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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.
Study NCT00418522.   Last updated on November 24, 2008.
Information provided by Pfizer
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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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary endpoints include the following at week 26: [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of patients achieving HbA1c < 6.5% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of clinical adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Proportion of patients achieving HbA1c < 7.0 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in postprandial blood glucose excursions as measured by 8-point profiles and as determined by standardized meal tolerance tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of patients achieving HbA1c < 8.0% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence and severity of hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Incidence and severity of nocturnal hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Change from baseline in 24-hour mean glucose values, and glycemic variability measured by CGMS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in body weight and body mass index (BMI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of patients who discontinue due to insufficient clinical response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in treatment satisfaction, diabetes related quality of life, mental health and energy/vitality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Characterization of a 24-hour glucose profile in a subset of patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Diabetes Mellitus, Type 2
Drug: insulin glargine
Drug: Inhaled Insulin (Exubera)
To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site
 
Completed
415
February 2007
August 2008

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, OAs)
  • 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 alanine aminotransferase (ALT) >1.5 UNL as a result of hepatic steatosis are permitted to enter the study.
Both
30 Years to 75 Years
No
United States,   Puerto Rico
 
NCT00418522
A2171095
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2008
January 3, 2007
November 24, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.