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

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

2026년 7월 20일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

413

단계

  • 4단계

연락처 및 위치

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

연구 장소

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

30년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

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: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
의약품: 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.
실험적: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
기간: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline, Week 26
BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

기타 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
기간: Baseline, Week 26
HbA1c lab value: Change = value at Week 26 minus value at Baseline.
Baseline, Week 26

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

수사관

  • 연구 책임자: Pfizer CT.gov Call Center, Pfizer

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

2007년 3월 1일

기본 완료 (실제)

2008년 8월 1일

연구 완료 (실제)

2008년 8월 1일

연구 등록 날짜

최초 제출

2007년 1월 3일

QC 기준을 충족하는 최초 제출

2007년 1월 4일

처음 게시됨 (추정된)

2007년 1월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 20일

마지막으로 확인됨

2025년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A2171095

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. .

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