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Type 2 Diabetes MellitusPhase 1NCT03414736

A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period

A Phase 1 study testing SAR425899 in people with Type 2 Diabetes Mellitus, run by Sanofi at 3 sites 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 Objectives: Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
SAR425899
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesUnited States
Study dates
19 Jan 2018to 5 Oct 2018
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.
  • Patients who are motivated to lose weight.

Who cannot join

  • Type 1 diabetes mellitus.
  • Body mass index <27 kg/m2.
  • Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) >7.0%.
  • Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.
  • Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.
  • Uncontrolled hypertension.
Show all 13Show fewer
  • Laboratory findings at the time of screening: amylase and/or lipase >2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase >1.5 ULN, total bilirubin >1.5 ULN, serum creatinine levels ≥1.5 mg/dL [males]. ≥1.4 mg/dL [females], screening calcitonin ≥20 pmol/m, fasting serum triglycerides >400 mg/dL.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
  • History of weight loss surgery.
  • History of pancreatitis or pancreatectomy.
  • Pregnant or lactating women.
  • Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
  • 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

3 sites in 1 country.

United States3 sites

  • Investigational Site Number 8400001

    Austin, Texas, 78744

  • Investigational Site Number 8400003

    Knoxville, Tennessee, 37920

  • Investigational Site Number 8400002

    Saint Paul, Minnesota, 55144

Other trials in United States

About this study

Official title: A Randomized, Comparative, Open Label Study to Assess the Safety and Tolerability of 3-arm, Parallel, Repeated Subcutaneous Dose Regimens of SAR425899 in Overweight to Obese Subjects and T2DM Patients Not Requiring Anti-diabetic Pharmacotherapy, With an Optional 6-month Safety Extension Period

Primary Objectives:

  • Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).
  • Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs.
Read more

Secondary Objectives:

Main study and 6-month study extension period:

To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:

  • The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).
  • Safety and tolerability.
Read the detailed description

Main study: The maximum study duration is approximately 12 weeks per patient (up-to 3-week screening period, 8-week treatment period, 3-day post treatment follow-up period).

Six-month study extension period: The maximum study duration is approximately 9 months (up-to 3-week screening period, 8-month treatment period, 3-day post treatment follow-up period).

Being tested
SAR425899
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.

  • SAR425899Drug

    Pharmaceutical form: Solution

    Route of administration: Subcutaneous

Study groups in NCT03414736
Study groupRoleWhat they receive
Cohort 1ExperimentalDaily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.
Receives: Drug: SAR425899
Cohort 2ExperimentalWeekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.
Receives: Drug: SAR425899
Cohort 3ExperimentalWeekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.
Receives: Drug: SAR425899

What is being measured

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

  1. Frequency of gastrointestinal (GI) adverse events (AEs)

    Relative frequency of GI AEs

    Measured: Main study: Up to week 8; Six-month study extension period: Up to month 8

  2. Frequency of GI AEs

    Absolute frequency of GI AEs

    Measured: Main study: Up to week 8; Six-month study extension period: Up to month 8

  3. Frequency of GI AEs

    Severity of GI AEs

    Measured: Main study: Up to week 8; Six-month study extension period: Up to month 8

Secondary outcomes (4)

  1. Change in body weight

    Change in body weight from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

    Measured: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

  2. Change in fasting plasma glucose (FPG)

    Change in FPG from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

    Measured: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

  3. Change in hemoglobin A1c (HbA1c)

    Change in HbA1c from baseline to week 8 for the main study and from baseline to month 8 for the study extension period.

    Measured: Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

  4. Adverse events (AEs)

    Number of AEs

    Measured: Main study: up to week 8; Six-month extension period: up to month 8

Timeline

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

  1. First posted30 Jan 2018
  2. Study start19 Jan 2018
  3. Primary completion5 Oct 2018
  4. Study completion5 Oct 2018

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03414736
Sponsor's protocol ID
TDR15516
Other IDs
U1111-1205-1368
Status last verified
Apr 2022
First submitted
17 Jan 2018
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR425899 in people with Type 2 Diabetes Mellitus, run by Sanofi at 3 sites 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 2 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 3 sites 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?

Frequency of gastrointestinal (GI) adverse events (AEs) (time frame: Main study: Up to week 8; Six-month study extension period: Up to month 8). The study lists 3 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 NCT03414736.

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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