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Safety and Efficacy in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 (Linagliptin) vs. Placebo, Insulin Background Inclusive

2014년 5월 15일 업데이트: Boehringer Ingelheim

Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive

to determine safety, efficacy and tolerability of BI 1356 versus placebo

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

133

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 뉴질랜드
      • Auckland, 뉴질랜드
        • 1218.43.64001 Boehringer Ingelheim Investigational Site
      • Christchurch, 뉴질랜드
        • 1218.43.64003 Boehringer Ingelheim Investigational Site
      • Takpuna, 뉴질랜드
        • 1218.43.64004 Boehringer Ingelheim Investigational Site
      • Tauranga, 뉴질랜드
        • 1218.43.64002 Boehringer Ingelheim Investigational Site
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국
        • 1218.43.10027 Boehringer Ingelheim Investigational Site
    • California
      • Chula Vista, California, 미국
        • 1218.43.10011 Boehringer Ingelheim Investigational Site
      • Riverside, California, 미국
        • 1218.43.10006 Boehringer Ingelheim Investigational Site
      • Whittier, California, 미국
        • 1218.43.10021 Boehringer Ingelheim Investigational Site
    • Florida
      • Pembroke Pines, Florida, 미국
        • 1218.43.10013 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, 미국
        • 1218.43.10009 Boehringer Ingelheim Investigational Site
    • Georgia
      • Decatur, Georgia, 미국
        • 1218.43.10018 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, 미국
        • 1218.43.10022 Boehringer Ingelheim Investigational Site
    • Louisiana
      • Shreveport, Louisiana, 미국
        • 1218.43.10015 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City, Missouri, 미국
        • 1218.43.10016 Boehringer Ingelheim Investigational Site
    • New York
      • Bronx, New York, 미국
        • 1218.43.10004 Boehringer Ingelheim Investigational Site
      • Great Neck, New York, 미국
        • 1218.43.10003 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Winston-Salem, North Carolina, 미국
        • 1218.43.10020 Boehringer Ingelheim Investigational Site
    • Ohio
      • Delaware, Ohio, 미국
        • 1218.43.10019 Boehringer Ingelheim Investigational Site
      • Mentor, Ohio, 미국
        • 1218.43.10008 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, 미국
        • 1218.43.10005 Boehringer Ingelheim Investigational Site
      • Carlisle, Pennsylvania, 미국
        • 1218.43.10007 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, 미국
        • 1218.43.10001 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Aiken, South Carolina, 미국
        • 1218.43.10025 Boehringer Ingelheim Investigational Site
    • Texas
      • Austin, Texas, 미국
        • 1218.43.10023 Boehringer Ingelheim Investigational Site
      • Austin, Texas, 미국
        • 1218.43.10024 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, 미국
        • 1218.43.10014 Boehringer Ingelheim Investigational Site
      • Lufkin, Texas, 미국
        • 1218.43.10017 Boehringer Ingelheim Investigational Site
    • Washington
      • Tacoma, Washington, 미국
        • 1218.43.10010 Boehringer Ingelheim Investigational Site
  • 우크라이나
      • Kharkiv, 우크라이나
        • 1218.43.38004 Boehringer Ingelheim Investigational Site
      • Kharkov, 우크라이나
        • 1218.43.38003 Boehringer Ingelheim Investigational Site
      • Kharkov, 우크라이나
        • 1218.43.38006 Boehringer Ingelheim Investigational Site
      • Kiev, 우크라이나
        • 1218.43.38005 Boehringer Ingelheim Investigational Site
      • Lugansk, 우크라이나
        • 1218.43.38007 Boehringer Ingelheim Investigational Site
      • Ternopil, 우크라이나
        • 1218.43.38008 Boehringer Ingelheim Investigational Site
      • Zaporizhzhya, 우크라이나
        • 1218.43.38002 Boehringer Ingelheim Investigational Site
  • 이스라엘
      • Afula, 이스라엘
        • 1218.43.97008 Boehringer Ingelheim Investigational Site
      • Ashkelon, 이스라엘
        • 1218.43.97005 Boehringer Ingelheim Investigational Site
      • Haifa, 이스라엘
        • 1218.43.97003 Boehringer Ingelheim Investigational Site
      • Jerusalem, 이스라엘
        • 1218.43.97004 Boehringer Ingelheim Investigational Site
      • Jerusalem, 이스라엘
        • 1218.43.97009 Boehringer Ingelheim Investigational Site
      • Kfar Saba, 이스라엘
        • 1218.43.97002 Boehringer Ingelheim Investigational Site
      • Nahariya, 이스라엘
        • 1218.43.97007 Boehringer Ingelheim Investigational Site
      • Safed, 이스라엘
        • 1218.43.97001 Boehringer Ingelheim Investigational Site
      • Tel Aviv, 이스라엘
        • 1218.43.97006 Boehringer Ingelheim Investigational Site
  • 호주
      • Adelaide, SA, 호주
        • 1218.43.61005 Boehringer Ingelheim Investigational Site
      • Herston, QLD, 호주
        • 1218.43.61002 Boehringer Ingelheim Investigational Site
    • New South Wales
      • Gosford, New South Wales, 호주
        • 1218.43.61009 Boehringer Ingelheim Investigational Site
    • Queensland
      • Auchenflower, Queensland, 호주
        • 1218.43.61010 Boehringer Ingelheim Investigational Site
      • Kippa Ring, Queensland, 호주
        • 1218.43.61006 Boehringer Ingelheim Investigational Site
    • Victoria
      • Reservoir, Victoria, 호주
        • 1218.43.61007 Boehringer Ingelheim Investigational Site
      • Richmond, Victoria, 호주
        • 1218.43.61011 Boehringer Ingelheim Investigational Site
  • 홍콩
      • Hong Kong, 홍콩
        • 1218.43.85201 Boehringer Ingelheim Investigational Site
      • New Territories, 홍콩
        • 1218.43.85203 Boehringer Ingelheim Investigational Site

