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

30 Week Parallel Group Comparison Study of Linagliptin + Pioglitazone (5+15, 5+30 and 5+45 mg) qd Versus Respective Monotherapies, Followed by a Comparison of 5mg+30mg and 5mg+45mg Versus Respective Monotherapies in Type 2 Diabetes for up to 54 Weeks

2014년 10월 9일 업데이트: Boehringer Ingelheim

A Randomised, Double-blind Parallel Group Study to Compare the Efficacy and Safety of Initial Combination Therapy With Linagliptin 5 mg + Pioglitazone 15 mg, 30 mg, or 45 mg, vs. Monotherapy With Pioglitazone (15 mg, 30 mg, or 45 mg) or Linagliptin 5 mg Once Daily for 30 Weeks, Followed by a Blinded Trial Period on Linagliptin 5 mg + Pioglitazone 30 or 45 mg Versus Pioglitazone Monotherapy 30 or 45 mg or Linagliptin 5 mg for up to 54 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control on Diet and Exercise

The primary objective is to demonstrate superior glycaemic control (HbA1c reduction) after 30 weeks of linagliptin/pioglitazone (5/15, 5/30 and 5/45 mg) versus the respective individual monotherapies of pioglitazone (15 mg, 30 mg, or 45 mg, administered orally once daily), and linagliptin (5 mg, administered orally once daily). In addition, durability of treatment effect and safety under chronic treatment conditions will be investigated.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

