- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02529449
Pharmacodynamics, Pharmacokinetics, and Safety of ASP1941 in Patients With Type 1 Diabetes Mellitus
14. marts 2019 opdateret af: Astellas Pharma Inc
A Phase 2, Clinical Pharmacological Study of ASP1941 in Japanese Patients With Type 1 Diabetes Mellitus
The objective of this study is to assess pharmacodynamics, pharmacokinetics, and safety of ASP1941 in patients with type 1 diabetes mellitus when administered once daily (q.d.) for 2 weeks.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
43
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Aichi, Japan
- Site JP00006
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Fukuoka, Japan
- Site JP00002
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Gunma, Japan
- Site JP00009
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Ibaraki, Japan
- Site JP00001
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Kanagawa, Japan
- Site JP00008
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Kanagawa, Japan
- Site JP00005
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Okayama, Japan
- Site JP00003
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Osaka, Japan
- Site JP00004
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Osaka, Japan
- Site JP00010
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Osaka, Japan
- Site JP00011
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Tokyo, Japan
- Site JP00007
-
-
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
20 år til 74 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
At the time of obtaining informed consent:
- Subject is diagnosed with type 1 diabetes mellitus and has been treated with insulin therapy for at least 52 weeks (364 days).
- Subject is able to be admitted to the site as scheduled.
- Subject is able to record in Patient's diary from the first study drug dose in observation period until the day before the end of post observation.
At screening period:
- Subject has an HbA1c (NGSP) value of between 7.5% and 10.0%. If subject has an HbA1c value of between 7.3% and 10.2% (out of the reference range), HbA1c may be re-measured only once within the allowance range in screening period. Re-measured HbA1c (NGSP) value will be adopted for the determination.
- Subject has been receiving insulin therapy at daily doses (instructed by a doctor) within a ±20% range for at least 12weeks (83days) prior to the start of screening.
- Subject has a fasting serum C-peptide level ≤0.5 ng/mL at screening.
- Subject receives treatments for complications (except for transient diseases such as a cold) that, in the investigator's or sub-investigator's opinion, need not to be changed during the period from the start of screening to the end of the treatment period.
- Subject has body mass index (BMI) value of 20.0 to 35.0 kg/m2 at screening.
Exclusion Criteria:
At the time of obtaining informed consent:
- Subject has type 2 diabetes mellitus.
- Subject has participated or has been participating in a clinical study or a post marketing study of another drug or medical equipment within 12 weeks (84 days) prior to obtaining informed consent.
- Subject has received ASP1941 (ipragliflozin) with the exception of placebo.
At screening period:
- Subject has proliferative retinopathy (subjects with stable condition after photocoagulation etc. may be enrolled in the study).
- Subject has developed hypoglycemia unawareness (requires help of a third person) or severe hypoglycemia (diabetic coma, precoma, or convulsion) within 12 weeks (84 days) prior to the start of screening.
- Subject has developed diabetic ketoacidosis within 12 weeks (84 days) prior to the start of screening.
- Subject has chronic disease(s) which require the continuous use of corticosteroids or immunosuppressants (oral administration, injection, inhalation, or suppository).
- Subject has received hypoglycemic agent(s) other than insulin within 12 weeks (83 days) prior to the start of screening.
- Subject with perioperative, severe infection or serious injury.
- Subject whose serum creatinine value exceeds the upper limit of normal range at screening.
- Subject has a urinary albumin/urinary creatinine ratio>300 mg/g in urinalysis at screening.
- Subject has a history of clinically significant renal disease(s) such as renovascular occlusive disease, nephrectomy, and/or renal transplant.
- Subject has AST and ALT >2 ×ULN or T-Bil >1.5 × ULN at screening, or has a history of serious hepatic diseases.
- Subject presents with symptoms of dysuria, anuria, oliguria and urinary retention.
- Subject has a history of recurrent urinary tract infections and recurrent genital infections (developed 3 times or more within 24 weeks (168 days) prior to the start of screening).
- Subject has urinary tract infection or genital infection with subjective symptoms.
- Subject has a history of angina unstable, myocardial infarction, angioplasty, and serious heart disease (NYHA Class II-IV) within 24 weeks (168 days) prior to the start of screening, or has complications of heart disease that, in the investigator's or sub-investigator's opinion, may interfere with the evaluation of safety of ASP1941.
- Subject has uncontrolled blood pressure (systolic blood pressure≥160 mmHg or diastolic blood pressure≥100 mmHg in the supine position after a 5-minute rest at screening ).
- Subject has serious gastrointestinal disease or a history of serious gastrointestinal operation.
- Subject has malignant tumors concomitantly (subject may be enrolled in the study if the subject has a history of a malignant tumor which has not recurred without any treatment within 5 years prior to the start of screening).
- Subject has psychiatric disorder that makes the subject unsuitable for study participation.
