- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01318070
Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment with pioglitazone as well as diet and exercise therapies.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0).
- Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2).
- Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (*rounded off to the first decimal place).
- Was receiving specific diet and exercise (if any) therapies during the observation period.
Exclusion Criteria:
- Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0).
- Had a history or symptoms of cardiac failure.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
|
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Andre navne:
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Andre navne:
|
Eksperimentel: Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
|
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Andre navne:
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Andre navne:
|
Aktiv komparator: Pioglitazone (15mg or 30mg ) QD
|
Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ændring fra baseline i glykosyleret hæmoglobin (uge 12).
Tidsramme: Baseline og uge 12.
|
Ændringen i værdien af glycosyleret hæmoglobin (koncentrationen af glucose bundet til hæmoglobin som en procentdel af det absolutte maksimum, der kan bindes) opsamlet i uge 12 og glycosyleret hæmoglobin opsamlet ved baseline.
|
Baseline og uge 12.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ændring fra baseline i glykosyleret hæmoglobin (uge 8).
Tidsramme: Baseline og uge 8.
|
Ændringen i værdien af glycosyleret hæmoglobin (koncentrationen af glucose bundet til hæmoglobin som en procentdel af det absolutte maksimum, der kan bindes) opsamlet i uge 8 og glycosyleret hæmoglobin opsamlet ved baseline.
|
Baseline og uge 8.
|
Ændring fra baseline i glykosyleret hæmoglobin (uge 2).
Tidsramme: Baseline og uge 2.
|
Ændringen i værdien af glycosyleret hæmoglobin (koncentrationen af glucose bundet til hæmoglobin som en procentdel af det absolutte maksimum, der kan bindes) opsamlet i uge 2 og glycosyleret hæmoglobin opsamlet ved baseline.
|
Baseline og uge 2.
|
Ændring fra baseline i glykosyleret hæmoglobin (uge 4).
Tidsramme: Baseline og uge 4.
|
Ændringen i værdien af glycosyleret hæmoglobin (koncentrationen af glucose bundet til hæmoglobin som en procentdel af det absolutte maksimum, der kan bindes) opsamlet i uge 4 og glycosyleret hæmoglobin opsamlet ved baseline.
|
Baseline og uge 4.
|
Change From Baseline in Fasting Plasma Glucose (Week 2).
Tidsramme: Baseline and Week 2.
|
The change between the value of fasting plasma glucose collected at week 2 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 2.
|
Change From Baseline in Fasting Plasma Glucose (Week 4).
Tidsramme: Baseline and Week 4.
|
The change between the value of fasting plasma glucose collected at week 4 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 4.
|
Change From Baseline in Fasting Plasma Glucose (Week 8).
Tidsramme: Baseline and Week 8.
|
The change between the value of fasting plasma glucose collected at week 8 and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 8.
|
Change From Baseline in Fasting Plasma Glucose (Week 12).
Tidsramme: Baseline and Week 12.
|
The change between the value of fasting plasma glucose collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.
|
Baseline and Week 12.
|
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
Tidsramme: Baseline and Week 12.
|
The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline.
Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal.
|
Baseline and Week 12.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Professor, Diabetes and Endocrine Division, Department of Medicine, Kawasaki Medical School
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Pioglitazon
- Alogliptin
Andre undersøgelses-id-numre
- SYR-322/CCT-004
- UMIN000001382 (Registry Identifier: UMIN-CTR)
- JapicCTI-080590 (Registry Identifier: JapicCTI)
- U1111-1118-4073 (Registry Identifier: WHO)
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