936

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 독일
      • Bad Lauterberg / Harz, 독일
        • 1264.3.49001 Boehringer Ingelheim Investigational Site
      • Dietzenbach, 독일
        • 1264.3.49007 Boehringer Ingelheim Investigational Site
      • Dortmund, 독일
        • 1264.3.49002 Boehringer Ingelheim Investigational Site
      • Essen, 독일
        • 1264.3.49009 Boehringer Ingelheim Investigational Site
      • Hamburg, 독일
        • 1264.3.49003 Boehringer Ingelheim Investigational Site
      • Ingelheim, 독일
        • 1264.3.49012 Boehringer Ingelheim Investigational Site
      • Leipzig, 독일
        • 1264.3.49008 Boehringer Ingelheim Investigational Site
      • Mainz, 독일
        • 1264.3.49005 Boehringer Ingelheim Investigational Site
      • Offenbach, 독일
        • 1264.3.49010 Boehringer Ingelheim Investigational Site
      • Stuhr, 독일
        • 1264.3.49004 Boehringer Ingelheim Investigational Site
  • 라트비아
      • Daugavpils, 라트비아
        • 1264.3.37105 Boehringer Ingelheim Investigational Site
      • Daugavpils, 라트비아
        • 1264.3.37112 Boehringer Ingelheim Investigational Site
      • Daugavpils, 라트비아
        • 1264.3.37113 Boehringer Ingelheim Investigational Site
      • Jelgava, 라트비아
        • 1264.3.37110 Boehringer Ingelheim Investigational Site
      • Liepaja, 라트비아
        • 1264.3.37101 Boehringer Ingelheim Investigational Site
      • Ogre, 라트비아
        • 1264.3.37106 Boehringer Ingelheim Investigational Site
      • Riga, 라트비아
        • 1264.3.37104 Boehringer Ingelheim Investigational Site
      • Riga, 라트비아
        • 1264.3.37108 Boehringer Ingelheim Investigational Site
      • Riga, 라트비아
        • 1264.3.37109 Boehringer Ingelheim Investigational Site
      • Riga, 라트비아
        • 1264.3.37111 Boehringer Ingelheim Investigational Site
      • Talsi, 라트비아
        • 1264.3.37107 Boehringer Ingelheim Investigational Site
      • Tukums, 라트비아
        • 1264.3.37102 Boehringer Ingelheim Investigational Site
      • Valmiera, 라트비아
        • 1264.3.37103 Boehringer Ingelheim Investigational Site
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국
        • 1264.3.01026 Boehringer Ingelheim Investigational Site
      • Montgomery, Alabama, 미국
        • 1264.3.01021 Boehringer Ingelheim Investigational Site
      • Muscle Shoals, Alabama, 미국
        • 1264.3.01020 Boehringer Ingelheim Investigational Site
    • Arizona
      • Chandler, Arizona, 미국
        • 1264.3.01062 Boehringer Ingelheim Investigational Site
      • Mesa, Arizona, 미국
        • 1264.3.01064 Boehringer Ingelheim Investigational Site
    • California
      • Carmichael, California, 미국
        • 1264.3.01049 Boehringer Ingelheim Investigational Site
      • Chino, California, 미국
        • 1264.3.01078 Boehringer Ingelheim Investigational Site
      • Concord, California, 미국
        • 1264.3.01031 Boehringer Ingelheim Investigational Site
      • Lakewood, California, 미국
        • 1264.3.01037 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, 미국
        • 1264.3.01065 Boehringer Ingelheim Investigational Site
      • Norwalk, California, 미국
        • 1264.3.01006 Boehringer Ingelheim Investigational Site
      • Rancho Cucamonga, California, 미국
        • 1264.3.01001 Boehringer Ingelheim Investigational Site
      • San Diego, California, 미국
        • 1264.3.01059 Boehringer Ingelheim Investigational Site
      • Tarzana, California, 미국
        • 1264.3.01023 Boehringer Ingelheim Investigational Site
      • Tustin, California, 미국
        • 1264.3.01016 Boehringer Ingelheim Investigational Site
      • Valencia, California, 미국
        • 1264.3.01058 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, 미국
        • 1264.3.01083 Boehringer Ingelheim Investigational Site
    • Colorado
      • Denver, Colorado, 미국
        • 1264.3.01027 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Norwalk, Connecticut, 미국
        • 1264.3.01033 Boehringer Ingelheim Investigational Site
    • Florida
      • Boca Raton, Florida, 미국
        • 1264.3.01035 Boehringer Ingelheim Investigational Site
      • Clearwater, Florida, 미국
        • 1264.3.01015 Boehringer Ingelheim Investigational Site
      • Hialeah, Florida, 미국
        • 1264.3.01082 Boehringer Ingelheim Investigational Site
      • Jacksonville, Florida, 미국
        • 1264.3.01036 Boehringer Ingelheim Investigational Site
      • Longwood, Florida, 미국
        • 1264.3.01013 Boehringer Ingelheim Investigational Site
      • Miami, Florida, 미국
        • 1264.3.01038 Boehringer Ingelheim Investigational Site
      • Miami, Florida, 미국
        • 1264.3.01042 Boehringer Ingelheim Investigational Site
      • Miami, Florida, 미국
        • 1264.3.01079 Boehringer Ingelheim Investigational Site
      • Port Orange, Florida, 미국
        • 1264.3.01019 Boehringer Ingelheim Investigational Site
      • St. Cloud, Florida, 미국
        • 1264.3.01018 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, 미국
        • 1264.3.01009 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, 미국
        • 1264.3.01012 Boehringer Ingelheim Investigational Site
    • Georgia
      • Atlanta, Georgia, 미국
        • 1264.3.01008 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, 미국
        • 1264.3.01055 Boehringer Ingelheim Investigational Site
      • Atlanta, Georgia, 미국
        • 1264.3.01061 Boehringer Ingelheim Investigational Site
      • Blue Ridge, Georgia, 미국
        • 1264.3.01074 Boehringer Ingelheim Investigational Site
      • Cartersville, Georgia, 미국
        • 1264.3.01084 Boehringer Ingelheim Investigational Site
      • Perry, Georgia, 미국
        • 1264.3.01060 Boehringer Ingelheim Investigational Site
      • Savannah, Georgia, 미국
        • 1264.3.01050 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, 미국
        • 1264.3.01077 Boehringer Ingelheim Investigational Site
    • Indiana
      • Brownsburg, Indiana, 미국
        • 1264.3.01052 Boehringer Ingelheim Investigational Site
      • Evansville, Indiana, 미국
        • 1264.3.01075 Boehringer Ingelheim Investigational Site
      • Evansville, Indiana, 미국
        • 1264.3.01076 Boehringer Ingelheim Investigational Site
      • Franklin, Indiana, 미국
        • 1264.3.01073 Boehringer Ingelheim Investigational Site
    • Kansas
      • Wichita, Kansas, 미국
