Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea (JAS)

9. september 2012 opdateret af: Sung-Chen Liu

Efficacy of Adding Sitagliptin or Pioglitazone to Patients With Type 2 Diabetes Insufficiently Controlled With Metformin and Sulfonylurea

This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective, open-label, randomized, parallel, 24-week study. Inclusion criteria: type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks. > 20 years old; A1C:> 7.0 % and < 11% Exclusion criteria: insulin use within 12 weeks of the screening visit, any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) > 2.5 times the upper limit of normal (ULN), current or prepare to pregnancy and lactation.

Primary Purpose:

compare the change in hemoglobin A1c and the proportion of patients achieving A1C < 7% between the 2 groups

Secondary Purposes:

  1. Changes in fasting plasma glucose, high sensitive C-reactive protein (hsCRP)
  2. Homeostasis model assessment-β cell function(HOMA-β) will be calculated to assess changes in β-cell function and HOMA-insulin resistance(HOMA-IR)to assess changes in insulin resistance
  3. Body weight change, proportion of side effects

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 10449
        • Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Type 2 diabetes patients who were treated with stable doses of sulfonylurea and metformin to their half maximally dose (sulfonylureas > half maximal dose, and metformin > 1500 mg/d) for > 10 weeks
  • > 20 years old
  • A1C: > 7.0 % and < 11%

Exclusion Criteria:

  • Insulin use within 12 weeks of the screening visit
  • Any contraindications for use of sitagliptin or pioglitazone, impaired renal function (serum creatinine > 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase levels > 2.5 times the upper limit of normal
  • Current or prepare to pregnancy and lactation

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: sitagliptin
add sitagliptin100mg/d to pre-study OADs
Medicin: Sitagliptin
add sitagliptin100mg/d to pre-study OADs
Andre navne:
  • Januvia
Aktiv komparator: pioglitazone
add pioglitazone 30mg/d to pre-study OADs
Medicin: pioglitazone
add pioglitazone 30mg/d to pre-study OADs
Andre navne:
  • actos

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change in Glycosylated Hemoglobin (A1C)
Tidsramme: 24 weeks
A1C change from baseline to 24 weeks
24 weeks
Baseline A1C
Tidsramme: Baseline
baseline A1C
Baseline
The Percentages of Patient Achieving an A1C <7%
Tidsramme: 24 weeks
The percentages of patient achieving an A1C <7% at endpoint
24 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Fasting Plasma Glucose
Tidsramme: 24 weeks
fasting serum sugar change from baseline to 24 weeks
24 weeks
Changes in High Sensitive C-reactive Protein
Tidsramme: 24 weeks
fasting high sensitive serum C-reactive protein change from baseline to 24 weeks
24 weeks
Changes in Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Tidsramme: 24 weeks
HOMA-IR change from baseline to 24 weeks
24 weeks
Body Weight Change
Tidsramme: 24 weeks
body weight change from baseline to 24 weeks
24 weeks
Percentages of Patients With Total Adverse Events (AE)
Tidsramme: 24 weeks
percentages of total adverse events
24 weeks
Change in Fasting Total-cholesterol
Tidsramme: 24 weeks
Total-cholesterol change from baseline to 24 weeks
24 weeks
Change in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
Tidsramme: 24 weeks
LDL-C change from baseline to 24 weeks
24 weeks
Change in Fasting Triglycerides(TG)
Tidsramme: 24 weeks
TG change from baseline to 24 weeks
24 weeks
Change in Fasting High-density Lipoprotein Cholesterol(HDL-C)
Tidsramme: 24 weeks
HDL-C change from baseline to 24 weeks
24 weeks
Change in Fasting Plasma Alanine-aminotransferase (ALT)
Tidsramme: 24 weeks
ALT change from baseline to 24 weeks
24 weeks
Percentages of Patients With Mild to Moderate Hypoglycemia
Tidsramme: 24 weeks
Incidence of mild to moderate hypoglycemia after treatment
24 weeks
Percentages of Patients With Edema
Tidsramme: 24 weeks
proportion of edema after treatment
24 weeks
Percentages of Patients With Gastrointestinal Adverse Events
Tidsramme: 24 weeks
Proportion of Gastrointestinal adverse events after treatment
24 weeks
Percentages of Patients With Nasopharyngitis
Tidsramme: 24 weeks
Proportion of Nasopharyngitis after treatment
24 weeks
Percentages of Patients With Severe Hypoglycemia
Tidsramme: 24 weeks
Proportion of severe hypoglycemia after treatment
24 weeks
Baseline Fasting Plasma Glucose
Tidsramme: baseline
Baseline fasting plasma glucose
baseline
Baseline High Sensitive C-reactive Protein
Tidsramme: baseline
Baseline high sensitive C-reactive Protein
baseline
Baseline Homoeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Tidsramme: Baseline HOMA-IR
Baseline HOMA-IR
Baseline HOMA-IR
Baseline Alanine-aminotransferase (ALT)
Tidsramme: Baseline
Baseline alanine-aminotransferase
Baseline
Baseline Body Weight
Tidsramme: Baseline
Baseline body weight
Baseline
Baseline Total Cholesterol
Tidsramme: Baseline
Baseline Total cholesterol
Baseline
Baseline Triglyceride (TG)
Tidsramme: Baseline
Baseline TG
Baseline
Baseline Low-density Lipoprotein Cholesterol (LDL-C)
Tidsramme: Baseline
Baseline LDL-C
Baseline
Baseline High-density Lipoprotein Cholesterol (HDL-C)
Tidsramme: Baseline
Baseline HDL-C
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sung-Chen Liu

Samarbejdspartnere

Mackay Memorial Hospital

Efterforskere

  • Ledende efterforsker: Sung-Chen Liu, MD, Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital

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

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. april 2012

Datoer for studieregistrering

Først indsendt

2. september 2010

Først indsendt, der opfyldte QC-kriterier

2. september 2010

Først opslået (Skøn)

3. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2012

Sidst verificeret

1. september 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 09MMHIS047

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 .

Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med Sitagliptin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in El Salvador

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner