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This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus

2026年7月20日 更新者：Pfizer

A Six Month, Open Label, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents

This study is to determine if inhaled insulin is effective in treating type 2 diabetes mellitus.

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)

413

阶段

  • 第四阶段

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

  • 波多黎各
      • Carolina、波多黎各、00983
        • Pfizer Investigational Site
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85051
        • Pfizer Investigational Site
      • Tucson、Arizona、美国、85712
        • Pfizer Investigational Site
    • California
      • Concord、California、美国、94520
        • Pfizer Investigational Site
      • Encino、California、美国、91436
        • Pfizer Investigational Site
      • Fresno、California、美国、93720
        • Pfizer Investigational Site
      • Fullerton、California、美国、92835
        • Pfizer Investigational Site
      • Long Beach、California、美国、90806
        • Pfizer Investigational Site
      • Mission Viejo、California、美国、92691
        • Pfizer Investigational Site
      • Pasadena、California、美国、91105
        • Pfizer Investigational Site
      • San Diego、California、美国、92120
        • Pfizer Investigational Site
      • San Diego、California、美国、92128
        • Pfizer Investigational Site
      • San Luis Obispo、California、美国、93401
        • Pfizer Investigational Site
      • Spring Valley、California、美国、91978
        • Pfizer Investigational Site
      • Stockton、California、美国、95204
        • Pfizer Investigational Site
      • Walnut Creek、California、美国、94598
        • Pfizer Investigational Site
      • West Hills、California、美国、91307
        • Pfizer Investigational Site
    • Colorado
      • Golden、Colorado、美国、80401
        • Pfizer Investigational Site
    • Connecticut
      • Waterbury、Connecticut、美国、06708
        • Pfizer Investigational Site
    • Delaware
      • Newark、Delaware、美国、19713
        • Pfizer Investigational Site
    • Florida
      • Chiefland、Florida、美国、32626
        • Pfizer Investigational Site
      • Clearwater、Florida、美国、33765
        • Pfizer Investigational Site
      • Hollywood、Florida、美国、33023
        • Pfizer Investigational Site
      • Kissimmee、Florida、美国、34741
        • Pfizer Investigational Site
      • Miami、Florida、美国、33156
        • Pfizer Investigational Site
      • Ocala、Florida、美国、34471
        • Pfizer Investigational Site
      • Saint Cloud、Florida、美国、34769
        • Pfizer Investigational Site
      • Winter Park、Florida、美国、32789
        • Pfizer Investigational Site
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Pfizer Investigational Site
      • Lawrenceville、Georgia、美国、30045
        • Pfizer Investigational Site
      • Lawrenceville、Georgia、美国、30045-3388
        • Pfizer Investigational Site
      • Woodstock、Georgia、美国、30189
        • Pfizer Investigational Site
    • Idaho
      • Boise、Idaho、美国、83702
        • Pfizer Investigational Site
      • Hayden Lake、Idaho、美国、83835
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis、Indiana、美国、46254
        • Pfizer Investigational Site
    • Kansas
      • Overland Park、Kansas、美国、66211
        • Pfizer Investigational Site
      • Topeka、Kansas、美国、66606
        • Pfizer Investigational Site
    • Kentucky
      • Lexington、Kentucky、美国、40503
        • Pfizer Investigational Site
      • Louisville、Kentucky、美国、40213
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge、Louisiana、美国、70808
        • Pfizer Investigational Site
      • New Orleans、Louisiana、美国、70121
        • Pfizer Investigational Site
    • Massachusetts
      • Haverhill、Massachusetts、美国、01830-6141
        • Pfizer Investigational Site
    • Missouri
      • Springfield、Missouri、美国、65807
        • Pfizer Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国、68131
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas、Nevada、美国、89104
        • Pfizer Investigational Site
    • New York
      • Staten Island、New York、美国、10301
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte、North Carolina、美国、28209-3734
        • Pfizer Investigational Site
      • Statesville、North Carolina、美国、28625
        • Pfizer Investigational Site
      • Winston-Salem、North Carolina、美国、27103
        • Pfizer Investigational Site
    • Ohio
      • Kettering、Ohio、美国、45429
        • Pfizer Investigational Site
      • Maumee、Ohio、美国、43537-9402
        • Pfizer Investigational Site
      • Toledo、Ohio、美国、43606
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73103
        • Pfizer Investigational Site
    • Oregon
      • Medford、Oregon、美国、97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Melrose Park、Pennsylvania、美国、19027
        • Pfizer Investigational Site
    • South Carolina
      • Greenville、South Carolina、美国、29615
        • Pfizer Investigational Site
      • Greer、South Carolina、美国、29651
        • Pfizer Investigational Site
      • Spartanburg、South Carolina、美国、29303
        • Pfizer Investigational Site
    • Tennessee
      • Milan、Tennessee、美国、38358
        • Pfizer Investigational Site
    • Texas
      • Arlington、Texas、美国、76014-2010
        • Pfizer Investigational Site
      • Beaumont、Texas、美国、77701
        • Pfizer Investigational Site
      • Dallas、Texas、美国、75231
        • Pfizer Investigational Site
      • Dallas、Texas、美国、75230
        • Pfizer Investigational Site
      • Dallas、Texas、美国、75246
        • Pfizer Investigational Site
      • El Paso、Texas、美国、79935
        • Pfizer Investigational Site
      • Houston、Texas、美国、77008
        • Pfizer Investigational Site
      • Houston、Texas、美国、77083
        • Pfizer Investigational Site
      • San Antonio、Texas、美国、78229
        • Pfizer Investigational Site
      • San Antonio、Texas、美国、78229-3900
        • Pfizer Investigational Site
    • Vermont
      • Bennington、Vermont、美国、05201-5018
        • Pfizer Investigational Site
    • Virginia
      • Richmond、Virginia、美国、23249
        • Pfizer Investigational Site
    • Washington
      • Federal Way、Washington、美国、98003
        • Pfizer Investigational Site
    • Wisconsin
      • Menomonee Falls、Wisconsin、美国、53051
        • Pfizer 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

30年 至 75年 (成人、年长者)

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age > 30 years and ≤ 75 years with a diagnosis of type 2 diabetes mellitus made > 6 months prior to study entry
  • Screening HbA1c > 7.0%
  • Currently treated on a stable dose of at least 2 oral antidiabetic agents for at least 3 months prior to study entry; including a sulfonylurea and/or metformin, and/or a thiazolidinedione

Exclusion Criteria:

Smoking within last 6 months PFTs outside of range

  • Type 1 diabetes mellitus
  • Type 2 diabetes mellitus currently (last three months) treated with an insulin regimen (alone or with Oral Antidiabetic Agents)
  • Active liver disease; significantly-impaired hepatic function, as shown by, but not limited to, alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) or aspartate transaminase (AST) serum glutamic-oxaloacetic transaminase (SGOT) above 2x the upper limit of normal as measured at visit 1. However, patients with elevated ALT >1.5 upper limit of normal as a result of hepatic steatosis are permitted to enter the study.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Insulin glargine
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
药品：Insulin glargine
Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
实验性的：Exubera
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
药品：Inhaled Insulin (Exubera)
Initiation dose of one mg per meal, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.

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 Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
大体时间：Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

次要结果测量

结果测量
措施说明
大体时间
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
大体时间：Week 26
Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.
Week 26
Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26
大体时间：Week 26
Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.
Week 26
Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26
大体时间：Week 26
Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.
Week 26
Change From Baseline in Fasting Plasma Glucose at Week 26
大体时间：Baseline, Week 26
Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26
大体时间：Baseline, Week 26
Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26
大体时间：Baseline, Week 26
Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Lipids at Week 26
大体时间：Baseline, Week 26
Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26
大体时间：Baseline, Week 26
CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26
大体时间：Baseline, Week 26
CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26
大体时间：Baseline, Week 26
24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26
大体时间：Baseline, Week 26
SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Number of Subjects With Hypoglycemic Events
大体时间：Months 1 to 7
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
Months 1 to 7
Number of Total Hypoglycemic Events
大体时间：Months 1 to 7
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.
Months 1 to 7
Number of Total Subject Months of Treatment
大体时间：Months 1 to 7
Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
Months 1 to 7
Crude Hypoglycemic Event Rate
大体时间：Months 1 to 7
crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.
Months 1 to 7
Number of Nocturnal Hypoglycemic Events
大体时间：Months 1 to 7
A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.
Months 1 to 7
Change From Baseline in Body Weight at Week 26
大体时间：Baseline, Week 26
Body weight value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26
Change From Baseline in Body Mass Index (BMI) at Week 26
大体时间：Baseline, Week 26
BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

其他结果措施

结果测量
措施说明
大体时间
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
大体时间：Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

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

Pfizer

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

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

2007年3月1日

初级完成 (实际的)

2008年8月1日

研究完成 (实际的)

2008年8月1日

研究注册日期

首次提交

2007年1月3日

首先提交符合 QC 标准的

2007年1月4日

首次发布 (估计的)

2007年1月5日

研究记录更新

最后更新发布 (实际的)

2026年8月11日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2025年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A2171095

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.

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