        • 1264.3.01002 Boehringer Ingelheim Investigational Site
      • Wichita, Kansas, 미국
        • 1264.3.01007 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Lexington, Kentucky, 미국
        • 1264.3.01010 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, 미국
        • 1264.3.01028 Boehringer Ingelheim Investigational Site
      • Sunset, Louisiana, 미국
        • 1264.3.01029 Boehringer Ingelheim Investigational Site
    • Maryland
      • Hyattsville, Maryland, 미국
        • 1264.3.01069 Boehringer Ingelheim Investigational Site
    • Michigan
      • Southfield, Michigan, 미국
        • 1264.3.01066 Boehringer Ingelheim Investigational Site
    • Montana
      • Great Falls, Montana, 미국
        • 1264.3.01057 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Burlington, North Carolina, 미국
        • 1264.3.01045 Boehringer Ingelheim Investigational Site
      • Charlotte, North Carolina, 미국
        • 1264.3.01044 Boehringer Ingelheim Investigational Site
    • Ohio
      • Zanesville, Ohio, 미국
        • 1264.3.01022 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국
        • 1264.3.01032 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Fleetwood, Pennsylvania, 미국
        • 1264.3.01051 Boehringer Ingelheim Investigational Site
      • Pittsburgh, Pennsylvania, 미국
        • 1264.3.01025 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Columbia, South Carolina, 미국
        • 1264.3.01081 Boehringer Ingelheim Investigational Site
      • Greer, South Carolina, 미국
        • 1264.3.01003 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Kingsport, Tennessee, 미국
        • 1264.3.01011 Boehringer Ingelheim Investigational Site
    • Texas
      • Corpus Christi, Texas, 미국
        • 1264.3.01017 Boehringer Ingelheim Investigational Site
      • Dallas, Texas, 미국
        • 1264.3.01067 Boehringer Ingelheim Investigational Site
      • Houston, Texas, 미국
        • 1264.3.01004 Boehringer Ingelheim Investigational Site
      • Houston, Texas, 미국
        • 1264.3.01039 Boehringer Ingelheim Investigational Site
      • Houston, Texas, 미국
        • 1264.3.01041 Boehringer Ingelheim Investigational Site
      • Houston, Texas, 미국
        • 1264.3.01047 Boehringer Ingelheim Investigational Site
      • Houston, Texas, 미국
        • 1264.3.01070 Boehringer Ingelheim Investigational Site
      • Killeen, Texas, 미국
        • 1264.3.01040 Boehringer Ingelheim Investigational Site
      • Midland, Texas, 미국
        • 1264.3.01048 Boehringer Ingelheim Investigational Site
      • New Braunfels, Texas, 미국
        • 1264.3.01030 Boehringer Ingelheim Investigational Site
      • North Richland Hills, Texas, 미국
        • 1264.3.01071 Boehringer Ingelheim Investigational Site
      • Plano, Texas, 미국
        • 1264.3.01085 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, 미국
        • 1264.3.01046 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, 미국
        • 1264.3.01056 Boehringer Ingelheim Investigational Site
  • 스페인
      • Badía del Vallès - Barcelona, 스페인
        • 1264.3.34013 Boehringer Ingelheim Investigational Site
      • Barcelona, 스페인
        • 1264.3.34001 Boehringer Ingelheim Investigational Site
      • Barcelona, 스페인
        • 1264.3.34008 Boehringer Ingelheim Investigational Site
      • Borges del Camp- Tarragona, 스페인
        • 1264.3.34005 Boehringer Ingelheim Investigational Site
      • Canet de Mar - Barcelona, 스페인
        • 1264.3.34006 Boehringer Ingelheim Investigational Site
      • Centelles - Barcelona, 스페인
        • 1264.3.34010 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat, 스페인
        • 1264.3.34009 Boehringer Ingelheim Investigational Site
      • L'Hospitalet de Llobregat - Barcelona, 스페인
        • 1264.3.34004 Boehringer Ingelheim Investigational Site
      • Sant Adrià del Besós- Barcelona, 스페인
        • 1264.3.34002 Boehringer Ingelheim Investigational Site
      • Tarrega - Lleida, 스페인
        • 1264.3.34007 Boehringer Ingelheim Investigational Site
      • Valencia, 스페인
        • 1264.3.34012 Boehringer Ingelheim Investigational Site
      • Vic - Barcelona, 스페인
        • 1264.3.34011 Boehringer Ingelheim Investigational Site
  • 에스토니아
      • Harju, 에스토니아
        • 1264.3.37207 Boehringer Ingelheim Investigational Site
      • Pärnu, 에스토니아
        • 1264.3.37209 Boehringer Ingelheim Investigational Site
      • Tallin, 에스토니아
        • 1264.3.37203 Boehringer Ingelheim Investigational Site
      • Tallin, 에스토니아
        • 1264.3.37204 Boehringer Ingelheim Investigational Site
      • Tallin, 에스토니아
        • 1264.3.37205 Boehringer Ingelheim Investigational Site
      • Tallinn, 에스토니아
        • 1264.3.37201 Boehringer Ingelheim Investigational Site
      • Tallinn, 에스토니아
        • 1264.3.37202 Boehringer Ingelheim Investigational Site
      • Tallinn, 에스토니아
        • 1264.3.37208 Boehringer Ingelheim Investigational Site
      • Tartu, 에스토니아
        • 1264.3.37206 Boehringer Ingelheim Investigational Site
      • Viljandi County, 에스토니아
        • 1264.3.37210 Boehringer Ingelheim Investigational Site
  • 영국
      • Annan, 영국
        • 1264.3.44032 Boehringer Ingelheim Investigational Site
      • Ash Vale, Aldershot, 영국
        • 1264.3.44028 Boehringer Ingelheim Investigational Site
      • Baillieston, Glasgow, 영국
        • 1264.3.44029 Boehringer Ingelheim Investigational Site
      • Balham, 영국
        • 1264.3.44008 Boehringer Ingelheim Investigational Site
      • Bradford on Avon, 영국
        • 1264.3.44021 Boehringer Ingelheim Investigational Site
      • Burbage, 영국
        • 1264.3.44019 Boehringer Ingelheim Investigational Site
      • Chesterfield, 영국
        • 1264.3.44012 Boehringer Ingelheim Investigational Site
      • Chestfield, Whitstable, 영국
        • 1264.3.44027 Boehringer Ingelheim Investigational Site
      • Chippenham, 영국
        • 1264.3.44011 Boehringer Ingelheim Investigational Site
      • Johnstone, 영국
        • 1264.3.44033 Boehringer Ingelheim Investigational Site
      • Midsomer Norton, 영국
        • 1264.3.44007 Boehringer Ingelheim Investigational Site
      • Paisley, 영국
        • 1264.3.44034 Boehringer Ingelheim Investigational Site
      • Warminster, 영국
        • 1264.3.44031 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:

