이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Efficacy of Alogliptin and With Pioglitazone in Patients With Type 2 Diabetes.

2013년 5월 23일 업데이트: Takeda

Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing SYR-322 Alone and Combination SYR-322 With Pioglitazone Versus Placebo on Postprandial Lipids in Subjects With Type 2 Diabetes

The purpose of this study is to compare the efficacy of Alogliptin, once daily (QD), taken by itself and with pioglitazone on postprandial lipid measures in type 2 diabetes.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

SYR-322 (alogliptin) is a selective, orally available inhibitor of dipeptidyl peptidase IV being developed as a treatment for type 2 diabetes mellitus. Dipeptidyl peptidase IV is the primary enzyme involved in the in vivo degradation of at least 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd. (Osaka, Japan). Pioglitazone HCl depends on the presence of insulin for its mechanism of action.

This study will assess the effects of alogliptin and alogliptin coadministered with pioglitazone HCl on postprandial lipid and lipoprotein metabolism in participants with type 2 diabetes. Individuals who participate in this study will be required to commit to a screening visit and up to 6 additional visits at the study center. Study participation is anticipated to be about 20 weeks (or approximately 5 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms. At 3 of the visits a meal will be served that must be eaten within 10 minutes.

연구 유형

중재적

등록 (실제)

71

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria

  • Diagnosis of type 2 diabetes
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Either failed treatment with diet and exercise for 3 months prior to Screening or has been receiving a stable dose of metformin, sulfonylurea, nateglinide, or repaglinide for more than 3 months prior to Screening.
  • Inadequate glycemic control as defined by glycosylated hemoglobin concentration between 6.5 and 9.0%, inclusive.
  • Fasting plasma glucose less than 13.3 mmol per L.
  • Fasting serum triglyceride level of 1.7 to 5.0 mmol per L, inclusive.
  • Has not been receiving any lipid-lowering therapy within 3 months prior to Screening or on a stable statin and/or ezetimibe therapy (same drug and dose) for at least 3 months.
  • Body mass index greater than 23 kg/m2 and less than 45 kg/m2.
  • If has regular use of other, non-excluded medications, must be on a stable dose for at least 4 weeks prior to Screening. Use of as needed prescription medications and over-the-counter medications is allowed at the discretion of the investigator.
  • Is to be Apolipoprotein E 3/3 or Apolipoprotein E 3/4 phenotype positive prior to baseline.

Exclusion Criteria

  • History of type 1 diabetes.
  • History of drug abuse (defined as illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per day) within the past 2 years.
  • Diastolic blood pressure greater than 100 mm Hg or a systolic blood pressure of greater than 160 mm Hg.
  • History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
  • Hemoglobin less than 120 g per L for males and less than100 g per L for females.
  • Alanine transaminase level greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
  • Serum creatinine level greater than 133 μmol per L.
  • Fasting total cholesterol greater than 6.5 mmol per L.
  • New York Heart Association heart failure of any Class (I-IV) regardless of therapy.
  • History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening.
  • History of acute metabolic diabetic complications.
  • History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
  • History of infection with human immunodeficiency virus.
  • History of diabetic gastro paresis.
  • History of gastric bypass surgery.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약 QD
의약품: Placebo
Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
다른 이름들:
  • 악토스
  • SYR-322
  • AD-4833
실험적: 알로글립틴 25mg QD
의약품: Alogliptin
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 16 weeks.
다른 이름들:
  • SYR-322
  • SYR110322
실험적: Alogliptin 25 mg QD + Pioglitazone 30 mg QD
의약품: Alogliptin and Pioglitazone
Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 16 weeks.
다른 이름들:
  • 악토스
  • SYR-322
  • SYR110322
  • AD-4833
  • 알로글립틴

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 16.
기간: Baseline and Week 16.
The change in postprandial (after eating a meal) incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC (0-8h)) postdose at week 16 relative to baseline.
Baseline and Week 16.

