- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02765204
A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes
9. desember 2016 oppdatert av: Uppsala University
The purpose of this study is to evaluate if Dapagliflozin has direct effect on alpha cell glucagon release.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
15
Fase
- Fase 4
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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Uppsala, Sverige, 75185
- Dept of Medical Sciences Uppsala University Hospital
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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
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Males and females aged 18 - 75.
Female subjects must meet all of the following criteria:
- Not breastfeeding
- Negative pregnancy test result (human chorionic gonadotropin, beta subunit [hCG]) at Visit 0 (screening) (not applicable to hysterectomized females).
- If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice one of the following highly effective birth control methods during the entire duration of the study:
i. Diaphragm or partner use of condom in combination with combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Oral
- Intravaginal
- Transdermal ii. Diaphragm or partner use of condom in combination with progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable
- Implantable iii. Placement of an intrauterine device iv. Placement of an intrauterine hormone-releasing system v. Bilateral tubal occlusion vi. Vasectomised partner (provided that the partner is the sole sexual partner of the female subject and that the vasectomised partner has received medical assessment of the surgical success) vii. Sexual abstinence (defined as refraining from heterosexual intercourse) d) Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication
- BMI 20 - 35.
- Clinical T2D diagnosis at least 6 months prior to enrolment.
- Metformin treatment, with stable dose for at least 1 month.
- HbA1c 55 - 86 mmol/mol (7,2-10 % DCCT).
Exclusion Criteria:
- History or sign of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- Clinical diagnosis of Type 1 diabetes mellitus and/or history of diabetic ketoacidosis or positive Glutamic Acid Decarboxylase Autoantibodies test (GAD antibodies test).
- Patients treated with antipsychotics, systemic glucocorticoids, neuropsychiatric stimulants, antidepressants with sympathetic activity, beta blockers or other pharmaceuticals rendering patient unfit for study participation as judged by the investigator.
- Patients treated with antidiabetic medications other than Metformin.
- Patients with any other endocrine disease except substituted hypothyroidism.
- Significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
- Patients with impaired liver or kidney function (eGFR < 60).
- Known or suspected history of significant drug abuse.
- History of alcohol abuse or excessive intake of alcohol as judged by investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator.
- Plasma donation within one month of screening or any blood donation or significant blood loss (> 400 ml) during the 3 months prior to screening.
- Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.
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: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: DS-D-DG
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
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Eksperimentell: DS-DG-D
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
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Eksperimentell: D-DG-DS
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
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Eksperimentell: D-DS-DG
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
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Eksperimentell: DG-D-DS
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
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Eksperimentell: DG-DS-D
The arm label indicates the order of the given treatments in this crossover designed study (DS=Dapagliflozin and Saxagliptin, D=Dapagliflozin, DG=Dapagliflozin and Glucose).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change in plasma glucagon levels from baseline to 0.5 hour after single-dose administration of drug.
Tidsramme: At start and 0.5 hour after the start of each intervention
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Washout period of 2-6 weeks between the interventions
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At start and 0.5 hour after the start of each intervention
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Change in plasma glucagon levels from baseline to 1 hour after single-dose administration of drug.
Tidsramme: At start and 1 hour after the start of each intervention
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At start and 1 hour after the start of each intervention
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Change in plasma glucagon levels from baseline to 2 hours after single-dose administration of drug.
Tidsramme: At start and 2 hours after the start of each intervention
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At start and 2 hours after the start of each intervention
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Change in plasma glucagon levels from baseline to 3 hours after single-dose administration of drug.
Tidsramme: At start and 3 hours after the start of each intervention
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At start and 3 hours after the start of each intervention
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Change in plasma glucagon levels from baseline to 5 hours after single-dose administration of drug.
Tidsramme: At start and 5 hours after the start of each intervention
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At start and 5 hours after the start of each intervention
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Change in plasma glucagon levels from baseline to 5.5 hours after single-dose administration of drug.
Tidsramme: At start and 5.5 hours after the start of each intervention
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At start and 5.5 hours after the start of each intervention
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Change in plasma glucagon levels from baseline to 6 hours after single-dose administration of drug.
Tidsramme: At start and 6 hours after the start of each intervention
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At start and 6 hours after the start of each intervention
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Change in plasma glucagon levels from baseline to 7 hours after single-dose administration of drug.
Tidsramme: At start and 7 hours after the start of each intervention
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At start and 7 hours after the start of each intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jan W Eriksson, MD PhD, Uppsala University
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.
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
1. mars 2016
Primær fullføring (Faktiske)
1. desember 2016
Studiet fullført (Faktiske)
1. desember 2016
Datoer for studieregistrering
Først innsendt
14. april 2016
Først innsendt som oppfylte QC-kriteriene
4. mai 2016
Først lagt ut (Anslag)
6. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. desember 2016
Sist bekreftet
1. desember 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 2
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehemmere
- Inkretiner
- Sodium-Glucose Transporter 2-hemmere
- Dipeptidyl-Peptidase IV-hemmere
- Dapagliflozin
- Saksagliptin
Andre studie-ID-numre
- ESR-15-11421
- 2015-005549-30 (EudraCT-nummer)
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. .
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