  1. Diagnosis of type 2 diabetes mellitus prior to informed consent
  2. Male and female patients with insufficient glycaemic control (HbA1c >= 7.0 to <= 10.5% at Visit 2) on diet and exercise alone, without oral antidiabetic drug therapy within 10 weeks prior to start of the run-in period (date of Visit 2)
  3. Age >= 18 and <= 80 years at start date of Visit 1 (Screening)
  4. BMI <= 45 kg/m2 (Body Mass Index) at start date of Visit 1 (Screening)
  5. Signed and dated written informed consent by start date of Visit 1 in accordance with GCP and local legislation

Exclusion criteria:

  1. Uncontrolled hyperglycaemia with a confirmed glucose level > 240 mg/dl (> 13.3 mmol/l) after an overnight fast during screening or placebo run-in period (cf. Section 3.3.4.1)
  2. Myocardial infarction within 6 months, stroke or TIA within 3 months prior to informed consent
  3. Clinical evidence of active liver disease (e.g. jaundice) or the ALT level > 2.5 times the upper limit of normal (according to pioglitazone label)
  4. Bariatric surgery, performed within the past 2 years prior to informed consent or planned at the time of informed consent
  5. Gastrointestinal surgeries prior to informed consent that induce chronic malabsorption
  6. Known hypersensitivity or allergy to the investigational products (linagliptin and/or pioglitazone) or their excipients (including matching placebos)

  7. Contraindications to pioglitazone as defined in the local prescribing information (SPC), particularly :

    • Diagnose of heart failure or history of heart failure
    • Haemodialysis patients, due to limited experience with pioglitazone
  8. Treatment with gemfibrozil, montelukast, trimethoprim, or rifampicin - according to pioglitazone label and respective restrictions in Section 4.2.2
  9. Treatment with rosiglitazone, pioglitazone, GLP-1 analogues, or insulin within 3 months prior to informed consent
  10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent
  11. Alcohol or drug abuse within the 3 months prior to informed consent or history of alcoholism
  12. Current treatment with systemic corticosteroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
  13. Participation in another trial with an investigational drug within 30 days prior to informed consent
  14. Any other clinical condition as judged by the investigator that would not allow the safe completion of the protocol, e.g. inability of patients to comply with study procedures

  15. Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who:

    • are nursing or pregnant or
    • are of child-bearing potential (i.e. not permanently sterilised) and are not practicing a highly effective method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.