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Postprandial Incremental Area Under the Curve for Total Triglycerides at Week 4.
기간: Baseline and Week 4.
The change in postprandial incremental area under the plasma concentration-time curve from 0 to 8 hours (AUC(0-8h)) postdose at week 4 relative to baseline.
Baseline and Week 4.
Change From Baseline in Postprandial Incremental Area Under the Curve Changes for Lipid Parameters.
기간: Baseline, Week 4 and Week 16.
The change in postprandial incremental area under the plasma concentration-time curve for very-low-density lipoprotein (VLDL) cholesterol, VLDL triglycerides, VLDL2 cholesterol, VLDL2 triglycerides, chylomicron cholesterol, chylomicron triglycerides, intermediate-density lipoprotein (IDL) cholesterol, and IDL triglycerides from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Incremental Area Under the Curve for Lipoprotein Parameters.
기간: Baseline, Week 4 and Week 16.
Postprandial incremental area under the curve changes for very-low-density lipoprotein (VLDL) Apo B-48, VLDL Apo B 100, VLDL2 Apo B-48, VLDL2 Apo B 100, chylomicron Apo B-48, chylomicron Apo B 100, and intermediate density lipoprotein (IDL) Apo B-48, IDL Apo B 100, and triglyceride-rich remnant (TRR) lipoproteins from 0 to 8 hours postdose at week 4 and week 16 relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon-like Peptide-1 (GLP-1)
기간: Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucose
기간: Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Insulin
기간: Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Postprandial Changes Over Time From Baseline for Glucagon
기간: Baseline, Week 4 and Week 16.
Postprandial changes over time at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Glycosylated Hemoglobin
기간: Baseline, Week 8 and Week 16.
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 each week indicated relative to baseline.
Baseline, Week 8 and Week 16.
Change From Baseline in Fasting Plasma Glucose
기간: Baseline, Week 4, Week 8 and Week 16.
The change in fasting plasma glucose collected at each week indicated relative to baseline.
Baseline, Week 4, Week 8 and Week 16.
Change From Baseline in Postprandial C-Peptide
기간: Baseline, Week 4 and Week 16.
The change in postprandial C-peptide collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Postprandial Proinsulin
기간: Baseline, Week 4 and Week 16.
The change in postprandial proinsulin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in High-sensitive C-reactive Protein (Hs-CRP)
기간: Baseline, Week 4 and Week 16.
The change in hs-CRP collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Adiponectin
기간: Baseline, Week 4 and Week 16.
The change in adiponectin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Vascular Cell Adhesion Molecule (VCAM)
기간: Baseline, Week 4 and Week 16.
The change in VCAM collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Anti-Intercellular Adhesion Molecule (ICAM)
기간: Baseline, Week 4 and Week 16.
The change in ICAM collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in e-Selectin
기간: Baseline, Week 4 and Week 16.
The change in e-Selectin collected at each week indicated relative to baseline.
Baseline, Week 4 and Week 16.
Change From Baseline in Endothelial Function Through Pulse Wave Tonometry
기간: Baseline and Week 16.
Pulse wave tonometry performed before the meal and 2 hours postmeal using one recording consisting of 15 to 20 sequentially recorded radial artery waveforms collected at each assessment.
Baseline and Week 16.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Takeda

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2007년 7월 1일

기본 완료 (실제)

2009년 12월 1일

연구 완료 (실제)

2009년 12월 1일

연구 등록 날짜

최초 제출

2008년 4월 4일

QC 기준을 충족하는 최초 제출

2008년 4월 9일

처음 게시됨 (추정)

2008년 4월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 5월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 5월 23일

마지막으로 확인됨

2013년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SYR-322_301
  • 2007-000486-38 (EudraCT 번호)
  • U1111-1113-2081 (레지스트리 식별자: WHO)
  • NL22649.029.08 (레지스트리 식별자: CCMO)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

진성 당뇨병에 대한 임상 시험

Placebo에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Cameroon

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다