- Subject has drug addiction or alcohol abuse.
- Subject has a history of drug allergies.
- Subject is unable to adhere to any of the compliance such as hospital visits and dose instruction specified in this study, or does not agree with it.
- Subject has donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days prior to the start of screening.
- Subject has any condition that, in the investigator's or sub-investigator's opinion, makes the subject unsuitable for study participation.
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: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
en gang dagligt
|
Mundtlig
|
Eksperimentel: ASP1941 Low dose group
once daily
|
Mundtlig
Andre navne:
|
Eksperimentel: ASP1941 Middle dose group
once daily
|
Mundtlig
Andre navne:
|
Eksperimentel: ASP1941 High dose group
once daily
|
Mundtlig
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Daily profile of plasma glucose levels
Tidsramme: up to Day 14
|
up to Day 14
|
|
Area under the concentration-time curve (AUC) 0-24hr (AUC0-24h) of plasma glucose levels
Tidsramme: at Day -1, Day 1 and Day 14
|
at Day -1, Day 1 and Day 14
|
|
AUC0-3h of plasma glucose levels
Tidsramme: at Day -1, Day 1 and Day 14
|
at Day -1, Day 1 and Day 14
|
|
AUC0-4h of plasma glucose levels
Tidsramme: up to Day 14
|
up to Day 14
|
|
AUC0-10h of plasma glucose levels
Tidsramme: up to Day 14
|
up to Day 14
|
|
Fasting plasma glucose levels
Tidsramme: up to Day 21
|
up to Day 21
|
|
Glycoalbumin
Tidsramme: up to Day 21
|
up to Day 21
|
|
Urinary glucose excretion
Tidsramme: up to Day 14
|
up to Day 14
|
|
Urinary glucose excretion rate
Tidsramme: up to Day 14
|
up to Day 14
|
|
Urine volume
Tidsramme: up to Day 14
|
up to Day 14
|
|
Urinary glucose concentration
Tidsramme: up to Day 15
|
up to Day 15
|
|
Body weight
Tidsramme: up to Day 21
|
up to Day 21
|
|
Renal glucose clearance
Tidsramme: up to Day 14
|
up to Day 14
|
|
Plasma concentration of unchanged ASP1941
Tidsramme: up to Day 14
|
up to Day 14
|
|
Urinary concentration of unchanged ASP1941
Tidsramme: up to Day 14
|
up to Day 14
|
|
Pharmacokinetics (PK) parameter of ASP1941 in plasma: AUC from time 0 extrapolated to infinity (AUCinf)
Tidsramme: at Day 1
|
at Day 1
|
|
PK parameter of ASP1941 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
PK parameter of ASP1941 in plasma: AUC from the time of dosing to 24 hr (AUC0-24h)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
PK parameter of ASP1941 in plasma: Oral Clearance (CL/F)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
PK parameter of ASP1941 in plasma: Maximum concentration (Cmax)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
PK parameter of ASP1941 in plasma: Terminal Elimination Half-life (t1/2)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
PK parameter of ASP1941 in plasma: Time of the Maximum Concentration (tmax)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
PK parameter of ASP1941 in urine: Amount excreted in urine between time (Ae)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
PK parameter of ASP1941 in urine: % of the dose of excreted in urine (Ae%)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
PK parameter of ASP1941 in plasma and urine: Renal Clearance (CLr)
Tidsramme: at Day 1 and Day 14
|
at Day 1 and Day 14
|
|
Safety assessed by vital signs
Tidsramme: up to Day 21
|
Supine blood pressure and supine pulse rate
|
up to Day 21
|
Safety assessed by 12-lead electrocardiogram
Tidsramme: up to Day 21
|
up to Day 21
|
|
Safety assessed by laboratory tests
Tidsramme: up to Day 21
|
Hematology, biochemistry and urinalysis
|
up to Day 21
|
Safety assessed by self-monitored blood glucose levels
Tidsramme: up to Day 21
|
up to Day 21
|
|
Safety assessed by Adverse events
Tidsramme: up to Day 21
|
up to Day 21
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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)
1. september 2015
Primær færdiggørelse (Faktiske)
19. marts 2016
Studieafslutning (Faktiske)
19. marts 2016
Datoer for studieregistrering
Først indsendt
18. august 2015
Først indsendt, der opfyldte QC-kriterier
19. august 2015
Først opslået (Skøn)
20. august 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i immunsystemet
- Autoimmune sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 1
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Natrium-Glucose Transporter 2-hæmmere
- Ipragliflozin
Andre undersøgelses-id-numre
- 1941-CL-6001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
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 .
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Capillary Biomedical, Inc.AfsluttetDiabetes mellitus, type 1 | Type 1 diabetes | Type 1 diabetes mellitus | Diabetes mellitus, insulinafhængig, 1Australien
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