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Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Diet and Exercise

21. april 2022 opdateret af: Sanofi

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin as Monotherapy in Chinese Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Diet and Exercise

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 diet and exercise.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

276

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina, 100044
        • Investigational Site Number 1560001
      • Beijing, Kina, 100730
        • Investigational Site Number 1560003
      • Beijing, Kina, 100730
        • Investigational Site Number 1560004
      • Beijing, Kina, 101200
        • Investigational Site Number 1560002
      • Changchun, Kina, 130021
        • Investigational Site Number 1560007
      • Changchun, Kina, 130041
        • Investigational Site Number 1560008
      • Chongqing, Kina, 400010
        • Investigational Site Number 1560024
      • Guangzhou, Kina, 510120
        • Investigational Site Number 1560022
      • Guangzhou, Kina, 510150
        • Investigational Site Number 1560033
      • Guangzhou, Kina
        • Investigational Site Number 1560021
      • Harbin, Kina, 150001
        • Investigational Site Number 1560029
      • Hohhot, Kina, 010017
        • Investigational Site Number 1560009
      • Huai'An, Kina, 223300
        • Investigational Site Number 1560014
      • Huzhou, Kina
        • Investigational Site Number 1560019
      • Jining, Kina
        • Investigational Site Number 1560025
      • Jining, Kina
        • Investigational Site Number 1560027
      • Luoyang, Kina
        • Investigational Site Number 1560012
      • Pingxiang, Kina, 337055
        • Investigational Site Number 1560013
      • Qingdao, Kina, 266011
        • Investigational Site Number 1560034
      • Qingdao, Kina, 266042
        • Investigational Site Number 1560026
      • Shanghai, Kina, 200040
        • Investigational Site Number 1560017
      • Shanghai, Kina
        • Investigational Site Number 1560016
      • Shijiazhuang, Kina
        • Investigational Site Number 1560006
      • Tianjin, Kina, 300211
        • Investigational Site Number 1560005
      • Wuhan, Kina, 430000
        • Investigational Site Number 1560035
      • Xuzhou, Kina, 221006
        • Investigational Site Number 1560023
      • Yinchuan, Kina, 750004
        • Investigational Site Number 1560028
      • Yuncheng, Kina, 044000
        • Investigational Site Number 1560032
      • Zhuzhou, Kina, 412007
        • Investigational Site Number 1560015

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria :

  • Chinese patients with Type 2 Diabetes who are treated with diet and exercise only during the 12 weeks prior to screening
  • Signed written informed consent.

Exclusion criteria:

  • Age <18 years at the screening visit.
  • Type 1 diabetes.
  • Hemoglobin A1c <7% or >10% 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.
  • Previous use of any antidiabetic medication(s) for >4 months at any time or previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes).
  • Previous use of any antidiabetic drug within 12 weeks prior to the screening visit.
  • 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.
  • Mean of 3 separate blood pressure measurements >180 mmHg (SBP) or >100 mmHg (diastolic blood pressure (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.
  • 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.
  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sotagliflozin dosis 1
Sotagliflozin dosis 1, givet som to (2) dosis 2 tabletter, én gang dagligt, før dagens første måltid
Medicin: sotagliflozin (SAR439954)

Lægemiddelform: tablet

Indgivelsesvej: oral
Eksperimentel: Sotagliflozin dosis 2
Sotagliflozin dosis 2, givet som 1 sotagliflozin dosis 2 tablet og 1 sotagliflozin-matchende placebotablet (identisk med sotagliflozin dosis 2 i udseende), én gang dagligt før dagens første måltid
Medicin: sotagliflozin (SAR439954)

Lægemiddelform: tablet

Indgivelsesvej: oral

Medicin: placebo

Lægemiddelform: tablet

Indgivelsesvej: oral
Placebo komparator: Placebo
To sotagliflozin-matchende placebotabletter (i udseende identisk med sotagliflozin-dosis 2), én gang dagligt før dagens første måltid
Medicin: placebo

Lægemiddelform: tablet

Indgivelsesvej: oral

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in hemoglobin A1c (HbA1c)
Tidsramme: Baseline to Week 24
Absolute change from baseline to week 24 in HbA1c (for sotagliflozin dose1)
Baseline to Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring i 2-timers postprandial glucose (PPG) efter en blandet måltid tolerancetest (MMTT)
Tidsramme: Baseline til uge 24
Absolut ændring fra baseline til uge 24 i 2-timers PPG efter en MMTT (for sotagliflozin dosis 1 og 2)
Baseline til uge 24
Ændring i kropsvægt
Tidsramme: Baseline til uge 24
Absolut ændring fra baseline til uge 24 i kropsvægt (for sotagliflozin dosis 1 og 2)
Baseline til uge 24
Ændring i HbA1c
Tidsramme: Baseline til uge 24
Absolut ændring fra baseline til uge 24 i HbA1c (for sotagliflozin dosis 2)
Baseline til uge 24
Uønskede hændelser
Tidsramme: Op til uge 24
Antal patienter med bivirkninger
Op til uge 24
Change in fasting plasma glucose (FPG)
Tidsramme: Baseline to Week 24
Absolute change from baseline to week 24 in FPG (for sotagliflozin dose1 and 2)
Baseline to Week 24
Change in systolic blood pressure (SBP) for all patients
Tidsramme: Baseline to Week 12
Absolute change from baseline to week 12 in SBP for all patients (for sotagliflozin dose1 and 2)
Baseline to Week 12
Change in SBP for patients with baseline SBP ≥130 mmHg
Tidsramme: Baseline to Week 12
Absolute change from baseline to week 12 in SBP patients with baseline SBP ≥130 mmHg (for sotagliflozin dose1 and 2)
Baseline to Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. november 2018

Primær færdiggørelse (Faktiske)

24. april 2020

Studieafslutning (Faktiske)

24. april 2020

Datoer for studieregistrering

Først indsendt

29. november 2018

Først indsendt, der opfyldte QC-kriterier

29. november 2018

Først opslået (Faktiske)

3. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EFC15194
  • U1111-1195-6181 (Anden identifikator: UTN)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes mellitus

Kliniske forsøg med sotagliflozin (SAR439954)

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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