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Type 2 Diabetes MellitusPhase 1NCT02940379

A Drug to Drug Interaction Study of Sotagliflozin With Midazolam and Metoprolol

A Phase 1 study testing sotagliflozin (SAR439954), midazolam and metoprolol in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam. Secondary Objective: To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
sotagliflozin (SAR439954), midazolam and metoprolol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Oct 2016to Dec 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female healthy subjects, between 18 and 55 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 between 18.0 and 30.0 kg/m^2, inclusive.
  • Normal vital signs, electrocardiogram (ECG), and laboratory parameters
  • Female subjects must use a double contraception method during the study, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include the use of one of the following contraceptive options: (1) condom; (2) diaphragm or cervical/vault cap; (3) spermicide in addition to the use of one of the following: a) Intrauterine device (IUD); b) Vasectomized partner; c) Sexual abstinence. Hormonal contraception is NOT acceptable in this study.

Who cannot join

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
  • Frequent headaches and/or migraine, recurrent nausea and/or vomiting.
  • Blood donation, any volume, within 2 months before inclusion.
  • Symptomatic postural hypotension.
  • Presence or history of drug hypersensitivity, allergic disease or asthma diagnosed and treated by a physician.
  • History or presence of drug or alcohol abuse.
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  • If female, pregnancy or breast-feeding.
  • 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; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. Any oral contraceptives during the screening period or for at least 15 days prior to the first dose of Period 1; any injectable contraceptives or hormonal intrauterine devices within 12 months prior to the first dose of Period 1; or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of Period 1.
  • Any contra-indications to metoprolol, according to the applicable labeling.
  • Any contra-indications to midazolam, according to the applicable labeling.
  • Any consumption of citrus (grapefruit, orange, etc.) or their juices within 5 days before inclusion.
  • Any history or presence of deep leg vein thrombosis or embolism or a recurrent or frequent appearance of deep leg vein thrombosis in first 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.

United States1 site

  • Investigational Site Number 840001

    Knoxville, Tennessee, 37920

Other trials in United States

About this study

Official title: A Two-cohort, Open-label, Fixed-sequence, Two-period, Two-treatment Pharmacokinetic Interaction Study of Repeated Oral Doses of Sotagliflozin on a Single Dose Cocktail of Metoprolol and Midazolam Used as Probe Substrates for CYP2D6 and CYP3A Activities, Respectively, in Healthy Subjects

Primary Objective:

To assess the effect of repeated once-daily oral doses of sotagliflozin on CYP2D6 and CYP3A activities using a CYP probe cocktail of metoprolol and midazolam.

Secondary Objective:

To assess the clinical and laboratory safety of sotagliflozin coadministered with the cocktail probes as compared to that of cocktail probes alone.

Read the detailed description

The total study duration per subject is up to 58 days.

Being tested
sotagliflozin (SAR439954), midazolam, metoprolol
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sotagliflozin (SAR439954)Drug

    Pharmaceutical form: tablet

    Route of administration: oral

  • midazolamDrug

    Pharmaceutical form: HCl syrup

    Route of administration: oral

  • metoprololDrug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT02940379
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 1 of Sotagliflozin plus cocktail) after 3 days
Receives: Drug: sotagliflozin (SAR439954); Drug: midazolam; Drug: metoprolol
Cohort 2ExperimentalParticipants will initially be given with treatment A (cocktail of metoprolol and midazolam) and then will start with treatment B (Dose 2 of Sotagliflozin plus cocktail) after 3 days
Receives: Drug: sotagliflozin (SAR439954); Drug: midazolam; Drug: metoprolol

What is being measured

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

  1. Assessment of midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC)

    Measured: Day 1 to Day 2 of Treatment A Period

  2. Assessment of midazolam PK parameter: AUC

    Measured: Day 11 to Day 12 of Treatment B Period

  3. Assessment of metoprolol PK parameter: AUC

    Measured: Day 1 to Day 3 of Treatment A Period

  4. Assessment of metoprolol PK parameter: AUC

    Measured: Day 11 to Day 13 of Treatment B Period

Secondary outcomes (12)

  1. Assessment of PK parameter: maximum plasma concentration (Cmax)

    Measured: Day 1 to Day 2 of Treatment A Period (midazolam)

  2. Assessment of PK parameter: Cmax

    Measured: Day 11 to Day 12 of Treatment B Period (midazolam)

  3. Assessment of PK parameter: Cmax

    Measured: Day 1 to Day 3 of Treatment A Period (metoprolol)

  4. Assessment of PK parameter: Cmax

    Measured: Day 11 to Day 13 of Treatment B Period (metoprolol)

  5. Assessment of PK parameter: time to reach Cmax (Tmax)

    Measured: Day 1 to Day 2 of Treatment A Period (midazolam)

  6. Assessment of PK parameter: Tmax

    Measured: Day 11 to Day 12 of Treatment B Period (midazolam)

  7. Assessment of PK parameter: Tmax

    Measured: Day 1 to Day 3 of Treatment A Period (metoprolol)

  8. Assessment of PK parameter: Tmax

    Measured: Day 11 to Day 13 of Treatment B Period (metoprolol)

  9. Assessment of PK parameter: terminal-half life (t1/2z)

    Measured: Day 1 to Day 2 of Treatment A Period (midazolam)

  10. Assessment of PK parameter: t1/2z

    Measured: Day 11 to Day 12 of Treatment B Period (midazolam)

  11. Assessment of PK parameter: t1/2z

    Measured: Day 1 to Day 3 of Treatment A Period (metoprolol)

  12. Assessment of PK parameter: t1/2z

    Measured: Day 11 to Day 13 of Treatment B Period (metoprolol)

Timeline

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

  1. First posted20 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02940379
Sponsor's protocol ID
INT14972
Other IDs
U1111-1184-8677
Status last verified
Apr 2022
First submitted
19 Oct 2016
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sotagliflozin (SAR439954), midazolam and metoprolol in people with Type 2 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 4 inclusion and 13 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 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. 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 midazolam pharmacokinetic (PK) parameter: Area under the curve (AUC) (time frame: Day 1 to Day 2 of Treatment A Period). 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 NCT02940379.

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.

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