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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00418522
First received: January 3, 2007
Last updated: September 8, 2009
Last verified: July 2009

January 3, 2007
September 8, 2009
March 2007
August 2008   (final data collection date for primary outcome measure)
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
Demonstrate non-inferiority of dry powder inhaled insulin (EXUBERA) compared to insulin glargine (LANTUS) in terms of glycemic control (HbA1c) after 26 weeks of treatment
Complete list of historical versions of study NCT00418522 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Plasma Glucose at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Lipids at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Number of Subjects With Hypoglycemic Events [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Number of Total Hypoglycemic Events [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Number of Total Subject Months of Treatment [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Crude Hypoglycemic Event Rate [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Number of Nocturnal Hypoglycemic Events [ Time Frame: Months 1 to 7 ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Mass Index (BMI) at Week 26 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline, Week 26 ] [ Designated as safety issue: No ]
  • Secondary endpoints include the following at week 26:
  • Proportion of patients achieving HbA1c < 6.5%
  • Proportion of patients achieving HbA1c < 7.0
  • Proportion of patients achieving HbA1c < 8.0%
  • Change from baseline in fasting plasma glucose level
  • Change from baseline in postprandial blood glucose excursions as measured by 8-point profiles and as determined by standardized meal tolerance tests
  • Change from baseline in fasting and postprandial plasma glucose, lipids (such as total cholesterol, HDL-c, LDL-c, triglycerides) and CV biomarkers (such as hs-CRP, leptin, adiponectin and apoB and spot urine microalbumin)
  • Change from baseline in 24-hour mean glucose values, and glycemic variability measured by CGMS
  • Incidence and severity of hypoglycemia
  • Incidence and severity of nocturnal hypoglycemia
  • Change from baseline in body weight and body mass index (BMI)
  • Proportion of patients who discontinue due to insufficient clinical response
  • Incidence of clinical adverse events
  • Change from baseline in treatment satisfaction, diabetes related quality of life, mental health and energy/vitality
  • Characterization of a 24-hour glucose profile in a subset of patients
Not Provided
Not Provided
 
This Study Is To Determine If Inhaled Insulin Is Effective In Treating Type 2 Diabetes Mellitus
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: 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.
  • Drug: 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.
  • Active Comparator: 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.
    Intervention: Drug: Insulin glargine
  • Experimental: 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.
    Intervention: Drug: Inhaled Insulin (Exubera)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
413
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00418522
A2171095
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP