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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

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 Outcome Measure ^†

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 ]

Condition ^†

Diabetes Mellitus, Type 2

Intervention ^†

Drug: insulin glargine
Drug: Inhaled Insulin (Exubera)

MEDLINE PMIDs

Links

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

415

Start Date ^†

February 2007

Completion Date

August 2008

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, 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.

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Puerto Rico

Administrative Information Fields

NCT ID ^†

NCT00418522

Organization ID

A2171095

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2008

First Received Date ^†

January 3, 2007

Last Updated Date

November 24, 2008

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