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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

2014年10月9日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

936

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Pioglitazone 15 mg
Pioglitazone Capsules 15 mg once daily
药品：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
有源比较器：Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily
药品：Pioglitazone 30 mg
Pioglitazone Capsules 30 mg once daily for up to 84 weeks
有源比较器：Pioglitazone 45 mg
Pioglitazone Capsules 45 mg once daily
药品：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
有源比较器：Linagliptin 5mg
Linagliptin 5mg Tablets once daily
药品：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
实验性的：Linagliptin 5mg / Pioglitazone 15 mg
Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily
药品：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
实验性的：Linagliptin 5mg / Pioglitazone 30 mg
Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily
药品：Linagliptin 5mg / Pioglitazone 30 mg FDC
Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
实验性的：Linagliptin 5mg / Pioglitazone 45 mg
Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily
药品：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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in HbA1c After 30 Weeks of Treatment.
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Occurrence of Cumulative Treat to Target Efficacy Response, of HbA1c Under Treatment of < 7.0% After 30 Weeks of Treatment
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boehringer Ingelheim

合作者

Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年8月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年2月1日

研究注册日期

首次提交

2010年8月16日

首先提交符合 QC 标准的

2010年8月16日

首次发布 (估计)

2010年8月17日

研究记录更新

最后更新发布 (估计)

2014年10月20日

上次提交的符合 QC 标准的更新

2014年10月9日

最后验证

2014年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1264.3
  • 2008-008127-15 (EudraCT编号：EudraCT)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

Pioglitazone 15 mg的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Bosnia & Herzegovina

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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