A Study of ASP1941 in Combination With Insulin in Patients With Type 1 Diabetes Mellitus
5. mars 2019 oppdatert av: Astellas Pharma Inc
Phase III Study of ASP1941 Double-blind, Parallel-group Study in Combination With Insulin in Patients With Type 1 Diabetes Mellitus
The objective of this study is to confirm efficacy of ASP1941 based on the changes in HbA1c and to assess its safety in subjects with type 1 diabetes mellitus receiving ASP1941 once daily in combination with insulin for 24 weeks.
This study will also assess the safety/efficacy of long-term treatment (52 weeks).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study consists of two parts.
In Part 1, ASP1941 or placebo will be administered orally in a blind manner.
In Part 2, the long-term safety and efficacy of ASP1941 will be evaluated in patients who have participated in the study and completed the Part 1.
Studietype
Intervensjonell
Registrering (Faktiske)
175
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Aichi, Japan
- Site JP00005
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Aichi, Japan
- Site JP00028
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Chiba, Japan
- Site JP00003
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Chiba, Japan
- Site JP00013
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Chiba, Japan
- Site JP00035
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Fukuoka, Japan
- Site JP00023
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Fukuoka, Japan
- Site JP00022
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Fukuoka, Japan
- Site JP00031
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Gunma, Japan
- Site JP00011
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Gunma, Japan
- Site JP00002
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Hiroshima, Japan
- Site JP00006
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Hokkaido, Japan
- Site JP00033
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Hokkaido, Japan
- Site JP00034
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Hyogo, Japan
- Site JP00021
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Ibaraki, Japan
- Site JP00009
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Ibaraki, Japan
- Site JP00010
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Kanagawa, Japan
- Site JP00004
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Kanagawa, Japan
- Site JP00015
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Kanagawa, Japan
- Site JP00016
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Mie, Japan
- Site JP00019
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Nagasaki, Japan
- Site JP00008
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Nagasaki, Japan
- Site JP00024
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Nagasaki, Japan
- Site JP00025
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Nagasaki, Japan
- Site JP00032
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Niigata, Japan
- Site JP00026
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Osaka, Japan
- Site JP00036
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Osaka, Japan
- Site JP00029
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Osaka, Japan
- Site JP00020
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Saitama, Japan
- Site JP00012
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Shizuoka, Japan
- Site JP00018
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Shizuoka, Japan
- Site JP00017
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Tochigi, Japan
- Site JP00001
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Tokushima, Japan
- Site JP00030
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Tokyo, Japan
- Site JP00014
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Toyama, Japan
- Site JP00027
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Yamaguchi, Japan
- Site JP00007
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- The subject has been diagnosed with type 1 diabetes mellitus
- The subject has been receiving insulin therapy for the treatment of diabetes mellitus.
- The subject has not switched from an insulin product to another insulin product or switched between continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI).
- The subject has an HbA1c value between 7.5% and 11.0% and the difference of HbA1c value is within ± 2.0%.
- The subject has a fasting blood C-peptide level < 0.6 ng/mL.
- The subject has a body mass index (BMI) between 20.0 kg/m2 and 35.0 kg/m2.
Exclusion Criteria:
- The subject has type 2 diabetes mellitus.
- The subject has participated in a clinical study or post marketing study of another drug or medical equipment within 12 weeks (84 days) before providing written informed consent, or is currently participating in such a study.
- The subject has received treatment with ASP1941 (ipragliflozin) or participated in a clinical study of ASP1941 (excluding subjects who discontinued before the investigational period).
- The subject participated in this study previously.
- The subject has received a hypoglycemic agent other than insulin or an α-glucosidase inhibitor.
- The subject has proliferative retinopathy (except for those who have undergone photocoagulation etc. and whose symptoms are stable).
- The subject has experienced severe hypoglycemia.
- The subject has experienced diabetic ketoacidosis.
- The subject has chronic disease that requires the continuous use of corticosteroids, immunosuppressants, etc.
- The subject has symptomatic urinary tract infection or symptomatic genital infection.
- The subject has a history of recurrent urinary tract infection or recurrent genital infection.
- The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or another serious heart disease.
- The subject has a concomitant malignant tumor or a history of malignant tumor
- The subject has a history of an allergy to ASP1941 (ipragliflozin) and/or similar drugs (drugs possessing SGLT2 inhibitory action).