    A highly effective method of birth control is defined - according to the Note for Guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) - as those which result in a low failure rate (i. e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices/systems (IUDs/IUSs), sexual abstinence or vasectomised partner

  16. Symptomatic gallbladder disease in the last six months
  17. Medical history of pancreatitis.
  18. Patients with urinary bladder cancer or a history of urinary bladder cancer or uninvestigated macroscopic haematuria
  19. Any other contraindication or restriction for use of pioglitazone in accordance with the local prescribing information for pioglitazone.

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
활성 비교기: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily
의약품: Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
활성 비교기: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
의약품: Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
활성 비교기: Pioglitazone 45 mg
Pioglitazone Capsules 45 mg once daily
의약품: Pioglitazone 45 mg
Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
활성 비교기: Linagliptin 5mg
Linagliptin 5mg Tablets once daily
의약품: Linagliptin 5mg
Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
실험적: Linagliptin 5mg / Pioglitazone 15 mg
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
의약품: Linagliptin 5mg / Pioglitazone 15 mg FDC
Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
실험적: Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
의약품: Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
실험적: Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
의약품: Linagliptin 5mg / Pioglitazone 45 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in HbA1c After 30 Weeks of Treatment.
기간: Baseline and 30 weeks
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
Baseline and 30 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
기간: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 6.5% After 30 Weeks of Treatment
기간: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 30 Weeks of Treatment)
기간: Baseline and 30 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin.
Baseline and 30 weeks
HbA1c Change From Baseline by Visit Over Time
기간: Baseline, week 6, week 12, week 18, week 24, week 30

HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes fixed effects for treatment, continuous baseline HbA1c, prior andi-diabetic medication, country, visit and treatment.

by visit interaction.
Baseline, week 6, week 12, week 18, week 24, week 30
Fasting Plasma Glucose (FPG) Change From Baseline After 30 Weeks of Treatment
기간: Baseline and 30 weeks
The change from baseline is the FPG after 30 weeks minus the baseline FPG.
Baseline and 30 weeks
Fasting Plasma Glucose (FPG) Change From Baseline by Visit Over Time
기간: Baseline, week 6, week 12, week 18, week 24, week 30
The change from baseline is the FPG over time minus the baseline FPG. Model includes fixed effects for treatment, continuous baseline FPG, continuous baseline HbA1c, prior anti-diabetic medication, country, visit and treatment by visit interaction
Baseline, week 6, week 12, week 18, week 24, week 30
Two-hour Postprandial Glucose (2hPPG) Change From Baseline at Week 30 by Meal Tolerance Test (MTT)
기간: Baseline and 30 weeks
The change from baseline is the 2hPPG after 30 weeks minus the baseline 2hPPG.
Baseline and 30 weeks
Time to First Use of Rescue Therapy
기간: 30 weeks
Proportion of patients at 30 weeks with rescue therapy using Kaplan-Meier analysis.
30 weeks
Incidence of Rescue Therapy During the First 30 Weeks of Treatment
기간: 30 weeks
Rescue therapy was defined to include any new antidiabetic medication taken for hyperglycemia and introduced on or after the start date of study treatment and before the end date of study treatment.
30 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

협력자

Eli Lilly and Company

간행물 및 유용한 링크

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

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

2010년 8월 1일

기본 완료 (실제)

2013년 2월 1일

연구 완료 (실제)

2013년 2월 1일

연구 등록 날짜

최초 제출

2010년 8월 16일

QC 기준을 충족하는 최초 제출

2010년 8월 16일

처음 게시됨 (추정)

2010년 8월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 10월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 10월 9일

마지막으로 확인됨

2014년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1264.3
  • 2008-008127-15 (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. .

구독하다