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:

  • Male and female patients with type 2 diabetes and with glomerular filtration rate (GFR) <30 ml/min, who are not on chronic dialysis.
  • Insufficient glycemic control (hemoglobin A1c (HbA1c) between 7.0% and 10.0%)
  • Age 18 or over and not older than 80 years

Exclusion criteria:

  • Treatment with any other anti diabetic drug other than insulin and/or sulphonylurea within 3 months prior to informed consent
  • Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent
  • Unstable or acute congestive heart failure

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: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: BI 1356
patient to receive a tablet containing BI 1356 once daily
의약품: BI 1356
BI 1356 dosed once daily
위약 비교기: placebo
patient to receive a tablet identical to BI 1356 once daily
의약품: placebo
placebo matching BI 1356 taken once daily

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
HbA1c Change From Baseline at Week 12
기간: Baseline and Week 12
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline continuous HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 12

2차 결과 측정

결과 측정
측정값 설명
기간
HbA1c Change From Baseline at Week 52
기간: Baseline and Week 52
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 52
HbA1c Change From Baseline at Week 18
기간: Baseline and Week 18
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 18
HbA1c Change From Baseline at Week 24
기간: Baseline and Week 24
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 24
HbA1c Change From Baseline at Week 30
기간: Baseline and Week 30
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 30 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 30
HbA1c Change From Baseline at Week 36
기간: Baseline and Week 36
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 36 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 36
HbA1c Change From Baseline at Week 42
기간: Baseline and Week 42
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 42 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 42
HbA1c Change From Baseline at Week 48
기간: Baseline and Week 48
HbA1c is measured as a Percent. Thus, this change from baseline reflects the Week 48 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for continuous baseline HbA1c , creatinine clearance at baseline and previous anti-diabetic medication.
Baseline and Week 48
The Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 52 Weeks of Treatment
기간: Baseline and Week 52
The percentage of patients with an HbA1c value below 6.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=6.5%
Baseline and Week 52
The Occurrence of a Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 52 Weeks of Treatment
기간: Baseline and Week 52
The percentage of patients with an HbA1c value below 7.0% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF). Analysis was only performed on patients with baseline HbA1c>=7%.
Baseline and Week 52
Percentage of Patients With HbA1c Lowering by 0.5% at Week 52
기간: Baseline and Week 52
The percentage of patients with an HbA1c reduction from baseline >=0.5% at week 52 was calculated for each treatment arm. Non-completers were imputed as failure (NCF).
Baseline and Week 52
FPG Change From Baseline at Week 12
기간: Baseline and Week 12
This change from baseline reflects the week 12 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Baseline and Week 12
FPG Change From Baseline at Week 18
기간: Baseline and Week 18
Model includes treatment, continuous baseline FPG , creatinine clearance , HbA1c and background of anti diabetic drugs
Baseline and Week 18
FPG Change From Baseline at Week 24
기간: Baseline and Week 24
This change from baseline reflects the week 24 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 24
FPG Change From Baseline at Week 30
기간: Baseline and Week 30
This change from baseline reflects the week 30 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 30
FPG Change From Baseline at Week 36
기간: Baseline and Week 36
This change from baseline reflects the week 36 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 36
FPG Change From Baseline at Week 42
기간: Baseline and Week 42
This change from baseline reflects the week 42 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 42
FPG Change From Baseline at Week 48
기간: Baseline and Week 48
This change from baseline reflects the week 48 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 48
FPG Change From Baseline at week52
기간: Baseline and Week 52
This change from baseline reflects the week 52 FPG minus the baseline FPG. Means are treatment adjusted for continuous baseline FPG , baseline creatinine clearance , baseline HbA1c and background of anti diabetic drugs
Baseline and Week 52
Change From Baseline in Antidiabetic Background Therapy Dose at 52 Weeks Compared to Baseline and Over Time
기간: Baseline and Week 52
Number of patients with at least one change in daily dose, determined by at least a 10% increase in insulin.
Baseline and Week 52
Clinically Relevant Drug-related Abnormalities for Blood Chemistry, Pulse Rate, Laboratory Parameters and ECG
기간: first administration of randomised treatment to ....
Clinically relevant drug-related abnormalities for blood chemistry, pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
first administration of randomised treatment to ....

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

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

유용한 링크

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

2008년 12월 1일

기본 완료 (실제)

2011년 1월 1일

연구 등록 날짜

최초 제출

2008년 12월 1일

QC 기준을 충족하는 최초 제출

2008년 12월 1일

처음 게시됨 (추정)

2008년 12월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 5월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 5월 15일

마지막으로 확인됨

2014년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1218.43
  • 2008-001569-27 (EudraCT 번호: EudraCT)

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. .

제2형 당뇨병에 대한 임상 시험

  • Postgraduate Institute of Medical Education and...
    완전한
    2형 간신증후군 (Type2 HRS)
    Type 2 HRS에서 Terlipressin과 Noradrenaline의 안전성과 효능 및 예측반응인자
    인도

BI 1356에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Bangladesh

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다