- The subject has psychiatric disorder that is inappropriate for participation in the study.
- The subject has drug addiction or alcohol abuse.
- The subject has severe infection or serious trauma, or is perioperative.
- The subject has a history of medically significant renal disease such as renovascular occlusive disease, nephrectomy and/or renal transplant.
- The subject has any symptoms of dysuria, anuria, oliguria, or urinary retention.
- The subject has severe renal impairment or end-stage renal failure requiring dialysis.
- The subject has an Aspartate Aminotransferase and/or Alanine Aminotransferase value that exceeds 2 times, or a total bilirubin value that exceeds 1.5 times the upper limit of the reference range.
- The subject has uncontrolled severe hypertension.
- The subject has serious gastrointestinal disease or a history of operation for serious gastrointestinal disease.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Part 1 ASP1941
ASP1941 will be administered for 24 weeks under double blind conditions.
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Oral administration once daily
Andre navn:
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
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Placebo komparator: Part 1 Placebo
Placebo will be administered for 24 weeks under double blind conditions.
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Oral administrering én gang daglig
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
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Eksperimentell: Part 2 ASP1941
ASP1941 will be administered for 28 weeks under open label conditions.
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Oral administration once daily
Andre navn:
Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline in HbA1c
Tidsramme: Baseline and Week 24 (end of treatment period 1)
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Baseline and Week 24 (end of treatment period 1)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sikkerhet vurdert etter forekomst av uønskede hendelser
Tidsramme: Frem til uke 56
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Frem til uke 56
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Change from baseline in HbA1c
Tidsramme: Baseline and up to Week 56
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Baseline and up to Week 56
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Change from baseline in Fasting plasma glucose
Tidsramme: Baseline and up to Week 56
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Baseline and up to Week 56
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Change from baseline in self-monitored blood glucose level
Tidsramme: Baseline and up to Week 56
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Baseline and up to Week 56
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Change from baseline in leptin
Tidsramme: Baseline and up to Week 52
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Baseline and up to Week 52
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Change from baseline in glycoalbumin
Tidsramme: Baseline and up to Week 52
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Baseline and up to Week 52
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Change from baseline in adiponectin
Tidsramme: Baseline and up to Week 52
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Baseline and up to Week 52
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Change from baseline in glucagon
Tidsramme: Baseline and up to Week 52
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Baseline and up to Week 52
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Change from baseline in number of units of insulin administered concomitantly
Tidsramme: Baseline and up to Week 56
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Comprehensively assessed by basal insulin daily dose, bolus insulin daily dose and total insulin daily dose.
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Baseline and up to Week 56
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Change from baseline in body weight
Tidsramme: Baseline and up to Week 56
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Baseline and up to Week 56
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Change from baseline in waist circumference
Tidsramme: Baseline and up to Week 52
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Baseline and up to Week 52
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Safety assessed by sitting blood pressure
Tidsramme: Up to Week 56
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Up to Week 56
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Safety assessed by sitting pulse rate
Tidsramme: Up to Week 56
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Up to Week 56
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Safety assessed by standard 12-lead electrocardiogram
Tidsramme: Up to Week 56
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Up to Week 56
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Safety assessed by laboratory tests: Hematology
Tidsramme: Up to Week 56
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Up to Week 56
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Safety assessed by laboratory tests: Biochemistry
Tidsramme: Up to Week 56
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Up to Week 56
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Safety assessed by laboratory tests: Urinalysis
Tidsramme: Up to Week 56
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Up to Week 56
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. august 2016
Primær fullføring (Faktiske)
22. juli 2017
Studiet fullført (Faktiske)
15. mars 2018
Datoer for studieregistrering
Først innsendt
27. juli 2016
Først innsendt som oppfylte QC-kriteriene
7. september 2016
Først lagt ut (Anslag)
13. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i immunsystemet
- Autoimmune sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 1
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Sodium-Glucose Transporter 2-hemmere
- Ipragliflozin
Andre studie-ID-numre
- 1941-CL-6002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development.
Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD-delingstidsramme
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Tilgangskriterier for IPD-deling
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data.
The research proposal is reviewed by an Independent Research Panel.
If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .