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Type 2 Diabetes MellitusPhase 3NCT03761134

Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea

A Phase 3 study testing sotagliflozin (SAR439954), metformin and sulfonylurea in people with Type 2 Diabetes Mellitus, run by Sanofi at 40 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Primary Objective: To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on metformin alone or metformin in combination with sulfonylurea. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
sotagliflozin (SAR439954), metformin and sulfonylurea
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
377 participants
Where
40 sitesChina
Study dates
30 Nov 2018to 29 Apr 2020
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chinese patients with T2D diagnosed for at least 1 year, who are treated with diet/exercise and:
  • Metformin alone at a stable dose ( ≥1500 mg/day or maximum tolerated dose [documented]) for at least 8 weeks before the screening visit OR
  • Metformin in combination with sulfonylurea (≥ half maximum-labelled dose or maximum tolerated dose [documented]) each at a stable dose for at least 8 weeks before the screening visit.
  • Signed written informed consent.

Who cannot join

  • Age <18 years at the screening visit.
  • Type 1 diabetes.
  • Hemoglobin A1c <7% or >10.5% measured by the central laboratory at the screening visit.
  • Fasting plasma glucose >15 mmol/L (>270 mg/dL) measured by the central laboratory at the screening visit and confirmed by a repeat test (>15 mmol/L [>270 mg/dL]) before randomization.
  • Body mass index (BMI) ≤20 or >45 kg/m2 at the screening visit.
  • Women of childbearing potential not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
Show all 26Show fewer
  • Previous use of any antidiabetic drug other than metformin and sulphonylurea within the 12 weeks prior to the screening visit.
  • Previous use of any types of insulin for >1 month within 12 months before screening.
  • History of gastric surgery including history of gastric banding or inflammatory bowel disease within 3 years prior to the screening visit.
  • History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar coma within 12 weeks prior to the screening visit.
  • History of serious hypoglycemia resulting in unconsciousness, seizure or hospitalization within 6 months prior to the screening visit.
  • Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic blood pressure DBP (DBP)).
  • History of hypertensive emergency within 12 weeks prior to the screening visit.
  • Patients with severe anemia, severe cardiovascular (CV) (including congestive heart failure New York Heart Association (NYHA) IV), respiratory, hepatic, neurological, psychiatric, or active malignant tumor or other major systemic disease or patients with short life expectancy that, according to Investigator, will preclude their safe participation in this study, or will make implementation of the protocol or interpretation of the study results difficult.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal (ULN) laboratory range.
  • Total bilirubin >1.5 times the ULN (except in case of Gilbert's syndrome).
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application, nasal spray, or inhaled forms) for more than 10 consecutive days within 90 days prior to the screening visit.
  • Patient who has taken other investigational drugs or prohibited therapy for this study within 12 weeks or 5 half-lives prior to the screening visit, whichever is longer.
  • Use of a selective SGLT2 inhibitor (eg, canagliflozin, dapagliflozin, or empagliflozin) within 3 months prior to the screening visit.
  • Pregnant (confirmed by serum pregnancy test at the screening visit) or breastfeeding women.
  • Patients with severe renal disease as defined by an eGFR of <30 mL/min/1.73m² at the screening visit, based on the 4 variable Modification of Diet in Renal Disease (MDRD) equation.
  • Patients with contraindication to metformin as per local labelling.
  • Patients with contraindication to sulfonylurea as per local labelling if the patient is taking metformin with sulfonylurea.
  • Patient unwilling or unable to perform self-monitoring of blood glucose (SMBG), complete the patient diary, or comply with study visits and other study procedures as required per protocol.
  • Patients unable to consume at least 50% of the standard meal during the MMTT at baseline (Day 1, Visit 3) before randomization.
  • 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

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • Investigational Site Number 1560039

    Baotou, 014010

  • Investigational Site Number 1560040

    Baotou, 014010

  • Investigational Site Number 1560001

    Beijing, 100029

  • Investigational Site Number 1560038

    Beijing, 100191

  • Investigational Site Number 1560035

    Cangzhou, 061000

  • Investigational Site Number 1560020

    Changchun, 130033

  • Investigational Site Number 1560012

    Changchun, 130041

  • Investigational Site Number 1560011

    Changsha, 410011

  • Investigational Site Number 1560021

    Changzhou, 213003

  • Investigational Site Number 1560024

    Chongqing, 400010

  • Investigational Site Number 1560028

    Dalian, 116011

  • Investigational Site Number 1560010

    Dalian, 116033

  • Investigational Site Number 1560036

    Dalian

  • Investigational Site Number 1560030

    Fuzhou, 354200

  • Investigational Site Number 1560032

    Guangzhou, 510080

  • Investigational Site Number 1560027

    Guangzhou, 510180

  • Investigational Site Number 1560041

    Hangzhou

  • Investigational Site Number 1560046

    Harbin, 150001

  • Investigational Site Number 1560009

    Hefei, 230001

  • Investigational Site Number 1560025

    Hohhot, 010017

  • Investigational Site Number 1560026

    Huai'an, 223300

  • Investigational Site Number 1560006

    Jinan, 250013

  • Investigational Site Number 1560033

    Kunming

  • Investigational Site Number 1560034

    Luoyang

  • Investigational Site Number 1560014

    Nanjing, 210011

  • Investigational Site Number 1560018

    Pingxiang, 337055

  • Investigational Site Number 1560003

    Shanghai, 200072

  • Investigational Site Number 1560004

    Shanghai, 201700

  • Investigational Site Number 1560013

    Shanghai

  • Investigational Site Number 1560005

    Shenyang, 110004

  • Investigational Site Number 1560019

    Shijiazhuang

  • Investigational Site Number 1560017

    Suzhou, 215004

  • Investigational Site Number 1560022

    Wuhan, 430014

  • Investigational Site Number 1560023

    Wuxi, 214023

  • Investigational Site Number 1560015

    Xiangtan

  • Investigational Site Number 1560043

    Yuncheng, 044000

  • Investigational Site Number 1560042

    Zhengzhou, 450003

  • Investigational Site Number 1560007

    Zhenjiang, 212001

  • Investigational Site Number 1560037

    Zhongshan

  • Investigational Site Number 1560016

    Zhuzhou, 412007

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Chinese Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone or Metformin in Combination With Sulfonylurea

Primary Objective:

To demonstrate the superiority of sotagliflozin dose 1 versus placebo on hemoglobin A1c (HbA1c) reduction in Chinese patients with type 2 diabetes (T2D) who have inadequate glycemic control on metformin alone or metformin in combination with sulfonylurea.

Read more

Secondary Objectives:

To compare sotagliflozin dose 1 versus placebo for change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT), change in fasting plasma glucose (FPG), and change in body weight.

  • To compare sotagliflozin dose 2 versus placebo for change in HbA1c, change in 2-hour PPG following a MMTT, change in FPG, and change in body weight.
  • To compare sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo for change in systolic blood pressure (SBP) for all patients, and change in SBP for patients with baseline SBP ≥130 mmHg.
  • To evaluate the safety of sotagliflozin dose 2 and sotagliflozin dose 1 versus placebo.
Read the detailed description

Total study duration is up to 30 weeks, including a screening period consisting of a screening phase of up to 2 weeks and a 2-week single-blind placebo run-in phase, a 24-week double-blind treatment period, and a 2-week post-treatment follow-up visit period to collect safety information.

Being tested
sotagliflozin (SAR439954), placebo, metformin, sulfonylurea
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

  • placeboDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • metforminDrug

    Pharmaceutical form: tablet

    Route of administration: oral

  • sulfonylureaDrug

    Pharmaceutical form: tablet

    Route of administration: oral

Study groups in NCT03761134
Study groupRoleWhat they receive
Sotagliflozin dose 1ExperimentalSotagliflozin dose 1, given as two (2) dose 2 tablets, once daily, before the first meal of the day
Receives: Drug: sotagliflozin (SAR439954); Drug: metformin; Drug: sulfonylurea
Sotagliflozin dose 2ExperimentalSotagliflozin dose 2, given as 1 sotagliflozin dose 2 tablet and 1 sotagliflozin-matching placebo tablet (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Receives: Drug: sotagliflozin (SAR439954); Drug: placebo; Drug: metformin; Drug: sulfonylurea
PlaceboPlacebo comparatorTwo sotagliflozin-matching placebo tablets (identical to sotagliflozin dose 2 in appearance), once daily, before the first meal of the day
Receives: Drug: placebo; Drug: metformin; Drug: sulfonylurea

What is being measured

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

  1. Change in hemoglobin A1c (HbA1c)

    Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 1)

    Measured: Baseline to Week 24

Secondary outcomes (7)

  1. Change in 2-hour postprandial glucose (PPG) following a mixed meal tolerance test (MMTT)

    Absolute change from baseline to week 24 in 2-hour PPG following a MMTT (for sotagliflozin dose1 and 2)

    Measured: Baseline to Week 24

  2. Change in fasting plasma glucose (FPG)

    Absolute change from baseline to week 24 in FPG (for sotagliflozin dose 1 and 2)

    Measured: Baseline to Week 24

  3. Change in body weight

    Absolute change from baseline to week 24 in body weight (for sotagliflozin dose1 and 2)

    Measured: Baseline to Week 24

  4. Change in HbA1c

    Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose 2)

    Measured: Baseline to Week 24

  5. Change in systolic blood pressure (SBP) for all patients

    Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose 1 and 2)

    Measured: Baseline to Week 12

  6. Change in SBP for patients with baseline SBP ≥130 mmHg

    Absolute change from baseline to week 12 in SBP for patients with baseline SBP ≥130 mmHg (for sotagliflozin dose 1 and 2)

    Measured: Baseline to Week 12

  7. Adverse events

    Number of patients with adverse events

    Measured: Up to Week 24

Timeline

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

  1. First posted3 Dec 2018
  2. Study start30 Nov 2018
  3. Primary completion29 Apr 2020
  4. Study completion29 Apr 2020

Why it stopped: Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03761134
Sponsor's protocol ID
EFC15193
Other IDs
U1111-1195-6143
Status last verified
Apr 2022
First submitted
29 Nov 2018
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sotagliflozin (SAR439954), metformin and sulfonylurea in people with Type 2 Diabetes Mellitus, run by Sanofi at 40 sites in China.

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 26 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: stopped early, 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 40 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 stopped early (reason given: Sanofi ended collaboration with Lexicon for Sotagliflozin. In China no regulatory pathway to transfer sponsorship during the conduct of ongoing studies.). Results are not available in the source record.

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?

Change in hemoglobin A1c (HbA1c) (time frame: Baseline to Week 24). 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 NCT03761134.

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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