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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 januari 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

593

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Geneesmiddel: Alogliptine
Alogliptine-tabletten
Geneesmiddel: Alogliptin FDC With Pioglitazone
Alogliptin FDC with pioglitazone tablets
Geneesmiddel: Alogliptin FDC With Metformin
Alogliptin FDC with metformin tablets

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Verandering ten opzichte van de uitgangswaarde in het niveau van geglycosyleerd hemoglobine (HbA1c) in maand 6
Tijdsspanne: Basislijn en maand 6
De verandering in de waarde van geglycosyleerd hemoglobine (de concentratie van aan hemoglobine gebonden glucose als percentage van het absolute maximum dat kan worden gebonden) verzameld in maand 6 ten opzichte van de uitgangswaarde. Geglycosyleerd hemoglobine (HbA1c) als diagnostisch criterium van diabetes mellitus is ≥6,5%. Een negatieve verandering ten opzichte van de basislijn wijst op verbetering.
Basislijn en maand 6

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
Tijdsspanne: 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%
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Months 3 and 6
Months 3 and 6
Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
Tijdsspanne: Months 3 and 6
Months 3 and 6

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Takeda

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 december 2016

Primaire voltooiing (Werkelijk)

26 januari 2018

Studie voltooiing (Werkelijk)

26 januari 2018

Studieregistratiedata

Eerst ingediend

8 december 2016

Eerst ingediend dat voldeed aan de QC-criteria

8 december 2016

Eerst geplaatst (Schatting)

12 december 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 april 2019

Laatste update ingediend die voldeed aan QC-criteria

23 januari 2019

Laatst geverifieerd

1 januari 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Alogliptin-5009

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

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.

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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