAR438544): tmax

    Measured: Day 1

  7. Assessment of PK parameter (recombinant glucagon and SAR438544): tlast

    Measured: Day 1

  8. Assessment of PK parameter (recombinant glucagon and SAR438544): terminal half-life

    Measured: Day 1

  9. Assessment of PK parameter (recombinant glucagon and SAR438544): area under curve from zero time until the last measurable concentration (AUClast)

    Measured: Day 1

  10. Assessment of PK parameter (recombinant glucagon and SAR438544): AUC

    Measured: Day 1

  11. Assessment of PK parameter (recombinant glucagon and SAR438544): partial AUCs (AUC0-t)

    Measured: Day 1

  12. Number of patients with adverse events

    Measured: Day 1 to Day 7 (+/- 1 day)

  13. Time to reach a smoothed blood glucose of 90 mg/dL after initial administration of investigational medicinal product

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2015 (estimated)
  2. Study startApr 2016
  3. Primary completionNov 2016 (estimated)
  4. Study completionNov 2016 (estimated)

Resources

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
Crossover
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02635243
Sponsor's protocol ID
PDY14452
Other IDs
U1111-1172-1152
Status last verified
Sep 2016
First submitted
16 Dec 2015
Last updated
2 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR438544, r-glucagon and insulin in people with Type 1 Diabetes Mellitus, run by Sanofi.

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 14 inclusion and 17 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: withdrawn, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Time to reach a smoothed blood glucose of 70 mg/dL after initial administration of investigational medicinal product (time frame: Day 1). 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 NCT02635243.

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 Sep 2016.

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