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

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin glargine Drug: Inhaled Insulin (Exubera)	Phase IV

MedlinePlus related topics:

Diabetes

Drug Information available for:

Insulin Insulin glargine Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Measures:

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 ]

Enrollment:	415
Study Start Date:	February 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
glargine: Active Comparator Glargine insulin, 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: insulin glargine Glargine insulin, 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.
Exubera: Experimental 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.	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.

Eligibility

Ages Eligible for Study:	30 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418522

Show 73 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A2171095
First Received:	January 3, 2007
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00418522
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

insulin, diabetes, HbA1c

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Glargine

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00418522