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Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice

23. januar 2019 oppdatert av: Takeda

A Prospective, Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice

The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or alogliptin FDCs, in standard clinical practice.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The drug being studied in this study is called alogliptin and alogliptin FDCs. Alogliptin and alogliptin FDCs is being researched to treat people who have diabetes mellitus type 2. This study will look at the glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2.

The study enrolled 593 patients. Alogliptin and alogliptin FDCs will be prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study).

This multi-center study will be conducted in China. The overall duration of study for observation will be approximately 6 months, or up to loss to follow-up or death, whichever occurs first. Participants will make multiple visits to the clinic as per regular doctor's appointments.

Studietype

Observasjonsmessig

Registrering (Faktiske)

593

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Hong Kong
      • Sai Ying Pun, Hong Kong
      • Sha Tin, Hong Kong
  • Kina
    • Beijing
      • Beijing, Beijing, Kina
    • Hubei
      • Wuhan, Hubei, Kina
    • Liaoning
      • Dalian, Liaoning, Kina
      • Shenyang, Liaoning, Kina
    • Shandong
      • Jinan, Shandong, Kina
      • Qingdao, Shandong, Kina
      • Tai'an, Shandong, Kina
      • Taian, Shandong, Kina
    • Tianjin
      • Tianjin, Tianjin, Kina

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.

Beskrivelse

Inclusion Criteria:

  1. Has a diagnosis of T2DM.
  2. Has made the decision, along with his/her treating physician, to begin treatment with alogliptin or alogliptin fixed-dose combinations (FDCs).
  3. Has an glycated hemoglobin (HbA1c) value recorded at most 3 months before initiation of treatment with alogliptin or alogliptin FDCs.
  4. Alogliptin or alogliptin FDCs is prescribed according to the approved label for China and Hong Kong.

Exclusion Criteria:

  1. Has gestational diabetes or type 1 diabetes mellitus.
  2. Has used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of alogliptin or alogliptin FDCs treatment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
Legemiddel: Alogliptin
Alogliptin tabletter
Legemiddel: Alogliptin FDC With Pioglitazone
Alogliptin FDC with pioglitazone tablets
Legemiddel: Alogliptin FDC With Metformin
Alogliptin FDC with metformin tablets

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Endring fra baseline i glykosylert hemoglobin (HbA1c) nivå ved måned 6
Tidsramme: Grunnlinje og måned 6
Endringen i verdien av glykosylert hemoglobin (konsentrasjonen av glukose bundet til hemoglobin som en prosent av det absolutte maksimum som kan bindes) samlet ved måned 6 i forhold til baseline. Glykosylert hemoglobin (HbA1c) som et diagnostisk kriterium for diabetes mellitus er ≥6,5 %. En negativ endring fra Baseline indikerer bedring.
Grunnlinje og måned 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
Tidsramme: Baseline and Month 6
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement.
Baseline and Month 6
Percentage of Participants With a Decrease in HbA1c Level by <7.0%
Tidsramme: Baseline and Month 6
Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.
Baseline and Month 6
Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
Tidsramme: Baseline and Month 6
Percentage of participants with a decrease of >0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%.
Baseline and Month 6
Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
Tidsramme: Baseline and Months 3 and 6
The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.
Baseline and Months 3 and 6
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
Tidsramme: Baseline and Months 3 and 6
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.
Baseline and Months 3 and 6
Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Tidsramme: Baseline up to Month 6
An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.
Baseline up to Month 6
Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs
Tidsramme: Months 3 and 6
Months 3 and 6
Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
Tidsramme: Months 3 and 6
Months 3 and 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Takeda

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)

22. desember 2016

Primær fullføring (Faktiske)

26. januar 2018

Studiet fullført (Faktiske)

26. januar 2018

Datoer for studieregistrering

Først innsendt

8. desember 2016

Først innsendt som oppfylte QC-kriteriene

8. desember 2016

Først lagt ut (Anslag)

12. desember 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Alogliptin-5009

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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