Clinical trial NCT00418522: This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Insulin Glargine Diabetes HbA1c
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 413
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26
timeFrame: Week 26
measure: Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26
timeFrame: Week 26
measure: Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26
timeFrame: Week 26
measure: Change From Baseline in Fasting Plasma Glucose at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Lipids at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26
timeFrame: Baseline, Week 26
measure: Number of Subjects With Hypoglycemic Events
timeFrame: Months 1 to 7
measure: Number of Total Hypoglycemic Events
timeFrame: Months 1 to 7
measure: Number of Total Subject Months of Treatment
timeFrame: Months 1 to 7
measure: Crude Hypoglycemic Event Rate
timeFrame: Months 1 to 7
measure: Number of Nocturnal Hypoglycemic Events
timeFrame: Months 1 to 7
measure: Change From Baseline in Body Weight at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Body Mass Index (BMI) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 Vitality Domain Questionnaire
timeFrame: Baseline, Week 26
Other outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS
timeFrame: Baseline, Week 26
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Concord
country: United States
facility: Pfizer Investigational Site
state: California
city: Encino
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Fullerton
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Mission Viejo
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Luis Obispo
country: United States
facility: Pfizer Investigational Site
state: California
city: Spring Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Stockton
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: West Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Golden
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Waterbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Chiefland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Cloud
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Park
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Woodstock
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Hayden Lake
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Topeka
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Haverhill
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Staten Island
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Maumee
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Melrose Park
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Milan
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bennington
country: United States
facility: Pfizer Investigational Site
state: Vermont
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Federal Way
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Menomonee Falls
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Carolina
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: