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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418522
• Other study ID #: A2171095
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	Pfizer Investigational Site	Carolina
United States	Pfizer Investigational Site	Arlington	Texas
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Baton Rouge	Louisiana
United States	Pfizer Investigational Site	Beaumont	Texas
United States	Pfizer Investigational Site	Bennington	Vermont
United States	Pfizer Investigational Site	Boise	Idaho
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Chiefland	Florida
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Concord	California
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	El Paso	Texas
United States	Pfizer Investigational Site	Encino	California
United States	Pfizer Investigational Site	Federal Way	Washington
United States	Pfizer Investigational Site	Fresno	California
United States	Pfizer Investigational Site	Fullerton	California
United States	Pfizer Investigational Site	Golden	Colorado
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Haverhill	Massachusetts
United States	Pfizer Investigational Site	Hayden Lake	Idaho
United States	Pfizer Investigational Site	Hollywood	Florida
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Kettering	Ohio
United States	Pfizer Investigational Site	Kissimmee	Florida
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Lawrenceville	Georgia
United States	Pfizer Investigational Site	Lexington	Kentucky
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Maumee	Ohio
United States	Pfizer Investigational Site	Medford	Oregon
United States	Pfizer Investigational Site	Melrose Park	Pennsylvania
United States	Pfizer Investigational Site	Menomonee Falls	Wisconsin
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Milan	Tennessee
United States	Pfizer Investigational Site	Mission Viejo	California
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Newark	Delaware
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Richmond	Virginia
United States	Pfizer Investigational Site	Saint Cloud	Florida
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	San Luis Obispo	California
United States	Pfizer Investigational Site	Spartanburg	South Carolina
United States	Pfizer Investigational Site	Spring Valley	California
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Staten Island	New York
United States	Pfizer Investigational Site	Statesville	North Carolina
United States	Pfizer Investigational Site	Stockton	California
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Topeka	Kansas
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Walnut Creek	California
United States	Pfizer Investigational Site	Waterbury	Connecticut
United States	Pfizer Investigational Site	West Hills	California
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Winter Park	Florida
United States	Pfizer Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the FAS	HbA1c lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Primary	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population	HbA1c lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Percentage of Subjects Achieving Glycemic Control (HbA1c < 6.5%) at Week 26	Percentage of subjects with glycosylated hemoglobin A1c lab value less than 6.5%.	Week 26
Secondary	Percentage of Subjects Achieving Glycemic Control (HbA1c < 7.0%) at Week 26	Percentage of subjects with glycosylated hemoglobin A1c lab value less than 7.0%.	Week 26
Secondary	Percentage of Subjects Achieving Glycemic Control (HbA1c < 8.0%) at Week 26	Number of subjects with glycosylated hemoglobin A1c lab value less than 8.0%.	Week 26
Secondary	Change From Baseline in Fasting Plasma Glucose at Week 26	Fasting plasma glucose lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Change From Baseline in Fasting and Postprandial Blood Glucose as Determined by Standardized Meal Tolerance Tests at Week 26	Postprandial blood glucose lab value (Time 0 min [fasting], Time 30 min, Time 60 min, Time 90 min, Time 120 min, Time 180 min): Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Change From Baseline in Postprandial Blood Glucose as Measured by 8-Point Profiles at Week 26	Post-prandial=after a meal. 8-point scale: (1 = before breakfast, 2 = 2 hours post breakfast, 3 = before lunch, 4 = 2 hours post lunch, 5 = before dinner, 6 = 2 hours post dinner, 7 = at bedtime, 8 = overnight [between 2 and 4 am]). Postprandial blood glucose lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Change From Baseline in Lipids at Week 26	Lipid (total cholesterol, high density lipoprotein cholesterol [HDL-c], low density lipoprotein cholesterol [LDL-c], triglycerides) lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Change From Baseline in Cardiovascular (CV) Biomarkers High Sensitivity C-reactive Protein (Hs-CRP), Leptin, and Spot Urine Microalbumin at Week 26	CV biomarker (hs-CRP, Leptin, and Spot Urine Microalbumin) lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Change From Baseline in CV Biomarkers Adiponectin and Apolipoprotein B (ApoB) at Week 26	CV biomarker (adiponectin and ApoB) lab value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Change From Baseline in 24-Hour Continuous Glucose Monitoring System (CGMS) Glucose Values at Week 26	24-Hour CGMS glucose lab value was obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Change From Baseline in Mean Standard Deviation (SD) of 24-Hour Glucose Values Measured by CGMS at Week 26	SD of 24-Hour CGMS glucose lab value obtained using the Medtronic MiniMed CGMS. Not all subjects were offered the opportunity to participate in this assessment. Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Number of Subjects With Hypoglycemic Events	A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. An event was severe if the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.	Months 1 to 7
Secondary	Number of Total Hypoglycemic Events	A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe. Total=events during the study.	Months 1 to 7
Secondary	Number of Total Subject Months of Treatment	Number of total subject months of treatment. Subject months = number of days from start of treatment to the last day of active treatment + 1 day lag, including off-drug time)/30.44. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.	Months 1 to 7
Secondary	Crude Hypoglycemic Event Rate	crude event rate=(events)/(subject-months). Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Overall=mild, moderate, and severe.	Months 1 to 7
Secondary	Number of Nocturnal Hypoglycemic Events	A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Severe=the subject was unable to treat him/herself; had at least 1 neurological symptom; or blood glucose of < = 49 mg/dL. Events not meeting all 3 criteria were considered mild-moderate. Nocturnal hypoglycemia=event occuring from midnight to 5:59 am.	Months 1 to 7
Secondary	Change From Baseline in Body Weight at Week 26	Body weight value: Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	Change From Baseline in Body Mass Index (BMI) at Week 26	BMI value (kg/m2): Change = value at Week 26 minus value at Baseline.	Baseline, Week 26
Secondary	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	Due to cancellation of the EXUBERA program, the collected Patient Reported Outcome (PRO) data, including the Diabetes Treatment Satisfaction Questionnaire-Status, Diabetes Treatment Satisfaction Questionnaire-Change, Diabetes-39, Mental Health Inventory-17, and SF-36 vitality domain questionnaire were not summarized, and no statistical analyses were performed.	Baseline, Week 26

External Links

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